CAR T Cells for Lymphoma

Phase 1

Recruiting

Led By Matthew Frank, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of CD22CART treatment in adults with relapsed or refractory B Cell Lymphomas. They will follow participants to see how long they survive, how

Who is the study for?

This trial is for adults with certain types of B Cell Lymphomas that have come back or haven't responded to treatment. Participants must have tried at least two prior therapies, including one with an anti-CD20 monoclonal antibody and chemotherapy. They should not be eligible if they've had fewer than two previous lines of therapy or don't meet specific disease progression criteria.

What is being tested?

The trial tests CD22CART Infusion after lymphodepleting chemotherapy in patients with relapsed/refractory B Cell Lymphomas. It aims to assess the safety and effectiveness by tracking overall survival, progression-free survival, and duration of response post-treatment.

What are the potential side effects?

Potential side effects may include reactions related to the infusion process, immune system complications due to CAR T-cell activity against cancer cells, as well as general symptoms like fatigue, fever, or chills from the body's response to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort.

Determine the overall response rate (ORR) in adults with follicular lymphoma (FL) and mantle cell lymphoma (MCL)

Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D)

Secondary study objectives

Assess the response rate in adults with relapsed/refractory Hairy cell leukemia (HCL), Lymphoplasmacytic lymphoma (Waldenstrom macroglobulemia) (WM), Burkitt lymphoma (BL), and Marginal Zone lymphoma (MZL).

Evaluate Duration of Response (DOR)

Evaluate Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Other lymphomasExperimental Treatment1 Intervention

up to 30 participants with no more than 10 of any one type, including: Hairy cell leukemia, Lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia), Burkitt lymphoma, and Marginal zone lymphoma.

Group II: Cohort 2: Mantle cell lymphoma (MCL)Experimental Treatment1 Intervention

12-32 participants with MCL will be administered the RP2D of CD22CART.

Group III: Cohort 1: Follicular lymphoma (FL)Experimental Treatment1 Intervention

18-34 participants with FL will be administered the RP2D of CD22CART

Do I qualify?Apply below to find out