Clinical trial NCT04639245
Conditions: Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Lung Non-Small Cell Carcinoma Metastatic Malignant Solid Neoplasm Metastatic Triple-Negative Breast Carcinoma Metastatic Urothelial Carcinoma Stage IV Lung Cancer AJCC v8
Sponsor: Fred Hutchinson Cancer Center
Start date: 2021-07-19; Completion date: 2022-08-16
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial investigates the side effects of genetically engineered cells called FH-MagIC TCR-T cells and how well they work with atezolizumab in treating patients with triple negative breast cancer, urothelial cancer, or non-small cell lung cancer that has spread to other places in the body (metastatic). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize MAGE-A1, a protein on the surface of tumor cells. These MAGE-A1-specific T cells may help the body's immune system identify and kill MAGE-A1 tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving FH-MagIC TCR-T cells with atezolizumab may help treat patients with triple negative breast cancer, urothelial cancer, or non-small cell lung cancer.

Detailed description:
OUTLINE:

This is a phase I, dose escalation study of FH-MagIC TCR-T cells followed by a phase II study.

LYMPHODEPLETION: Patients receive cyclophosphamide intravenously (IV) and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.

T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.

In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.

After completion of study treatment, patients are followed up annually for 15 years after final infusion of FH-MagIC TCR-T.

Arms: arm 1: LYMPHODEPLETION: Patients receive cyclophosphamide IV and fludarabine IV on days -4, -3, and -2 before each T-cell infusion.

T-CELL INFUSION: Patients receive FH-MagIC TCR-T cells IV over 15-20 minutes. Six to twelve weeks after first T-cell infusion, patients with progressive disease and non-persisting transgenic TCR T cells may receive a second T-cell infusion.

In the Phase 2 portion of the study, atezolizumab will be administered as standard of care beginning 24-72 hours after T-cell infusion. Atezolizumab will be given IV every 3 weeks for at least 1 year in the absence of disease progression or unacceptable toxicity. An alternative PD1 inhibitor may be substituted if atezolizumab (preferred) is not available.
Interventions: intervention 1: Atezolizumab intervention 2: Cyclophosphamide intervention 3: Fludarabine intervention 4: MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells intervention 5: PD1 Inhibitor
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV

Protocol documents:
Prot_SAP_001.pdf: 
IRO received 07/26/22
FHCRC IRB Approval  
8/18/2022 
Document Released Date















































































ICF_000.pdf: 
 
 
Official Title: 
ATTAMAGE-A1.: Phase I/II Study of Autologous CD8+ and 
CD4+ Transgenic T Cells Expressing High Affinity MAGE-A1-
Specific T-Cell Receptor (TCR) Combined With 
Atezolizumab in Patients With Metastatic MAGE-A1 
Expressing Cancer   
NCT number: 
NCT04639245 
Document Type:  
Informed Consent Form 
Date of the 
Document: 
02/11/2021 
 


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Fred Hutchinson Cancer Research Center 
The University of Washington School of Medicine 
Seattle Cancer Care Alliance 
Consent to receive treatment as part of a research study: 
ATTAMAGE-A1: Phase I/II study of Autologous CD8+ and CD4+ Transgenic T cells 
expressing high affinity MAGE-A1-specific T-Cell Receptor (TCR) combined with 
Atezolizumab in patients with metastatic MAGE-A1 expressing cancer 
Principal 
Investigator 
Professional Title 
Phone Number 
Michael Schweizer, 
MD 
Associate Professor, Fred Hutchinson Cancer 
Research Center 
Associate Professor, University of Washington 
(206) 606-6252
Investigators 
William Rayford 
Gwin III, MD 
Acting Instructor, Seattle Cancer Care Alliance 
Acting Instructor, Tumor Vaccine Group, University of 
Washington School of Medicine 
Sylvia Lee, MD 
Assistant Professor, Fred Hutchinson Cancer 
Research Center 
Assistant Professor, University of Washington 
School of Medicine 
(206) 606-2274
Cecilia Yeung, MD 
Associate Professor, Fred Hutch 
Associate Professor, University of Washington 
Pathologist, Seattle Cancer Care Alliance 
(206) 606-7104
Research Staff 
Monica Dherin 
Clinical Research Coordinator 
(206) 667-3403
Susan Hildebrandt 
Clinical Research Nurse 
(206) 667-7786
Emergency number (24 hours): 206-598-8902 
IRO received 01/12/21


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Important things to know about this study. 
You are invited to participate in a research study because you have advanced triple negative 
breast cancer (TNBC), urothelial carcinoma, or non-small cell lung cancer (NSCLC) that has 
recurred or not responded to prior conventional chemotherapy and may express a protein 
called MAGE-A1 . The purpose of this research is to see if we can take immune T cells from 
your blood, modify them in the laboratory so they specifically kill cancer cells and safely 
give them back to you after lymphodepleting chemotherapy.  
If you agree to join the study you will be asked to participate in pre-treatment procedures, 
collection of T cells, chemotherapy, T cell infusion and follow-up. You will be actively 
participating in the study for approximately 15 months. The total time includes the time for 
the T cells to be made, the T cell infusion, and for approximately 12 months after the T cell 
infusion is given.  
We do not know if treatment with genetically modified T cells will help your MAGE-A1 
expressing cancer, and this treatment could even make your condition/disease worse. 
Genetically modified T cells could cause side effects such as high fevers, low blood pressure, 
or neurotoxicity, as described below in this form.  
You do not have to join this study. You can choose to receive standard methods to treat your 
triple negative breast cancer (TNBC), urothelial carcinoma, or non-small cell lung cancer 
(NSCLC) cancer instead of participating in this study. We will give you details about the 
purposes, procedures, risks and possible benefits related to this study. We will explain other 
choices that you have. We will also give you any other information that you need in order to 
make an informed decision about joining this study.  
Following is a more complete description of this study. Please read this description carefully. 
You can ask any questions you want to help you decide whether to join the study. If you join 
this study, we will give you a signed copy of this form to keep for future reference. 
We would like you to join this research study. 
Protocol 10420 is a research study to find out if we can take immune T cells from your 
blood, modify them in the laboratory by adding new genes to make them kill cancer cells, 
and safely give them back to you after chemotherapy. T cells that have genes added in the 
laboratory are called ‘genetically modified’ T cells. In this case, the added gene encodes a so-
called T-cell receptor (TCR) that helps the T cells find and kill cancer cells.  
To determine the safest dose for T cell infusions, we will first treat patients one at a time 
starting at a low dose. At each cell dose level, one patient will be treated without 
lymphodepleting chemotherapy and, if considered safe, the next three patients will receive 
lymphodepleting chemotherapy. The purpose of this chemotherapy is to cause a low 
lymphocyte (white blood cell) count in your blood (termed lymphodepletion), which has 
been found to help the infused T cells survive and expand.  The first four patients will be 
treated at a low dose during their first and second infusion approximately 6-12 weeks later. 


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Once a group of patients has been treated at a certain dose cohort, we will look at the safety 
of that dose and decide if we should enroll an additional cohort of patients who will receive 
the addition of a PD1-axis therapy called atezolizumab. Atezolizumab is a human antibody 
that blocks a marker called PD-L1.  PD-L1 can be found on cells in a tumor and can interfere 
with the function of T cells.  The antibody has been used to improve the anti-tumor activity 
of T cells in many cancers.  This cohort of patients will receive a dose of atezolizumab 
approximately every 3 weeks following T cell infusion 
Up to 18 patients with either triple negative breast cancer (TNBC), urothelial carcinoma, or 
non-small cell lung cancer (NSCLC) that expresses MAGE-A1will be treated on this trial.   
The information we get from this study may shed light on the future potential for genetically 
modified T cells to be used to treat MAGE-A1 expressing cancers.    
You do not have to be in this study. You are free to say yes or no, or to drop out after joining. 
There is no penalty or loss of benefits if you say no. Whatever you decide, your regular 
medical care will not change. 
What research tests, procedures and infusions are part of this study? 
If you decide to join this study, we will do research tests and procedures, which are 
performed in addition to your usual care. This will include routine blood tests, including 
testing for viruses like hepatitis and HIV. Where possible we will try and schedule the times 
and locations of research tests to coincide with the tests done as part of your usual care.  
Procedures are outlined according to study periods:  pre-treatment, leukapheresis, T-cell 
manufacturing process, chemotherapy, T-cell infusion, and long-term follow-up. 
Pre-treatment 
Restaging of your disease may include the following tests: 
Tumor imaging studies.  You should have CT (Computed Tomography) scans with or 
without PET (Positron Emission Tomography) scans to determine the amount of disease you 
have prior to starting chemotherapy. 
Tumor Biopsy If you did not require a tumor biopsy during screening, a tumor biopsy may 
be obtained. There are two reasons you may undergo a tumor biopsy: 
•
Clinical biopsy: A tumor biopsy may be necessary for your clinical care, if obtained,
a research sample will be sent to the research lab.
•
Research tumor biopsies: If you have a tumor that your doctor thinks can be safely
biopsied, we would like to perform a biopsy procedure to get some tumor for
research. Similarly, should your doctor determine that a biopsy cannot be performed
safely for clinical reasons, biopsies may be cancelled or rescheduled. Your doctor will
explain the process and risks to you and tell you which tumor they feel is best to
biopsy. We would like to collect research biopsies prior to your first T cell infusion,


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1-4 weeks after each infusion and, should you relapse, a tumor biopsy may be 
requested at that time.  
The study team may also request some tissue from a previously collected biopsy for 
research. 
Blood tests: If there is a delay between your initial screening tests and your leukapheresis or 
blood draw for T cell collection, we may need to repeat the screening blood tests, which is a 
30 ml sample (6 teaspoons), closer to the time of T cell collection to help us plan the 
procedure. 
Other routine medical tests will be done to evaluate your heart, lungs and other organs to 
make sure it is safe to give you chemotherapy and T cell infusions. These may include a 
physical exam,  electrocardiogram (EKG), echocardiogram (ECHO) or a multi-gated 
acquisition (MUGA) and laboratory blood tests. 
If it is determined that we can likely make genetically modified T cells for you then we 
would like to proceed with the collection of your T cells. 
Leukapheresis - Collection of T cells 
T cells will be collected from your blood by a procedure called leukapheresis, a standard 
medical procedure in which needles are inserted into both arms and your blood is circulated 
through a machine before being returned to you.  You will be hooked up to the machine for 
1-4 hours. While you are on it, some white blood cells will be removed from your blood and 
collected in a sterile bag. You will be monitored carefully during the procedure.  
If you are not able to undergo leukapheresis because of poor venous access you may have a 
percutaneous central venous catheter inserted to support this collection.  
After T cells have been collected from your blood, they will be taken to our laboratory where 
we will insert a new gene into their DNA to make them kill cancer cells. These genetically 
modified T cells (called FH-MagIC TCR-T) will then be grown in the laboratory.  This 
process may take several weeks and may be difficult or impossible depending on how much 
prior chemotherapy you had.  If the genetically modified T cells can be made and grown in 
sufficient numbers, then we will schedule the T cell infusion to take place when clinically 
appropriate. 
Should a technical issue arise during the leukapheresis procedure or in the processing of the 
product, or if manufactured FH-MagIC TCR-T cells are insufficient for the prescribed FH-
MagIC TCR-T cell dose, a second leukapheresis procedure may need to be performed. 
Blood samples (also known as: PBMC) not required for cell selections may be archived for 
research.  
Chemotherapy  
The purpose of this chemotherapy is to cause a low lymphocyte (white blood cell) count in 
your blood (termed lymphodepletion), which has been found to help the infused T cells 


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survive and expand.  We will use a chemotherapy regimen including cyclophosphamide and 
fludarabine because we have found in other studies using this regimen provides the best 
lymphodepletion and T cell growth. 
Chemotherapy will be administered either at the Seattle Cancer Care Alliance (SCCA) or in 
the inpatient unit at the University of Washington Medical Center (UWMC) prior to each 
FH-MagIC TCR-T infusion. Risks associated with this chemotherapy are outlined in the 
‘Risks’ section of this consent form and will also be addressed by the treating physician.    
T cell infusion 
We will assess your health 36-96 hours after the chemotherapy to make sure you are well 
enough to receive a T cell infusion. 
Before you receive the T cell infusion, a blood test for research will be collected (60 ml, 
almost four tablespoons). 
The T cell infusion will be given into a vein. If you have a central venous access device 
(Port-a-cath) or other similar device to access your veins, we will try to use that to give the T 
cells.  
T-cell infusions and chemotherapies will be given at the Seattle Cancer Care Alliance or at 
the University of Washington Medical Center. All patients will be observed for 2 hours post 
infusion. If there is a need for hospitalization following the infusion, patients will be admitted 
to UWMC.  
Atezolizumab - a PD-L1 axis inhibitor: 
For a separate cohort of patients, you may receive an IV infusion of atezolizumab 
approximately every 3 weeks after your T-cell infusion. If an alternative FDA approved PD1-
axis inhibitor is available for a patient, it may be substituted. 
Each time you are due for an atezolizumab infusion we will assess your health to make sure 
you are well enough to receive the treatment. The atezolizumab infusions will be given into a 
vein. If you have a Hickman catheter or other similar device to access your veins, we will try 
to use that. 
Follow-up  
After treatment you will enter the active follow-up part of the study. In active follow-up, we will 
do these tests and procedures: 
Tumor imaging studies. CT scans with or without PET scans should be performed 1 month 
after each T cell infusion, and then approximately 3 months, 6 months, 9 months and 12 
months after the last T cell infusion. These tests are performed to restage your cancer to 
determine the effect of the T cell infusions. These tests are considered part of routine clinical 
care.   
Neurological Testing: A neurological evaluation will be done prior to your first infusion of 
T cells and then approximately weekly for one month. The evaluation, which takes about 10-


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15 minutes, is a series of simple questions and tests that provide important information about 
your nervous system.  
Blood tests. After the T cell infusion, we would like to take blood samples to study the T 
cells. We plan to collect samples at the following approximate times and amounts after your 
T cell infusion. These samples will be used to monitor the effects of the T cell infusion. We 
may collect additional samples, up to 40 ml (almost 3 tablespoons), at other times to evaluate 
your medical condition after the treatment. Some of the samples will be stored for analysis 
later. 
• At enrollment – 80 ml, about 5.5 tablespoons 
• 
The day of the infusion - 40 ml, about 3 tablespoons 
• 
One day – 50 ml, about 3.5 tablespoons 
• 
Three days – 30 ml, about 2.5 tablespoons  
• 
Seven days – 30 ml, about 2.5 tablespoons 
• 
Fourteen days – 80 ml, about 5.5 tablespoons 
• 
Twenty-one days – 40 ml, about 3 tablespoons 
• 
Twenty-eight days – 50 ml, about 3.5 tablespoons 
• 
Fifty-six days – 50 ml, about 3.5 tablespoons 
• 
Eighty-four days –80 ml, about 5.5 tablespoons 
• 
One hundred and eighty days – 80 ml, about 5.5 tablespoons 
• 
Two hundred and seventy days – 80 ml, about 5.5 tablespoons 
• 
Three hundred and sixty-five days - 80 ml, about 5.5 tablespoons 
How long will I be in this study? 
You will be actively participating in the study for approximately 15 months. The total time 
includes the time for the T cells to be made, the T cell infusion, and for approximately 12 
months after the T cell infusion is given. All patients who receive treatment with FH-MagIC 
TCR-T cells should be followed for at least 15 years after the final infusion for safety 
evaluations in the LTFU portion of the study.  The anticipated duration of the study, 
excluding LTFU assessments, is approximately 2 years.  
The study doctor or your doctor may take you out of this study at any time, whether you want 
to leave the study or not. This would happen if: 
• 
They think it is not in your best interest to continue in the study. 
• 
You are unable or unwilling to follow study procedures. 
• 
The Principal Investigator, the National Institutes of Health (NIH) or the Food 
and Drug Administration (FDA) stops the whole study. 


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If you are thinking about dropping out of this study, please tell the study doctor. The doctor 
can tell you about the effects of stopping. You and the doctor can talk about what follow-up 
care and testing would help you the most.  
If you leave the study, your test results and information cannot be removed from the study 
records.   
We would like to do long-term follow-up. 
Long-term follow-up means keeping track of your medical condition for the rest of your 
life. Long-term follow-up is not the same as the one-year period for this research study. It 
begins when your active participation in this research study ends, one year after you received 
your T cell infusion. 
The FDA requests that we ask people who receive an infusion of genetically modified T cells 
if they will participate in long-term follow-up for 15 years after they receive the genetically 
modified T cells.  
Although we would like you to do long-term follow-up, you do not have to agree to be in 
long-term follow-up. You can say yes or no. Either way, you can still join this study. If you 
drop out of the study, we will ask again if we may contact you once a year. 
If you choose not to join long-term follow-up, we will not contact you regularly after the 
study has finished, but we may still need to contact you for some other reason. 
If you agree to do long-term follow-up we will call you or your provider on the telephone or 
send you or your provider a letter or survey once a year to see how you are doing. We may 
ask you to see your physician for a complete exam and to have a blood test twice a year for 
the first 5 years then once a year after that. This will help us learn about the long-term effects 
of the T cell infusions. It will also help us let you know about health information that is 
related to this study and might be important to you.  
Request for autopsy - If you are a study participant, investigators may ask your family for 
permission to do an autopsy if you die, even though this may be years after the study. This 
may help investigators learn about the effects of treatment with genetically modified cells. 
By signing this consent form, you are not forcing your family to agree to this. You should 
talk about this request with your family and advise them of your wishes. 
What are the side effects (risks)? 
In this part of the consent form, we tell you the side effects we expect from the tests, 
chemotherapy and infusion of T cells in this study.  
The procedures used to get T cells from the blood, to genetically modify them with 
lentivirus, and to give them to people are experimental. The FDA will only allow these 
procedures to be used in research studies and they are not part of standard treatment.  


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With any new treatment or combination of treatments, there may be side effects that we do 
not know about and cannot predict. 
If we learn about other side effects, we will tell you. We carefully watch everyone in the 
study for side effects. If you want more information about side effects and risks, ask the 
doctor or nurse. 
You should talk to your doctor about any side effects that you have while you are in this 
study.  
If they occur, side effects may be mild or very serious. Your health care team may give you 
medicines to help lessen side effects. Many side effects go away soon after the T cell 
infusion stops. However, sometimes side effects can last a long time or never go away. There 
is a risk of death if unexpectedly severe side effects occur. 
Risks of study procedures 
Where possible, we will schedule study blood tests and other procedures to take place at the 
same times as your regular clinical tests to minimize any risks and discomfort. If you have 
the tests done separately, the extra risks are as follows. 
Blood tests 
The risks of blood tests depend on whether the blood is taken by needle directly from a vein 
or from a device, such as a port or central venous access device, that stays in place for blood 
tests. If blood is taken from a central venous access device, there is usually no pain or 
bruising. 
Likely side effects (≥ 20%) of blood tests are: 
• Temporary discomfort if blood is taken straight from a vein. 
• A small bruise or redness at the site from which the blood was taken. 
Less likely side effects (3-20%) of blood tests are: 
• Fainting, sweating or feeling sick in the stomach that gets better when you lie 
down and rest. 
• Bruising larger than a quarter coin. 
Rare but serious side effects (< 3%) of blood tests are: 
• Infection from the blood test.  
• Injury to blood vessels, nerves or other structures near the blood draw site. 
Risks of leukapheresis 
Likely side effects (≥ 20%) of leukapheresis are: 


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• 
Discomfort associated with the needle puncturing the skin and vein 
• 
A small bruise or redness at the needle stick 
• 
Temporary (1-2 days) decrease in your red blood cell count. 
• 
Temporary (up to 4 hours) decrease in the clotting ability of your blood 
Less likely side effects (3-20%) of leukapheresis are: 
• 
Fainting, sweating or feeling sick in the stomach that gets better when you lie down 
and rest. 
• 
Bruising larger than a quarter coin at the needle stick site. 
• 
During the collection, you may experience stiff arms, chilling sensations, faintness, 
and muscle cramping in the jaw or fingers and/or tingling around the mouth.  
Rare but serious side effects (< 3%) of leukapheresis are: 
• 
Infection from the blood collection. 
• 
Blood vessel disturbances from the needle irritating the vein.  
• 
Injury to blood vessels, nerves or other structures near the needle stick site. 
• 
Rarely, the muscle cramping during the collection may be severe. 
Symptoms from the procedure can be reduced or eliminated by slowing the procedure or 
giving a calcium supplement, either by mouth or as an infusion.  
If catheters cannot be placed in the blood veins in your arms to perform a leukapheresis, a 
central venous catheter will be needed. A separate consent form for the placement of that 
catheter will be required and will include a complete list of risks.  
In general, while the central line is in place you have an increased risk of a local infection 
around the catheter, which sometimes leads to a generalized infection in the blood. If this 
happens you will be treated with antibiotics. Clotting in the catheter could also occur and 
may require the catheter to be removed or treatment with medicines that dissolve blood clots. 
 
CT/PET Scans 
 
Some of the tests that you will have in this research study will expose you to radiation. 
Everyone receives a small amount of radiation every day called “background radiation”. 
This radiation is natural and comes from space, air, water, soil, and the food you eat. Each 
year you are exposed to about 3 milliSieverts (mSv) of this background radiation. A 
milliSievert is a unit of radiation dose. For comparison, the estimated radiation dose from 
each of these tests is listed below. 
• PET/CT:  19 mSv 


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Tumor Biopsy 
Likely side effects (≥ 20%) of tumor biopsy procedures are: 
• bruising 
• pain or discomfort from where the needle punctures the skin. 
Less likely side effects (3-20%) of tumor biopsy procedures are: 
• Infection from the biopsy.  
• Injury to blood vessels, nerves or other structures. 
Rare but serious side effects (< 3%) of tumor biopsy procedures are: 
• Serious reaction to the anesthesia drugs. 
Chemotherapy  
You will receive chemotherapy drugs prior to the T cell infusion with the preferred regimen 
of cyclophosphamide and fludarabine when possible. Giving chemotherapy before the T cell 
infusion is important to allow the transferred T cells to survive better in your body. The risks 
associated with these two drugs are outlined below. 
Cyclophosphamide: 
Likely side effects (≥ 20%) of cyclophosphamide: 
• 
Nausea, vomiting, diarrhea 
• 
Low white cells, which can increase your risk for infection 
• 
Low red cells (anemia) 
• 
Low platelets, which can increase your risk of bleeding 
• 
Ulcers in the mouth and intestines 
• 
Hair loss 
• 
Disruption of menstrual cycle (women) 
• 
Lower sperm count (men) 
Less likely side effects (3-20%) of cyclophosphamide: 
• 
Bladder irritation and bleeding 
• 
Severe infection requiring hospitalization 
Rare but serious side effects (< 3%) of cyclophosphamide: 
• 
Heart damage 
• 
Lung damage 


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•
Confusion, coma
•
Intestinal bleeding
•
Liver damage
•
Severe skin reaction
•
Blurred vision
•
Damage to bone marrow causing permanent inability to make normal blood cells
•
Cancer of blood or bladder
•
Death
Fludarabine: 
Likely side effects (≥ 20%) of fludarabine: 
•
Low white blood cell count with an increased risk of infection (from bacteria,
fungi or viruses)
•
Lower platelet count with an increased risk of bleeding
•
Anemia
•
Nausea (feeling sick to your stomach)
•
Vomiting
•
Diarrhea (loose stools)
Less likely side effects (3-20%) of fludarabine: 
•
Fatigue
•
Numbness and tingling in hands or feet
•
Visual changes
Rare but serious side effects (< 3%) of fludarabine: 
•
Rash
•
Confusion
•
Coma (at high-doses)
•
Pneumonia
Risks of receiving genetically modified T cells 
There are risks associated with genetically modifying cells. There are also risks associated with 
treatment with T cells. 


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Risks of genetic modification of cells 
The new gene is inserted into the DNA of the T cells using a virus called a lentivirus, which has 
been made in the laboratory. The lentivirus that we will use to insert the new gene into your T 
cells is experimental and the risks are not completely known. The FDA requires that the 
lentivirus be manufactured in highly specific conditions that allow it to be given to people. 
However, there are some risks associated with using lentiviruses to modify genes in cells. 
 
Development of cancers or other diseases.  
 
Researchers have wondered whether a transferred gene might sometimes land in a place 
in the DNA of a cell where it can cause harm. This appears to have happened in other 
studies in which five children who were treated with genetically modified blood stem 
cells subsequently developed leukemia. These children’s stem cells were genetically 
modified using a virus called a ‘retrovirus’. A group of experts found that the retrovirus 
caused the leukemia. These problems have not been seen in people who received T cells 
that were genetically modified with lentiviruses, the type of virus that we will use. 
Research studies suggest that these problems are less likely to occur with lentiviruses, but 
the exact risks are unknown.  
Transfer of the lentivirus and new gene to unintended cells or people.  
Lentiviruses used for genetic modification are made in a way that prevents the virus from 
reproducing. Although it has never been seen in people, it is possible that the lentivirus 
could change in a way that would allow it to reproduce itself. We do not know what the 
effects of this might be in people, but it is possible that the new virus could be passed to 
other cell types in the body, to other people with whom you have contact or to your 
children if they are conceived or born during or after T cell treatment. We will test for 
changes in the lentivirus, but the genetically modified T cells will be given to you before 
the results are available. 
Risks of infusion with genetically modified T cells in this study 
While T cells are being given it is very common for the recipients to have mild reactions that 
usually get better within 24 hours after the T cell infusion has finished. However, it is 
possible that unpredictable and unexpected severe or life-threatening reactions can occur 
during or after experimental T cell infusions.  After T cell infusions patients may develop 
more serious complications associated with the TCR-T cell growth and possibly tumor 
killing. 
Likely (≥ 20%) side effects of genetically modified T cell infusions include: 
• 
Fevers 
• 
Chills or shakes  
• 
Temporary changes in blood pressure 


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• 
Cytokine release syndrome. After being given to patients with cancer, genetically 
modified T cells become activated, which allows them to kill cancer cells. This 
usually occurs between one day and three weeks after the T cell infusion, and can 
be mild, requiring observation in hospital, or severe and life threatening, requiring 
intensive care treatment. Cytokine release syndrome can cause high fevers, low 
blood pressure, or abnormal heart, lung, kidney or liver function. In some patients 
cytokine release syndrome is associated with confusion, seizures or stroke-like 
symptoms, such as speech impairment, loss of coordination or reduced strength.  
The symptoms of severe cytokine release syndrome may last for weeks, but 
usually improve when the T cells become less activated. If cytokine release 
syndrome is very severe, treatments to suppress the genetically modified T cells 
may be needed. Fatal cytokine release syndrome can occur.  
• Neurotoxicity. In some patients neurotoxicity is associated with confusion, 
seizures or stroke-like symptoms, such as speech impairment, loss of coordination 
or reduced strength. 
Less likely (3-20%) side effects of genetically modified T cell infusions include: 
• 
Nausea or vomiting  
• 
Pain 
• 
Headache 
Rare (< 3%) but serious side effects of genetically modified T cell infusions include: 
• 
Risks due to genetic modification of T cells (see RISKS OF GENETIC 
MODIFICATION OF CELLS, above) 
• 
Infection can be transferred by the T cell infusion. This sometimes causes no 
symptoms, but it can rarely cause severe and life-threatening problems.  
• 
Severe allergic reactions to the materials used in the manufacture of the T cells 
rarely happen but can be very serious. Severe allergic reactions may occur during 
or shortly after the T cell infusion and can lead to breathing and blood pressure 
problems that might require intensive care treatment and life support.  
• 
Reactions can occur as a result of the T cells rapidly killing the tumor cells and 
they might be seen close to the time of the T cell infusion or some weeks 
afterwards. These reactions sometimes cause kidney problems or blood acid 
disturbances due to toxins being released from the tumor cells. 
• 
T cell infusion is an experimental procedure, and unexpected and unpredictable 
problems can occur that can be serious and could lead to death or permanent 
disability. 
Macrophage Activation Syndrome 
Macrophage activation syndrome (MAS) is a serious disorder potentially associated with 
uncontrolled stimulation and multiplying of TCR T cells and the subsequent stimulation 


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of macrophages (a type of white blood cell that consumes and digests cellular remains). 
Treatment with steroids and anti-cytokine drugs has been shown to improve the 
symptoms associated with MAS.  Macrophage activation syndrome is a theoretical risk 
but has occurred with other modified T cell therapies. 
Risk of damage to normal tissues expressing the MAGE-A1 antigen 
The possibility of causing severe or even fatal toxicity from the effects of anti-MAGE-A1 
TCR-T cells attacking normal tissues expressing the MAGE-A1 antigen are not 
known.  You will be monitored closely for any side effects and treatment will be given to 
suppress TCR-T cell proliferation if severe unexpected toxicity is encountered. 
Risks of Atezolizumab  
You may experience none, some or all of those listed below. The side effects of treatment 
with atezolizumab may be enhanced by treatment with genetically-modified T cells. 
More likely side effects (>10%): 
Headache  
Vomiting  
Infections (generally mild), including skin infection, Upper respiratory tract 
infection (cold), pneumonia, and bone and joint infections) 
Injection site reaction  
Fever  
Chills 
Rigors 
Less likely side effects (1% to 10%): 
Nausea  
Diarrhea  
Decreased white blood cell count  
Decrease or increase in platelet count  
Rare side effects (<1%) 
Hepatitis (noninfectious) 
Hypersensitivity reaction (including anaphylaxis, angioedema, pruritus, skin rash, 
urticaria) 
cancer 
Side effects of unknown frequency: 
Skin rash  
High cholesterol level 


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Reproductive risks 
You should not be in this study if you are planning a pregnancy soon. Because this is 
experimental research, we do not know what the risks due to infusion with genetically 
modified T cells might be in pregnant women. It is possible that unpredictable problems 
could occur in a pregnancy or baby that is conceived or born during or after you receive the T 
cell infusion.  
For women: 
• 
You should not become pregnant or nurse a baby while you are in this study and 
for 2 months after the infusion of genetically modified T cells. 
For women and men: 
• 
If you are having sex that could lead to pregnancy, you should use birth control 
while you are in this study and for 2 months after the infusion of genetically 
modified T cells. 
Check with your doctor about birth control methods and how long to use them. Some 
common methods might not be appropriate while you are in this study. 
• 
If you are planning a future pregnancy, discuss the options for storage of eggs or 
sperm before you begin this study. Loss of fertility can occur after chemotherapy. 
The additional effects of genetically modified T cell infusions on fertility are 
unknown. 
• 
If you or your partner becomes pregnant while on this study you should notify the 
study doctors immediately. 
Non-physical risks 
This study involves growing T cells in a laboratory. Sometimes T cells do not grow well, 
which could mean that you might not be able to receive the T cell infusion even if you 
received the lymphodepleting chemotherapy. Your regular medical care would not be 
affected. 
What are the benefits of participating in the study? 
We hope this study will help participants by providing them with T cells that target and kill 
advanced triple negative breast cancer (TNBC), urothelial carcinoma, or non-small cell lung 
cancer (NSCLC), but we do not know if it will. Infusion with genetically modified T cells is 
experimental, and we are testing it to find the highest safe dose. We hope the information 
from this study will help us find out if genetically modified T cells can help patients with 
MAGE-AI specific cancers in the future. 
You have other choices besides this study. 
You do not have to join this study. You are free to say yes or no. Your regular medical care 
will not change. 


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If you do not join this study, you have other choices for treatment. Each of these choices has 
risks and benefits. Talk to your doctor about your choices. 
Your other choices may include: 
• 
Additional conventional chemotherapy, biologic therapies or hormonal therapy. 
• 
Supportive care 
• 
A different research study 
Protecting your privacy as an individual and the confidentiality of your personal 
information  
Some people or organizations may need to look at your research records for quality assurance 
or data analysis. They include: 
· 
Researchers involved with this study. 
· 
SignalOne Bio, Inc., the study financial supporter, and their agents. 
· 
Institutional Review Boards (IRB), including the Fred Hutchinson Cancer 
Research Center IRB. An IRB is a group that reviews the study to protect your 
rights as a research participant. 
· 
Fred Hutchinson Cancer Research Center, University of Washington, and Seattle 
Cancer Care Alliance. 
· 
Office for Human Research Protections, Food and Drug Administration, and other 
agencies as legally required. 
We will do our best to keep your personal information confidential. but we cannot guarantee 
total confidentiality. Your personal information may be given out if required by law. For 
example, workplace safety rules may require health workers to contact you about lab tests. 
Or a court may order study information to be disclosed. Such cases are rare. 
We will not use your personal information in any reports about this study, such as journal 
articles or presentations at scientific meetings.  
In some cases, government agencies and medical journals may require us to make 
information about this study available to researchers outside of Fred Hutchin order to use or 
publish the results of this study.  In that case, we will remove your Personal Information 
before making the study information available.    
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you.  At 
most, the Web site will include a summary of the results. You can search this Web site at any 
time. 
If you join this study, information about your participation in this study such as the title of the 
study and the names of the researchers involved in the study will be made a part of your 
permanent medical record. This information would include a copy of this consent form. If an 


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insurance company, employer, or anyone else were authorized to see your medical record, they 
would see a copy of this consent form.  
How is my genetic information protected? 
A federal law called the Genetic Information Nondiscrimination Act (GINA) helps protect 
your genetic information.   
GINA restricts access to your genetic information so that it cannot be used for health 
insurance coverage decisions. GINA won't allow health insurance companies or group health 
plans to:   
• 
ask for your genetic information you have provided in research studies. 
• 
use your genetic information when making decisions regarding    
your eligibility or premiums. 
GINA does not help or protect you against genetic discrimination by companies that sell life, 
disability or long-term care insurance.   
Will you pay me to be in this study? 
There is no payment for being in this study. 
However, you or your caregiver are eligible for reimbursement of up to $3500.00 for travel 
expenses (i.e. airfare, mileage, parking and overnight accommodations) related to your 
participation in this study from the time of your consent to 30 days post your immunotherapy 
infusion.  
SignalOne Bio, Inc. also has no plans to share with you any profits or other compensation 
that come from any of its research related to this study. 
How much will this study cost me? 
 
You or your insurer will have to pay for the routine costs of treating your cancer in this 
study. Check with your insurer before you join this study as some insurers will not pay for 
research. Taking part in the study may lead to extra costs for you or your insurance company 
because of the possibility of additional hospitalizations, procedures and blood tests. 
The collection, production and infusion of the investigational T cells are paid for by 
SignalOne Bio, Inc. 
 
Medical and psychological resources of the SCCA and UWMC will be available as standard 
care. 
Should you choose to undergo research biopsy procedures, they will be conducted at no cost 
to you. 


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If you have any questions concerning your costs, financial responsibilities, and or medical 
insurance coverage for this activity, please contact the SCCA Patient Financial Services 
Department at (206) 606-6226. 
What if I get sick or hurt in this study? 
If you get sick or hurt in this study, tell the study doctor in person or call the SCCA 
Immunotherapy Clinic at (206) 606-6000.  
Emergency medical treatment is available at the usual charge. You or your health insurance 
will have to pay for the treatment. There are no funds to pay you for a research-related injury, 
added medical costs, loss of a job, or other costs to you or your family.  State or national law 
may give you rights to seek payment for some of these expenses.   
 
You or your insurer will be billed for treatment of problems or complications that result from 
your condition or from standard clinical care. 
You will not lose your legal right to seek payment for treatment if you sign this form. 
 
Financial interests of the center and certain center employees  
 
Fred Hutchinson Cancer Research Center (“Fred Hutch”) has filed a patent on the genetically 
modified T cells used in this study, and will receive royalty and other milestone payments 
from SignalOne Bio, Inc., the study financial sponsor. Fred Hutch will pay the scientists at 
Fred Hutch who were involved in the development of this process a share of payments 
received by Fred Hutch.  These payments are required by Fred Hutch’s Patents and 
Inventions Policy.  
 
Fred Hutch also owns stock in (in other words, are part owners of) SignalOne Bio, Inc. which 
is the company that has licensed the rights to develop the genetically engineered T cells and 
is providing financial support for this study.  Employees of Fred Hutch may also own stock 
in SignalOne Bio, Inc.    
 
Certain employees of Fred Hutch provide consulting services to SignalOne Bio, Inc. and 
receive outside income for this work that is more than $10,000 per year.  Other employees of 
Fred Hutch may in the future provide similar consulting services.     
 
No individual Fred Hutch employee that has any of the interests described in this Section is 
or will be, allowed to be directly involved in the conduct or oversight of this study. It is 
possible that some Fred Hutch employees with interests described in this section will provide 
expert clinical or scientific advice to the study team if requested. 
What will my information and/or tissue samples be used for? 
Your information and tissue samples (such as blood and tumor cells) will be used for the 
purposes of this study. 


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Your tissue samples might help researchers develop new products. This research could be 
done by for-profit companies. There is no plan to share with you any revenue generated from 
products developed using your tissue samples. 
During this study, if the researchers learn new information that may be important to your 
general health or to your disease or condition, they will share that information with you. 
In addition, be aware that by agreeing to participate in this study, your information or tissue 
samples and FH-MagIC TCR-T cell product made from your T cells but not used in the 
study, could be used for future research studies or sent to other investigators for future 
research studies without additional consent from you. These future research studies will be 
reviewed by an oversight group known as an institutional review board if required by law. 
The information that identifies you will first be removed from your information or tissue 
samples. If you do not want your information or tissue samples to be used for future research 
studies without your consent, you should not participate in this study. 
Samples may be sent to SignalOne Bio, Inc. or other institutions for research testing, 
analysis, and other immunotherapy research related to this study and for product 
development related to the FH-MagIC TCR-T cells and similar products. Prior to sending 
any of these samples, personal information that could easily identify you, such as your name, 
age, date of birth and medical record number will be removed.  These samples will be 
identified to the recipient by your study identification code.  There will be no cost to you for 
any of the independent testing and analysis of these samples. Data from this testing and 
analysis will not be part of your medical record and will not be provided to you.  
Your rights 
•
You do not have to join this study. You are free to say yes or no. Your regular
medical care will not change.
•
If you join this study, you do not have to stay in it. You may stop at any time (even
before you start). There is no penalty for stopping. Your regular medical care will not
change.
•
If you get sick or hurt in this study, you do not lose any of your legal rights to seek
payment by signing this form.
•
During the study, we may learn new information you need to know. For example,
some information may affect your health or well-being. Other information may make
you change your mind about being in this study. If we learn these kinds of
information, we will tell you.


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For more information 
If you have questions or concerns about this study, you may talk to your doctor anytime. 
Other people you can talk to are listed here. 
 
If you have questions about: 
 
Call: 
This study (including complaints 
and requests for information) 
 
206-667-3403 (Monica Dherin, CRC) 
If you get sick or hurt in this 
study 
 
206-606-6000 (SCCA Immunotherapy Clinic) 
Your rights as a research 
participant 
 
206-667-4867 (Director of Institutional Review Office, 
Fred Hutchinson Cancer Research Center) 
206-543-0098 (Human Subjects Division, University of 
Washington) 
Your bills and health insurance 
coverage 
 
206-606-6226 (SCCA Patient Financial Services) 
 
Emergency number (24 hours): 206-598-8902 


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We would like you to donate some of your tissue samples for other future research. 
During the study, samples of blood, bone marrow, tumor biopsies you agree to provide, other 
tissue, and T cells may be collected from you, and FH-MagIC TCR-T cells may be made 
from your T cells, as described above.  We refer to these materials as “samples.” After we do 
tests on your samples in this study, some samples may be left over. We would like you to 
donate these leftover samples for future research. This may include genetic research. 
You do not have to donate your tissue for research. You are free to say yes or no. Your 
regular medical care will not change. If we want to use your tissue for other research or share 
it with other scientists for research, an ethics review committee (IRB) will review the request. 
The IRB will decide if we need to ask for your consent to do the research. 
Your donated tissue will be stored in a secure location. and will be used for research and for 
other studies that might help to develop new treatments. These future research and drug 
development studies may be done by us at FHCRC or by for-profit companies including 
SignalOne Bio, Inc. which funded this study, and its collaborators. Researchers will not 
report their results to you or your doctor. The research results will not appear in your health 
record. They will not affect your care. 
Research on your tissue may help develop new products. If these products make money, 
there is no plan to share the money with you. 
If you donate your tissue for research, you can change your mind anytime. Just call Dr. 
Michael Schweizer at 206-606-6252 and tell us you do not want us to use your tissue. There 
is no penalty for changing your mind. Your regular medical care will not change. However, if 
you do change your mind, we cannot return donated tissue. We may be able to destroy tissue 
we know is yours. But if it is stored or shared anonymously (without any label saying who it 
belongs to), we cannot destroy it. In this case it would still be used for research, but no one 
would know it was yours 
Read each question and think about your choice. When you decide on each question, please 
circle YES or NO. 
Do you agree to donate your samples to study cancer and related diseases? (circle and initial 
one) 
YES 
NO 
 
Do you agree to donate your samples to study other health problems, such as diabetes, 
Alzheimer’s disease, or heart disease? (circle and initial one) 
YES 
NO 
Is it OK if someone contacts you in the future to ask you to donate more samples for 
research? 
(circle and initial one) 
YES 
NO 
 


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Read the statements below and initial next to the one that applies to you: 
Signature 
If you have read this form (or had it read to you), asked any questions, and agree to 
participate, please sign: 
Participant printed name (18 years or older) 
 Date 
____________________________________________________________________  
Participant signature 
If you served as an interpreter or witness during the consent process, sign below to indicate 
you attest to the accuracy of the presentation to the participant and the apparent 
understanding of the research by the participant. 
Witness or Interpreter / Printed Name, Signature, and Date 
Researcher’s statement 
I have discussed the research study, including procedures and risks, with the person 
signing above. A copy of the signed consent form will be given to the participant. 
Person obtaining consent printed name 
 Date 
____________________________________________________________________     
Person obtaining consent signature 
Protocol: 10420A 
Current version date: 08/04/2020 
Previous version date:  
Copies to: Patient, Medical Records, Research File 
________ I AGREE  to have a tumor biopsy to provide tumor for research.  
________ I DECLINE to have a tumor biopsy to provide tumor for research. 
FHCRC IRB Approval  
02/11/2021 
Document Released Date

Prot_SAP_002.pdf: