Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma (NCT03843294) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma
United States18 participantsStarted 2019-06-24
Plain-language summary
This is a Phase I, open-label multi-site trial designed to evaluate the safety of administering rapidly-generated Tumor associated antigen specific T cells (TAA-T) with the Programmed Death1 (PD-1) inhibitor Nivolumab, in relapsed/refractory lymphoma (rel/ref) patients with measurable disease (group A) or as adjunctive therapy following autologous hematopoeitic stem cell transplant(HSCT) for patients at high risk of relapse (group B).
The purpose of this study is to find out if the tumor specific T cells given with Nivolumab are safe and to learn what the side effects are and if the combination can help patients with relapsed lymphomas.
Who can participate
Age range
12 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Disease Specific Inclusion Criteria
Group A (patients with measurable disease) Relapsed/Refractory Hodgkin Lymphoma (HL) and Diffuse Large B cell Lymphoma (DLBCL) DLBCL
* Patients who have failed at least 2 lines of prior therapy with a failed attempt at both an autologous stem cell transplant and chimeric antigen receptor T cell therapy.
* Patients who are deemed autologous stem cell transplant ineligible and have failed only one line of prior therapy.
* Systemic therapies to treat prior indolent lymphomas count towards previous DLBCL lines of therapy unless the treatment was anti-CD20 antibody monotherapy.
HL
* Rel/ref HL failing more than or equal to 1 salvage regimens, including prior Brentuximab Vedotin (BV)
* Rel/ref after autologous HSCT
Group B (consolidation after auto-HSCT for patients at high risk for relapse) DLBCL
* Patients with \< CMR/CR (by PET/CT) with initial treatment regimen
* Patients with relapse \<12 months from diagnosis or \<6 months from completion of initial therapy
* Patients with \<CMR/CR (by PET/CT) prior to autologous HSCT
* Patients requiring \>1 salvage regimen prior to autologous HSCT HL
* Patients with relapse \<12 months from diagnosis or \<6 months from completion of initial therapy
* Patients with \<CMR/CR (by PET/CT) prior to autologous HSCT
* Patients requiring \>1 salvage regimen prior to autologous HSCT
Recipient Inclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation):
* Age \>12 years
* Karnofsky/La…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Product-Emergent Adverse Events
Timeframe: 6 weeks from the first TAA-T cell administrations