Clinical trial: NCT04975698
Section: Confidentiality
Subsections: 7. Privacy, Confidentiality, And Use Of Information|10. Health Insurance Portability And Accountability Act 1 (Hipaa) Authorization To Use Health Information For Research

Your privacy is very important to us. The study doctors, study sponsor, and other groups with access to your study-related medical information will do everything they can to protect it. The study doctors can protect your records if there is a court case. However, some of your medical information may be shared if required by law. If this happens, the study doctors will do their best to make sure that any information that goes out to others will not identify you. Your confidentiality is one of our main concerns. We will do our best to make sure that the personal information in your medical record is kept confidential (private). However, we cannot promise total privacy. To make sure the study is running ethically, some government agencies or other groups may need to access part of your medical records. For this study, those groups include:

Your local study hospital will give you a separate form with information about the Health Insurance Portability and Accountability Act 1 (HIPAA). BMT CTN 1903: Administration of HIV-specific T cells to HIV+ Patients Receiving High Dose Chemotherapy Followed by Autologous Stem cell Rescue -Auto-RESIST
- I have read and understood this Consent Form. The purpose and description of the research study has been explained to me.  
- I have had the chance to ask questions, and understand the answers I have been given. I
understand that I may ask questions at any time during the study.  
- I freely agree to be a participant in the study.  
- I have had the chance to discuss my participation in this research study with a family member or friend if I choose.  
- I understand that…
o I may not directly benefit from taking part in the study.  
o My name and personal information will not be identified even if information gained during the study is published.  
o I can leave this study at any time, and doing so will not affect my current care or prevent me from receiving future treatment.  
o I will be given a copy of this signed consent form. o I do not give up any legal rights by signing this form.  
Participant Name (or Parent/Guardian) Date (MM/DD/YYYY) Participant Signature (or Parent/Guardian) Date (MM/DD/YYYY) Parent/Guardian Name Date (MM/DD/YYYY) Parent/Guardian Signature Date (MM/DD/YYYY) Clinician **certification** I certify that I have provided a verbal explanation of the details of the research study, including the procedures and risks. I believe the participant has understood the information provided. Clinician Name Date (MM/DD/YYYY) Clinician Signature Date (MM/DD/YYYY)
Clinical trial: NCT04975698
Section: Duration of Study Involvement
Subsections: During The Study

If you join the study, here's what will happen: about 6 weeks before your transplant, you'll give about 8 tablespoons of blood via a routine blood draw. You will also give blood so doctors can measure the amount of HIV in your body. The blood will be sent to a lab to make the HSTNEETs cells. The HST-NEET cells will be given to you through your central venous catheter, like a blood transfusion, 3-7 days after the autologous transplant for your lymphoma If it becomes clear that the lab cannot make the HST-NEETs with your cells supplied, additional blood samples may requested. Your doctor will notify you as soon as possible if this occurs. We will not delay your autologous transplant if the lab has trouble making the HST-NEETs. After you get the HST-NEETs, you'll have up to 8 routine autologous transplant check-ups to test your health. The schedule of tests are listed in **Table 1**. Your participation will last for 1 year after your transplant.
Clinical trial: NCT04975698
Section: Participant's Rights
Subsections: 5. Your Rights To Withdraw, Ask Questions, And Seek Other Treatment

Being in this study is your choice. You can choose not to be in this study or leave this study at any time. If you choose to not join or leave this study, it won't affect your regular medical care in any way. If at any time you are considering leaving the study, talk to your study doctor about your health and safety. You have the right to ask questions about the study at any time. If you have questions about the study, please contact:
Clinical trial: NCT04975698
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Possible Risks|Risks Of Medicines|Reproductive Risks|Unforeseen Risks|Physical Injury As A Result Of Participation

You may have side effects during the study. Side effects can range from mild to severe. Your health care team may give you medicine to help with certain side effects, like an upset stomach. In some cases, side effects can last a long time or may never go away. We don't expect that the HST-NEETs will have any effect on the lymphoma or the effectiveness of the autologous transplant, but don't know that for sure.

| Likely      | This side effect is expected to happen in more than 20% of patients.    |
|-------------|-------------------------------------------------------------------------|
| Less Likely | This side effect is expected to happen in 20% of patients or fewer.     |
| Rare, but   | This side effect does not happen often - in fewer than 2% of patients - |
| Serious     | but is serious when it happens.                                         |

The drugs used in autologous transplant are likely to affect your ability to have children. The HST-NEETs may also be associated with this risk. Doctors don't know all of the possible risks to your baby if you or your partner become pregnant during the study. It is important that both men who are able to father a child and women who can become pregnant use birth control from the time of the blood draw to create the HST-NEETs until 6 months after transplant while on this study. Tell your doctor right away if you become pregnant or if your partner becomes pregnant during the study. Your doctor will talk with you about the risks to your unborn child and your options. If you become pregnant, you may be asked to leave the study.

There are some trials regarding T-cell infusions that have been associated with serious, sometimes life-threatening, problems. These problems have only been seen with genetically modified T-cells which are not being used in this approach; however, this is a new therapy and unanticipated side effects may occur.The study team will do everything they can to keep you safe and lower your risk of side effects. For more information about risks and side effects, ask your study doctor.

Tell your study doctor or staff if you think you've been hurt because of being in this study. You'll get medical treatment if you're hurt as a result of this study. You and/or your health insurance company will be charged for this treatment. The study sponsor will not pay for medical treatment as a result of unintended injury. In case of injury resulting from this study, you don't lose any of your legal rights to seek payment by signing this form.
Clinical trial: NCT04975698
Section: Procedures
Subsections: 3. Study Treatment And Tests Before Your Treatment

You'll need to have several tests to see if you can be in the study. These tests are part of your regular care. They would be done even if you decide not to join this study. The tests include:
- Medical history and physical exam - Blood and urine tests - Tests to see how well your heart and lungs are working
- Tests to measure your lymphoma  
- A pregnancy test (if you could be pregnant)
You will be asked to agree to an autologous bone marrow transplant and the BEAM Conditioning Regimen using your hospital's standard procedure. BEAM includes four medications which are a standard treatment used before transplants for lymphoma. The BEAM medications are Carmustine (BCNU), Cytarabine (Ara-C), Etoposide (VP-16) and Melphalan. You will be asked to sign a separate consent for the transplant and conditioning regimen, even if you do not participate in this study. Risks and details about the procedure are described in that consent form. If you do not agree to the autologous transplant you cannot be in this study testing HST-NEETS since we need to test HST-NEETS after you have had treatment with BEAM.
Clinical trial: NCT04975698
Section: Purpose of Research
Subsections: 2. Study Purpose

We're doing this study to see if a type of cells called HST-NEETs can help your body fight HIV. HST-NEETs are cells made from your own immune cells that have been treated and grown in a lab. HST-NEETs have not been approved by the U.S. Food and Drug Administration (FDA) as a treatment for HIV. This study is registered with the FDA, and they will monitor it. This is a phase 2 study. Studies in this phase test how well a new treatment will work to treat a disease.
Clinical trial: NCT04975698
Section: Withdrawal from Study
Subsections: Stopping Treatment|You Must Tell [Insert Name Of Principal Investigator] If You Decide To Leave The Study.|8. Leaving The Study

We'll stop the treatment if:
- You don't meet the study requirements.  
- You need a medical treatment not allowed in this study.  
- You're too sick to safely get the HST-NEETs or transplant. - You become pregnant.  
- The study is stopped for any reason.  
| Tests                               | Pre-ASCT   | Day   | Day   | Day   | Day   | Day   | Day   | Day   | Day   |
|-------------------------------------|------------|-------|-------|-------|-------|-------|-------|-------|-------|
| 14                                  | 21         | 28    | 35    | 56    | 100   | 180   | 365   |       |       |
| Blood tests                         | X          | X     | X     | X     | X     | X     | X     | X     |       |
| Physical exam                       | X          | X     | X     | X     | X     | X     | X     | X     | X     |
| Blood, Chemistry and Toxicity       | X          | X     | X     | X     | X     | X     |       |       |       |
| Tests for side effects PET-CT or CT | X          | X     | X     | X     |       |       |       |       |       |
| Bone Marrow Biopsy for              | X          |       |       |       |       |       |       |       |       |
| Pathology                           |            |       |       |       |       |       |       |       |       |

If you choose not to join, other options are available. Your study doctor will talk with you about your options. If you decide not to join this study, your medical care will not be affected in any way. If you join this study, you cannot be in another clinical trial at the same time. Your other choices may include:
- Continue to get antiretroviral therapies to control HIV  
- Receive standard treatment for lymphoma
- Joining another clinical trial. Talk to your doctor to see if there is a trial you can join.
Every treatment option has benefits and risks. Talk with your doctor about your choices before you decide if you will be in this study.

You can choose to leave the study at any time. You may also be told to leave the study for reasons such as:
- You don't meet the study requirements. - You need a medical treatment not allowed in this study.  
- You're too sick to safely receive the HST-NEETs or transplant.  
- You become pregnant.  
- The study is stopped for any reason.
Even if you leave the study, the information already collected from you will be included in the study evaluation. If you don't want your information to be used, you **must** let your study doctor know.