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CAR T-cell Therapy

Cohort 2: Mantle cell lymphoma (MCL) for Burkitt 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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,230 Total Patients Enrolled

1 Trials studying Burkitt Lymphoma

3 Patients Enrolled for Burkitt Lymphoma

The Leukemia and Lymphoma SocietyOTHER

82 Previous Clinical Trials

17,011 Total Patients Enrolled

Matthew Frank, MD, PhDPrincipal InvestigatorStanford University

1 Previous Clinical Trials

52 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cohort 1, which focuses on treating follicular lymphoma (FL), received approval from the Food and Drug Administration (FDA)?

"Our team at Power rated the safety of Cohort 1: Follicular lymphoma (FL) as a level 1 on our scale. This decision is based on the fact that this trial is in Phase 1, indicating limited evidence supporting both safety and efficacy."

Answered by AI

What is the main objective of this clinical trial?

"The primary aim of this investigation, projected to span about 6 years, is to determine the Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D). Additional goals involve Assessing Progression Free Survival (PFS) characterized as Evaluating PFS in adult patients with relapsed/refractory B cell lymphoma post-receipt of CD22CART. PFS is delineated as the period from CD22CART infusion to disease progression or death from any cause; Analyzing Overall Survival (OS) described as Reviewing OS in adult patients with relapsed/refractory B cell lymphoma post-CD"

Answered by AI

Are there any available openings for patients to participate in this medical study?

"According to the information provided on clinicaltrials.gov, this research study is actively seeking participants. The trial was initially made available on March 29th, 2024 and underwent its most recent update on April 1st of the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas

2024. "AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06340737.

All > Waldenstrom Macroglobulinemia > Hairy Cell Leukemia