TAA-T Cells + Nivolumab for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byBoyu Hu, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Catherine Bollard

Stay on Your Current Meds

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people over 12 with certain types of lymphoma that have come back or didn't respond to treatment. They should not be pregnant, have HIV, or had a solid organ transplant. Participants need a minimum level of physical ability and blood cell counts, haven't used some therapies recently, and agree to use birth control.

Inclusion Criteria

I have mild side effects from Nivolumab, manageable with treatment.

Failure to meet institutional guidelines for treatment with Nivolumab

You have Hodgkin's lymphoma.

+33 more

Exclusion Criteria

I do not have any infections that are not responding to treatment.

I have mild or noticeable side effects from previous treatments.

You have received any experimental treatments within 28 days before being screened for this study.

Participant Groups

The study tests TAA-T cells combined with the PD-1 inhibitor Nivolumab in two groups: those with measurable disease after relapse (Group A) and as additional therapy post-stem cell transplant for high-risk patients (Group B). It aims to assess safety and potential benefits against lymphoma.

1Treatment groups

Experimental Treatment

Group I: Nivolumab with TAA-T cellExperimental Treatment2 Interventions

Patients will receive doses of Nivolumab at a minimum of 8 weeks prior to first TAA-T cell infusion and additional dose(s) of Nivolumab will be given after 4 weeks following second TAA-T cell infusion starting at week 7 from first infusion of TAA-T.If patient meets eligibility criteria for TAA-T cell infusion, the patient will receive two TAA-T cell infusions given 2 weeks apart

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: