Spots Global Cancer Trial Database for Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies

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Trial Identification

Brief Title: Autologous CD22 CAR T Cells in Adults w/ Recurrent or Refractory B Cell Malignancies

Official Title: Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Adults With Recurrent or Refractory B Cell Malignancies

Study ID: NCT04088890

Conditions

B-ALL

B-cell Non Hodgkin Lymphoma

DLBCL

Follicular Lymphoma Grade 3B

Interventions

Fludarabine

Cyclophosphamide

CD22 CAR

Study Description

Brief Summary: The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from adults with relapsed/refractory B-cell malignancies (leukemia and lymphoma).

Detailed Description: Primary Objective: * Determine the feasibility of manufacturing CD22 CAR T cells using the Miltenyi CliniMACS Prodigy® system for administration to adults with relapsed/refractory CD22 expressing B-cell ALL or relapsed/refractory aggressive B-cell non hodgkins lymphoma (NHL). * Establish the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of CD22 CAR T cells in adults with relapsed/refractory aggressive B-cell NHL. * Determine the safety of an established dose of CD22-CAR T cells in adults with relapsed/refractory CD22 expressing B-cell ALL and the safety of the MTD/RP2D of CD22-CAR T cells in adults with relapsed/refractory aggressive B-cell NHL. Secondary Objective: - Assess the clinical activity of CD22-CAR T cells in adults with R/R CD22 expressing B-cell ALL and R/R aggressive B-cell NHL, including overall survival (OS) and progressive free survival (PFS).