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PD-1 Inhibitor

TAA-T Cells + Nivolumab for Lymphoma

Phase 1

Waitlist Available

Led By Boyu Hu, MD

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Steroids less than 0.5 mg/kg/day prednisone or equivalent

Must not have

Uncontrolled infections

Patient with ≥ grade 1 or symptomatic non-hematologic toxicities from prior therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will enroll patients who have already tried other treatments and failed (group A) or who are at high risk of their lymphoma coming back after an autologous hematopoeitic stem cell transplant (group B).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune system reactions like inflammation in various organs, infusion-related reactions, changes in thyroid function which may require hormone replacement therapy, digestive enzyme abnormalities, and general symptoms such as fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have Hodgkin's lymphoma.

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I am taking less than 0.5 mg/kg/day of steroids.

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I have been treated with Nivolumab for at least 8 weeks.

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I need more than one treatment before my stem cell transplant for Hodgkin lymphoma.

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My condition relapsed within a year of diagnosis or within 6 months after finishing initial treatment.

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I have had a solid organ transplant.

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I have relapsed or unresponsive Hodgkin Lymphoma or Diffuse Large B-cell Lymphoma.

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I need more than one treatment before my stem cell transplant.

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I haven't achieved complete remission before my stem cell transplant.

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I am older than 12 years.

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I can do most activities but may need help.

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I've had 2 treatments fail, including stem cell and CAR T-cell therapies.

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I have DLBCL and am at high risk of relapse after a stem cell transplant.

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My Hodgkin lymphoma did not improve after at least one treatment, including Brentuximab Vedotin.

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My condition worsened or didn't improve after a stem cell transplant using my own cells.

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I can do most activities but may need help.

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I have had a bone marrow transplant from a donor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have mild or noticeable side effects from previous treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Product-Emergent Adverse Events

Secondary study objectives

Tumor response to combination immunotherapy

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

0 / 19Eligibility criteria met