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CAR T-cell Therapy
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,518,949 Total Patients Enrolled
1 Trials studying Waldenstrom Macroglobulinemia
3 Patients Enrolled for Waldenstrom Macroglobulinemia
The Leukemia and Lymphoma SocietyOTHER
85 Previous Clinical Trials
26,044 Total Patients Enrolled
3 Trials studying Waldenstrom Macroglobulinemia
10,161 Patients Enrolled for Waldenstrom Macroglobulinemia
Matthew Frank, MD, PhDPrincipal InvestigatorStanford University
1 Previous Clinical Trials
52 Total Patients Enrolled