Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Infections

Heart and Blood Diseases

Rare Diseases

Recurrence

Leukemia

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Burkitt Lymphoma

Waldenstrom Macroglobulinemia

Leukemia, Hairy Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphoma, Non-Hodgkin

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

B-cell Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Hairy Cell Leukemia

18-34 participants with FL will be administered the RP2D of CD22CART

12-32 participants with MCL will be administered the RP2D of CD22CART.

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.

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.

CD22CART Infusion

Kelly Chyan

Kendall Levine

Matthew Frank, MD

Matthew Frank, MD, PhD

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.

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

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.

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.

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)

Evaluate Progression Free Survival (PFS) in adults with relapsed/refractory B cell lymphoma after receiving CD22CART. PFS defined as the interval from CD22CART infusion to time of disease progression or death from any cause

Evaluate Overall Survival (OS) in adults with relapsed/refractory B cell lymphoma after receiving CD22CART. OS defined as the interval from CD22CART infusion to the time of death from any cause.

Evaluate Duration of Response (DOR) in adults with relapsed/refractory B cell lymphoma after receiving CD22CART. DOR defined as the interval from achieving an objective response to the time of disease progression.

Describe the response rates assessed at 3 months post CD22 CART infusion for Cohort 3 (HCL, WM, BL, and MZL).

The Leukemia and Lymphoma Society

Stanford University

Spots Global Cancer Trial Database for AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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