19(T2)28z1xx Chimeric Antigen Receptor (CAR) T Cells in People With B-Cell Cancers

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Burkitt's Lymphoma
Chronic Lymphocytic Leukemia
Diffuse Large B Cell Lymphoma
Indolent Non Hodgkin Lymphoma
Marginal Zone Lymphoma
Primary CNS Lymphoma
Primary Mediastinal Large B Cell Lymphoma
Transformed Follicular Lymphoma to Diffuse Large B Cell Lymphoma
Waldenstrom Macroglobulinemia

Type

Interventional

Phase

Phase 1

Design

Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: This is a standard phase I open-label dose-escalation trial. Cohorts of 3-6 patients will be infused with escalating doses of 19(T2)28z1XX CAR T cells to establish the MTD. There are 5 planned dose levels with one additional de-escalation dose level. A 3+3 design will be used to establish the RP2D. Once the RP2D is determined, the study will open to Dose Expansion phase with two cohorts. Cohort 1 will comprise of up to 12 patients with B-cell non-Hodgkin lymphoma (same eligibility criteria as the dose-escalation phase). Cohort 2 will include up to 12 patients with other CD19+ B cell hematologic malignancies including CLL, indolent B-cell lymphoma, primary CNS lymphoma, and Richter's transformation.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

Not Provided

Tracking Information

NCT #: NCT04464200
Collaborators: Takeda
Investigators: Principal Investigator: Jae Park, MD Memorial Sloan Kettering Cancer Center