CD22 CART for Relapsed/Refractory B Cell Lymphomas

This study is testing a treatment called CD22CART for adults with certain types of B cell lymphomas that have come back or not responded to previous treatments. These include Follicular Lymphoma, Mantle Cell Lymphoma, Hairy Cell Leukemia, Lymphoplasmacytic Lymphoma, and Burkitt Lymphoma. You might be able to join if you've had at least two lines of systemic therapy, including an anti-CD20 monoclonal antibody. The researchers want to see if CD22CART can be successfully made and if it helps shrink the cancer (overall response rate). They are also looking at the highest safe dose. The study plans to enroll 148 participants, but its current status is unclear.

Study design
This is an interventional, non-randomized clinical trial. It aims to enroll 148 participants.
What's involved
You would be hospitalized to receive the CD22CART infusion for about 5 to 7 days, or until side effects improve.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for overall survival, progression-free survival, and duration of response. Manufacturing feasibility and maximum tolerated dose will be assessed at 6 years, and overall response rate at 3 months after infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06340737

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Stanford University
~148 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:CD22CART Infusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort.
Measured over 6 years
+2 more outcomes measured
Follicular Lymphoma
Mantle Cell Lymphoma
Hairy Cell Leukemia
Lymphoplasmacytic Lymphoma
Burkitt Lymphoma
Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Large B-cell Lymphoma
1 sites across 1 states
California1
  • Matthew Frank, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Disease: Must have histologically confirmed disease as defined by WHO 2016\[117\] of one of the following:
Subjects with transformed FL and MZL who HAVE received anthracycline-containing chemotherapy prior to transformation must have progressed, had SD or recurred with transformed disease after initial treatment for LBCL:
Platelet count ≥ 50,000/uL
ALC ≥ 150/uL
Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine \< 2 mg/dL OR Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL/min, Serum ALT or AST ≤ 10 x ULN (except in participants with liver involvement by lymphoma), Total bilirubin ≤ 1.5 mg/dl, except in participants with Gilbert's syndrome, Cardiac left ventricular ejection fraction ≥ 45%, no evidence of clinically significant pericardial effusion as determined by an Echocardiogram.
No clinically significant pleural effusion or ascites
Baseline oxygen saturation \> 92% on room air ANC Platelet ALC Cr CreatCl AST/ALT Bilirubin LVEF O2 Sat
11\. Participants with CNS involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity 12. Females of childbearing potential must have negative pregnancy test. 13. Females of child-bearing potential and males of child-fathering potential must be willing to practice birth control from time of enrollment and for 4 months post preparative lymphodepletion regimen or as long as CAR cells are detectable.

Exclusion

Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.
  • Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort.6 years

    Rate of successful manufacture of CD22CART cells at the target dose level that meet required release specifications in Cohort 1, Cohort 2, and Cohort 3.

  • Maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D)6 years

    Establish the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of CD22CART cells in 3 cohorts of adults with relapsed/refractory B Cell lymphoma.

  • Determine the overall response rate (ORR) in adults with follicular lymphoma (FL) and mantle cell lymphoma (MCL)3 months CD22 CART infusion

    Assess the ORR at 3 months post CD22 CART infusion as defined by the disease specific response criteria for Cohort 1 (FL) and Cohort 2 (MCL)