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CAR T-cell Therapy

CAR T-cell Therapy for Non-Hodgkin Lymphoma

Phase 1

Recruiting

Led By Matthew Frigault, MD

Research Sponsored by Marcela V. Maus, M.D.,Ph.D.

Eligibility Criteria Checklist

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

Must have

≥18 years of age at the time of signing informed consent

- Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and grade 3b Follicular Lymphoma (FL). - R/R disease after 2 or more prior lines of therapy OR - Relapsed following autologous SCT, OR - Ineligible for autologous SCT.

Must not have

Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.

Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 0 to 2 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the use of CAR T cells to treat people with advanced Non-Hodgkin Lymphoma that has relapsed or not responded to treatment.

Who is the study for?

This trial is for adults over 18 with certain types of Non-Hodgkin Lymphoma that have relapsed or are not responding to treatment. They must have had specific prior therapies, be in a stable condition without severe infections or heart problems, and not be pregnant. Participants should also agree to use contraception.

What is being tested?

The study tests CD79b-19 CAR T cells in patients with Non-Hodgkin Lymphoma who haven't responded well to other treatments. It includes standard chemotherapy drugs cyclophosphamide and fludarabine used in the lymphodepleting process before administering the CAR T cells.

What are the potential side effects?

Possible side effects include immune system reactions, fever, fatigue, difficulty breathing, changes in blood pressure or heart rate during infusion; there may also be risks related to chemotherapy such as nausea and low blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have a specific type of lymphoma and it has returned or not responded after at least 2 treatments.

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I am mostly self-sufficient and can carry out daily activities.

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My Marginal Zone Lymphoma has not improved after at least 2 treatments.

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My follicular lymphoma has returned or resisted treatment after 2+ therapies.

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My condition is relapsed or refractory mantle cell lymphoma.

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I have been treated with anthracycline or bendamustine, anti-CD20 therapy, and BTKi therapy.

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My kidneys work well, with a creatinine clearance over 60 ml/min.

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My liver tests are within normal limits.

Exclusion Criteria

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

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I have a history of severe heart failure or non-ischemic cardiomyopathy.

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I am currently on long-term immune system suppressing drugs.

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I am on immunosuppressants due to GVH from a bone marrow transplant over 12 weeks ago.

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I have a history of stroke or blood vessel disease and need blood thinners.

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I have been treated with a therapy that targets EGFR before.

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I have had CD19-directed cellular therapy before.

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I have an active brain or spinal cord disease.

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I am not pregnant or breastfeeding.

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I do not have any ongoing serious infections.

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I haven't had cancer treatment in the last week, except for low-dose steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 0 to 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 0 to 2 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 0 to 2 years post-treatment 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 Dose Limiting Toxicity (DLT)

Incidence of adverse events (AEs)

Secondary study objectives

Overall Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

Awards & Highlights

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: CD79b-19 CAR T cellsExperimental Treatment3 Interventions

Prior to receiving CD79b-19 CAR T cells, participants will undergo two preparatory processes: * Leukapheresis: During Week -3 white blood cells will be collected. * Lymphodepletion: On days, -5 to -3 participants will receive 3 days of chemotherapy to decrease the number of lymphocytes CD79b-19 CAR T cells will be administered intravenously on day 0 only. The dose you will receive will depend on the number of participants who have been enrolled prior and how well the dose was tolerated. The CD79b-19 CAR T cells will be administered over approximately 1 hour.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860