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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06340737
Phase
PHASE1
Status
Recruiting
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Conditions

  • Burkitt Lymphoma
  • Follicular Lymphoma
  • Hairy Cell Leukemia
  • Large B-cell Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD22CART Infusion — DRUG
    Dosing and Administration Participants will be hospitalized to receive treatment with CD22CART, if not previously hospitalized, and will remain hospitalized for approximately 5 to 7 (±2) days. Patients may be discharged once all AEs have resolved to Grade 1 or better, or at the discretion of the treating physician. Participants may be discharged with non critical and clinically stable or slowly improving toxicities (e.g., renal insufficiency, cytopenias) even if \> Grade 1, if deemed appropriate by the investigator.

Study Details

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.

Key Dates

Start date
Mar 29, 2024
Status verified
Aug 2025
Primary completion
Apr 30, 2031
Completion
Apr 30, 2031

Study Design

Enrollment
148 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Follicular lymphoma (FL)
    18-34 participants with FL will be administered the RP2D of CD22CART
  • Experimental: Cohort 2: Mantle cell lymphoma (MCL)
    12-32 participants with MCL will be administered the RP2D of CD22CART.
  • Experimental: Cohort 3: Other lymphomas
    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.
  • Experimental: Cohort 4: Relapsed/refractory large B cell lymphoma (LBCL)
    14 - 19 participants will be administered the RP2D of CD22 CART

Primary Outcome Measure

Determine the manufacturing feasibility of CD22 CART by assessing the target dose level and release specifications in each disease cohort. [ Time Frame: 6 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Kelly Chyan
[email protected]
650-625-8130
Matthew Frank, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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