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AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Lymphomas

NCT06340737•Stanford University

View on ClinicalTrials.gov

Summary

This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR). An evaluable participant is one who completes leukapheresis, lymphodepleting chemotherapy and CART infusion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Disease: Must have histologically confirmed disease as defined by WHO 2016\[117\] of one of the following:
•Follicular Lymphoma, grade 1-3a
•1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not count as line of therapy for eligibility nor does local radiation). Anti-CD20 antibody is not required for participants with CD20 negative disease. A systemic therapy includes, but is not limited to: Bendamustine, CHOP, CVP, CART therapy, lenalidomide, or platinum-based chemotherapy.
•Mantle Cell Lymphoma 1. Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy. Anti-CD20 antibody is not required for participants with CD20negative disease.
•2\. Participants who have received an anti-CD20 monoclonal antibody in combination with chemotherapy AND a Bruton's Tyrosine Kinase inhibitor as a single line of therapy are also eligible.
•Hairy cell leukemia (HCL)
•1. Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \<11 g/dL), thrombocytopenia (platelets\<100 x 10\^9 /L), or neutropenia (absolute neutrophil count below 1.5 x 10\^9/L); symptomatic splenomegaly or adenopathy; or other constitutional symptoms directly related to HCL;
•2. Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog.
•Lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia (WM)) - participants must meet all eligibility criteria listed
•1\. Must have confirmed diagnosis of WM based on Second International Workshop on WM 2. Relapsed or refractory disease after 2 or more lines of therapy
+23 more criteria

Exclusion Criteria

•The following criteria apply to all participants unless otherwise noted:
•2\. Measurable Disease:
•1. a. Participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma and Marginal Zone Lymphoma must have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
•b. If participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma, Marginal Zone Lymphoma, and Large B cell Lymphoma that do not have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma, but have disease that is greater than 2% of events by flow cytometry in the peripheral blood or bone marrow will be eligible
•2. c. Participants with Hairy Cell Lymphoma must have presence of leukemic cells in the bone marrow or blood stream.
•3. d. Participants with Lymphoplasmacytic lymphoma must have the presence of serum IgM that is at least 2 times the upper limit of normal.
•3\. CD22 expression, at any level: Participants must have archival tissue available for analysis of CD22 expression or must be willing to undergo biopsy of easily accessible disease.
•4\. Participants who have progressed or relapsed after prior autologous OR allogeneic SCT must be at least 100 days post-transplant, have no evidence of GVHD, and have been without immunosuppressive drugs at least 30 days.
•Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.
•2\. History or current other malignancies, apart from non-melanoma skin cancer, low-grade untreated prostate cancer under observation, or carcinoma in situ, unless disease free for at least 3 years, or in remission 1-2 years and Principal Investigator assesses other malignancy as unlikely to return within 1 year or interfere with CAR T cell safety
+8 more criteria

Locations (1)

Stanford University

Palo Alto, California, United States

Key Dates

Start Date

March 29, 2024

Primary Completion Date

April 1, 2031

Completion Date

April 1, 2031

Last Updated

August 7, 2025

Enrollment

148

ESTIMATED participants

Conditions

Follicular LymphomaMantle Cell LymphomaHairy Cell LeukemiaLymphoplasmacytic LymphomaBurkitt LymphomaMarginal Zone LymphomaWaldenstrom MacroglobulinemiaLarge B-cell Lymphoma

Interventions

CD22CART Infusion

DRUG

Contacts

Kelly Chyan

CONTACT

650-625-8130 kchyan@stanford.edu

Kendall Levine

CONTACT

650-604-7104 klevine@stanford.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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