Actively Recruiting
Phase Ib Clinical Trial of Autologous CD22 CAR T Cells in Adults With Recurrent or Refractory B Cell Lymphomas
Led by Stanford University · Updated on 2025-08-07
148
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
T
The Leukemia and Lymphoma Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CD22CART, a type of autologous chimeric antigen receptor T cell therapy, in adults with relapsed or refractory B Cell Lymphomas. This phase 1, non-randomized clinical trial focuses on patients with various lymphoma types, including follicular lymphoma, mantle cell lymphoma, and others. The study aims to assess overall survival, progression-free survival, and duration of response among participants who complete leukapheresis, chemotherapy, and CART infusion. Participants receive lymphodepleting chemotherapy followed by an infusion of CD22CART. The treatment requires hospitalization for about 5 to 7 days. Four cohorts with different lymphoma types will receive the recommended phase 2 dose of CD22CART, including follicular lymphoma, mantle cell lymphoma, hairy cell leukemia, lymphoplasmacytic lymphoma, Burkitt lymphoma, marginal zone lymphoma, and large B-cell lymphoma. The study monitors dose levels, overall response rates, and tolerability during the treatment period. During the study, participants undergo various assessments including measuring disease response, survival rates, and adverse events. Tissue samples will be analyzed for CD22 expression, and participants will be monitored for organ function and performance status. Follow-up continues for up to six years to evaluate long-term outcomes such as progression free survival and overall survival. Women of childbearing potential and men must use birth control during the study and for four months afterward. Participants must be able to provide informed consent or assent.
CONDITIONS
Brief Title
AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed diagnosis of follicular lymphoma (grade 1-3a), mantle cell lymphoma, hairy cell leukemia, lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia), Burkitt lymphoma, marginal zone lymphoma, or large B-cell lymphoma
- Relapsed or refractory disease after at least 2 lines of systemic therapy including an anti-CD20 monoclonal antibody (exceptions apply for CD20 negative disease)
- Measurable disease according to lymphoma response criteria or disease presence by flow cytometry in blood or marrow
- Availability of tissue for CD22 expression analysis or willingness to undergo biopsy
- At least 100 days post prior stem cell transplant with no graft-versus-host disease and off immunosuppressants for at least 30 days
- Stable or resolved toxicities from prior therapy
- Adequate performance status and organ function
- Negative pregnancy test for females of childbearing potential
- Willingness to use birth control during and 4 months after treatment
- Ability to provide informed consent or assent
You will not qualify if you...
- Rapidly progressive disease that would prevent completing study therapy
- History or current other malignancies except certain treated or low-risk cancers
- Active infections requiring intravenous antimicrobials
- Ongoing HIV, hepatitis B, or hepatitis C infection (unless viral load undetectable)
- Active central nervous system diseases impairing neurological assessment
- Recent serious cardiac events within 12 months
- Severe allergic reactions to similar compounds
- Pregnant or breastfeeding
- Active primary immunodeficiency or autoimmune disease requiring recent systemic immunosuppression
- Medical conditions likely to interfere with study safety or completion of protocol visits and procedures
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants receive a CD22CART infusion and are hospitalized for approximately 5 to 7 (±2) days to monitor and manage any side effects.
1 hospitalization visit and follow-up assessments
Duration - Up to 6 years
Participants are monitored for response and safety following treatment.
Regular follow-up visits over several years
Trial Site Locations
Total: 1 location
1
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
K
Kelly Chyan
K
Kendall Levine
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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