Clinical trial: NCT04473937
Section: Duration of Study Involvement
Subsections: During This Research?

Existing medical records, including mental health records.  
New health information created from study-related tests, procedures, visits, and/or questionnaires  
Why will protected information about me be used or shared with others?  
The main reasons include the following:
To conduct and oversee the research described earlier in this form; To ensure the research meets legal, institutional, and accreditation requirements; To conduct public health activities (including reporting of adverse events or situations where you or others may be at risk of harm); and To provide the study sponsor with information arising from an adverse event or other event that relates to the safety or toxicity of the treatment used in the study and for the purpose of this or other research relating the study treatment and their use in cancer; To better understand the diseases being studied and to improve the design of future studies; and, Other reasons may include for treatment, payment, or health care operations. For example, some medical information produced by this research study may become part of your hospital medical record because the information may be necessary for your medical care. (You will also be given a notice for use and sharing of protected health information.)
Who will use or share protected health information about me?  
DF/HCC and its affiliated research doctors and entities participating in the research will use and share your protected health information. In addition, other DF/HCC offices that deal with research oversight, billing or quality assurance will be able to use and share your protected health information.  
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DFCI Protocol Number: 19-861 Approved Date (DFCI IRB Approval): 09/17/2021  
  
Date Posted for Use: 10/08/2021  
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates **OHRS 10.29.2019**  
With whom outside of DF/HCC **may my protected health information be shared?**
While all reasonable efforts will be made to protect the confidentiality of your protected health information, it may also be shared with the following entities:
Outside individuals or entities that have a need to access this information to perform functions relating to the conduct of this research such as analysis by outside laboratories on behalf of DF/HCC and its affiliates (for example, data storage companies, insurers, or legal advisors).  
The sponsor of the study, its subcontractors, representatives, business partners, and its agent: DF/HCC The funder of the study, its subcontractors, representatives, business partners, and its agent: Internal MGH Pilot Grant Other research doctors and medical centers participating in this research, if applicable Federal and state agencies (for example, the Department of Health and Human Services, the Food and Drug Administration, the National Institutes of Health, and/or the Office for Human Research Protections), or other domestic or foreign government bodies if required by law and/or necessary for oversight purposes. A qualified representative of the FDA and the National Cancer Institute may review your medical records. Hospital accrediting agencies A data safety monitoring board organized to oversee this research, if applicable For how long will protected health information about me be used or shared with
Clinical trial: NCT04473937
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: If Treatment Involves Any Regions Of Chest: Possible (Less Than 50% Chance Of

occurrence)
Pneumonitis, or inflammation of the lungs. This may cause a cough, shortness of breath, and may require treatment with antibiotics and/or hospitalization Page 9 of 22  
DFCI Protocol Number: 19-861 Approved Date (DFCI IRB Approval): 09/17/2021  
Date Posted for Use: 10/08/2021  
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates **OHRS 10.29.2019**
Esophagitis, or inflammation, irritation or swelling of the esophagus (the tube that leads from the back of the mouth to the stomach)
Rare (<1% at 10 years following radiation):
Years following radiation therapy, you have a small risk of developing a cancer within the radiation field that was caused by radiation therapy and is unrelated to your lymphoma. The treatment of this cancer would depend on the type of cancer that develops, and may or may not be curable.  
Cancer research often includes biopsies, scans, x-rays that are also provided as routine care. The following describes the side effects of procedures done only for the purposes of research. Risks Associated with Biopsies: Biopsies are normally performed under the guidance of an imaging technique. Each procedure requires a separate consent prior to the biopsy. The risks may include:
Pain and discomfort. The amount of pain and discomfort will vary, depending on the location of the biopsy site. These risks can be discussed with the study doctor. Minor bleeding at the biopsy site. Tenderness at the biopsy site. Scarring at the biopsy site. Rarely, an infection at the biopsy site.  
Uncommonly, complications from biopsies can be life threatening. As with any interventional procedure, other potentially serious complications from bleeding or organ damage may occur. These might require additional surgical intervention. Risks Associated with Lumbar Puncture: Prior to the lumbar puncture, you will be given a local anesthetic to numb the area. The procedure may cause headache, local pain or discomfort, bleeding, or infection. After the procedure, you may develop a headache that may be accompanied by nausea, vomiting, and dizziness. There is a rare, but serious risk of cerebral herniation in which the brain is squeezed through the base of the skull, which may be fatal. Reproductive Risks: The treatment used in this research study may affect a fetus. While participating in this research study, you should not:
Page 10 of 22 DFCI Protocol Number: 19-861 Approved Date (DFCI IRB Approval): 09/17/2021 Date Posted for Use: 10/08/2021 BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates **OHRS 10.29.2019**  
Become pregnant Nurse a baby Father a baby
D. WHAT WILL HAPPEN IF I AM REMOVED FROM THE STUDY OR DECIDE TO END MY
Clinical trial: NCT04473937
Section: Procedures
Subsections: Before The Research Starts (Screening And Enrollment):|Blood Tests Research Blood Samples

In this research study, we want to systematically investigate the safety and efficacy of radiotherapy following CAR T cell therapy in refractory lymphoma. The CAR T cell therapy you have been receiving involves genetically modifying your T cells to target tumor cells for death. Radiotherapy uses high-energy x rays, or particles, to destroy or damage cancer cells. Radiotherapy following CAR T cell therapy may have the potential to improve your immune system's response to cancer cells. Further, radiotherapy may interact with CAR T cell therapy to better treat your disease. Before research begins, there will be a Screening and Enrollment Period. Screening will occur no longer than 14 days from tumor biopsy (biopsy must be within 90 days of CAR T infusion). After Screening is completed, study enrollment will occur within 28 days of screening. Radiotherapy on study will occur within 14 days after study enrollment. Screening: After signing this consent form, you will be asked to undergo some screening tests or procedures to find out if you can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated.  
A medical history, **which includes questions about your health, current**
medications, and any allergies. Medical history may also include assessments of any symptoms of central nervous malignancy you may be experiencing, including severe headaches and neck stiffness. Performance status, **which evaluates how you are able to carry on with your usual** activities. An assessment of your disease status, which includes **PET-CT (Positron** Emission Tomography-Computerized Tomography) scan Physical Exam, which may include height and weight measurements.  
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Vital signs, **which includes blood pressure, heart rate, oxygen saturation and** temperature measurements. Blood tests, totaling approximately 2 tablespoons, **to check the health of** various body systems via standard laboratory tests. Tumor Biopsy **may be performed. Fresh tumor biopsies are preferred; however,** archival tissue (previously collected and stored tissue) is acceptable if obtained prior to the screening period, but following CAR T infusion. A biopsy may not be performed at the discretion of your study doctor. Not applicable to all patients: Lumbar Puncture, also known as a spinal tap, **may**
be performed to examine cerebral spinal fluid based on findings from physical exam. This will only be performed if you exhibit certain symptoms of the central nervous system, such as severe headaches or neck stiffness, as determined by your study doctor if there is concern for lymphoma involving the brain or spinal cord. A biopsy of suspected tumor within the brain or spinal cord may not be feasible - as such, CSF analysis can help provide information regarding the tumor pathology. This a procedure used to obtain a sample of cerebrospinal fluid (CSF). This fluid covers the brain and the spinal cord. When a lumbar puncture is performed, a hollow needle goes through the skin at the bottom of your spine, because this is where it can be done most easily and safely. The CSF comes out through the needle and a few drops are collected. Your study doctor may require CSF because it is the fluid that has come into closest contact with the brain itself. By analyzing the CSF, they will have more information about how the brain may be affected by a medical condition. You will feel a small sharp pinch at the site where the needle is inserted, and local or general anesthesia is often used to make the procedure painfree.  
If these tests show that you are eligible to participate in the research study, you may begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.  
Enrollment: Once Screening is complete, Enrollment will occur within 14 days of beginning radiotherapy. During Enrollment, you may undergo the following:
Questionnaires, which will take approximately 20 minutes. **Questionnaires include** questions about how you are feeling and any symptoms you may be experiencing. Radiotherapy Planning, **where your study doctor determines what dose and** schedule of radiotherapy will be administered to you.  
Page 5 of 22 BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates **OHRS 10.29.2019**
Study Treatment Overview:
Radiotherapy: **you will receive radiotherapy based on the dose and schedule** determined by your study doctor.  
Radiotherapy Treatment Period: You will have weekly clinic visits during the Radiotherapy Treatment Period. The duration of the Radiotherapy Treatment Period depends on the radiotherapy schedule determined by your study doctor. These visits may involve the following:
Radiotherapy Performance status Physical exam Vital signs Research blood samples, totaling approximately 2 tablespoons, **which may** include the following:
o **Pharmacodynamics, to understand the effects of your previous CAR T cell**
therapy on your body following radiotherapy.  
o **Biomarkers, which are indicators in the blood and may be related to how your**
body reacts to the study treatment.  
Planned Follow-up: We would like to keep track of your medical condition. Keeping in touch with you and checking your condition helps us look at the long-term effects of the research study. There will be a Post-Radiotherapy Period and a Long-Term Follow-Up Period. Post-Radiotherapy Period: You will be seen weekly for one month following completion of radiotherapy. These visits may involve the following:
Performance status Questionnaires Tumor Biopsy, **which will occur one time 7-14 days after completing radiotherapy.** This may or may not be performed at the discretion of your study doctor.  
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Long Term Follow-Up:
Long term follow up will continue through 12 months after last CAR T infusion. **This follow-up**
period will allow detection of any delayed side effects and provide information about the longterm effects of the study treatment. Long-Term Follow-Up visits occur at 6, 9, and 12 months.  
After month 24, you will be followed via the CIBMTR immune effector cell therapy registry. The CIBMTR is an FDA mandated long-term follow-up registry for every individual treated with an immune effector cell therapy. The study team is required to submit this data.  
These visits may include the following:
Physical exam Questionnaires An assessment of your disease status**, which includes a PET-CT scan at 6 and** 12 months Blood tests Research blood samples In addition, you can stop participating in the research study at any time, however, the FDA requires that any information collected up to the point of your withdrawal cannot be removed from the study.  
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| DFCI Protocol Number: 19-861    | Approved Date (DFCI IRB Approval): 09/17/2021   |
|---------------------------------|-------------------------------------------------|
| Date Posted for Use: 10/08/2021 |                                                 |  
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates **OHRS 10.29.2019**  
Post-Radiotherapy **Long Term**  
Follow-Up Screening **Enrollment**  
Day 0 Weekly Week 1 Week 2 Week 3 Week 4 **6, 9, 12**  
Months  
Medical History X Performance Status  
X X X X  
Questionnaires  
X X X  
Tumor Biopsy  
X3 X1  
Disease  
Assessment (PETCT Scan)  
X  
X2  
Radiotherapy  
Planning X  
Physical Exam  
X X X  
Vital Signs  
| Follow-Up                                            |                                                       |    |
|------------------------------------------------------|-------------------------------------------------------|----|
| Screening                                            |                                                       |    |
| Enrollment                                           |                                                       |    |
| Medical History                                      | X                                                     |    |
| Performance StatusQuestionnairesTumor BiopsyDisease  |                                                       |    |
| Assessment (PETCT Scan)                                                      |                                                       |    |
| X                                                    |                                                       |    |
| Radiotherapy                                         |                                                       |    |
| Planning                                             |                                                       |    |
| X                                                    |                                                       |    |
| Physical ExamVital Signs                             | X X                                                   |    |
| Blood TestsResearch Blood                            |                                                       |    |
| Samples                                              |                                                       | X  |
| Radiotherapy                                         | X                                                     | X  |
| 1.                                                   | Will be collected per your study doctor's decision    |    |
| 2.                                                   | Radiotherapy                                          |    |
| PET-CT scan will occur at the 6- and 12-month visits |                                                       |    |
| 3.                                                   | Tumor biopsy must be within 90 days of CAR T infusion |    |  
X X X X X X X X  
Research Blood  
Samples X  
X X X X X X  
Radiotherapy X  
Tumor biopsy must be within 90 days of CAR T infusion  
C. WHAT ARE THE RISKS OR DISCOMFORTS OF THE RESEARCH STUDY?  
There are risks to taking part in any research study. One risk is that you may get a study treatment that does not help treat your disease or that makes your condition or disease  
worse. Another risk is that there may be side effects.
Clinical trial: NCT04473937
Section: Purpose of Research
Subsections: Research Study Plan:|Research Study?

All cancer treatments can have side effects, which can range from mild and reversible to severe, long lasting and possibly life-threatening. There is a great deal of variability among side effects of different cancer treatments and between individuals. In a research study, all of the risks or side effects may not be known before you start the study. **You** need to tell your doctor or a member of the study team immediately if you experience any side effects.  
Page 8 of 22 BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates **OHRS 10.29.2019**
Everyone in the research study will be watched carefully for side effects. You will be monitored during the administration of study treatment to keep track of your blood counts and organ function, particularly your kidney and liver function. If you experience side effects, they may go away after you stop taking the study treatment. Some side effects can be mild; but others can be long lasting and may never go away. Some may be lifethreatening or fatal.  
Since the effect of the study treatment taken with other medications may not be known, it is important that you tell the research doctor about all prescription and non-prescription drugs, herbal preparations and nutritional supplements that you are taking or planning to take. There may also be some foods that you should avoid while on this research study and your research doctor will review this information with you. During the research study, you will be notified of newly discovered side effects or significant findings, which may affect your health or willingness to participate. You may be asked to sign a new consent form that shows that you have been informed of new information relating to this research study.  
Risks Associated with Radiotherapy:
Likely (More than a 50% chance that this will happen)
Dermatitis, or irritation of the skin such as an itchy rash or swollen reddened skin Fatigue Skin redness and itchiness Tissue scarring may occur with radiation therapy to the region where you will receive radiation. This risk is dependent on the radiation dose and the region to which you will receive radiation. For example, the skin and muscles where radiation is delivered may appear tougher to the touch months to years following radiation therapy. Tissue scarring can involve organs inside the body, such as lung or intestines, but it is rare that you would get any symptoms from this. The detailed radiation planning process helps to reduce the risk of symptoms from radiation scar tissue involving body organs (less than 5% chance of occurrence).

The National Cancer Institute provides an online resource to help people participating in cancer clinical trials understand which services their insurance company is required by law to pay. This can be found at the website below or can be provided by the study team:
Clinical trial: NCT04473937
Section: Voluntary Participation
Subsections: Participation In The Research?

We can provide counseling about preventing pregnancy for either male or female study participants. Let your doctor know immediately if you become pregnant or find out that you are going to be the father of a child. If your partner becomes pregnant while you are on the study, it may be critical to share information regarding your participation in this research study with that person. Your research doctor should also be told if this happens. Non-Physical Risks: Because of side effects or the time required for tests and clinic visits while you are on this research study, you may be unable to keep up with your normal daily activities.  
You may be taken off the research study for any reason including:
It is considered to be in your best interest The study treatment or procedures are found to be unsafe or ineffective There is any problem with following study treatments and procedures You are a female and become pregnant or plan to become pregnant Your condition worsens A decision is made to end the study Or for other unforeseen reasons that make it necessary to stop your participation in the research study
You can also choose to stop participating in the research study at any time. Tell the research doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop. Leaving the research study will not affect your medical care outside of the research study. It is important to tell the research doctor if you are thinking about stopping so your research doctor can evaluate the risks from stopping the study treatment.  
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DFCI Protocol Number: 19-861 Approved Date (DFCI IRB Approval): 09/17/2021  
Date Posted for Use: 10/08/2021  
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates **OHRS 10.29.2019**
In some cases, the abrupt stopping of a treatment can have risks in itself. Another reason to tell your research doctor that you are thinking about stopping is to discuss what followup care and testing could be most helpful for you.  
E. WHAT ARE THE BENEFITS OF THIS RESEARCH STUDY?  
Taking part in this research study may or may not benefit you. We hope the information learned from this research study will provide more information about refractory lymphoma.  
WILL I BE PAID TO TAKE PART IN THIS RESEARCH STUDY?  
You will not be paid for participating in this study. It is important to note that although you may withdraw from study participation, the FDA requires that any information collected up to the point of your withdrawal cannot be removed from study records. Additionally, the research doctor may consult public records after you have withdrawn from the study.