NCT04088890

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Matthew Frank · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• B-ALL
• B-cell Non Hodgkin Lymphoma
• DLBCL
• Follicular Lymphoma Grade 3B

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine 30 mg/m2
DRUG	Cyclophosphamide	Cyclophosphamide 500 mg/m2
DRUG	CD22 CAR	Autologous T cells transduced with lentiviral vector (CD22.BB.Z) Chimeric Antigen Receptor (CD22 CAR). Autologous CD22 CAR T cells will be administered intravenously at Dose Level 1 in subjects with ALL. Autologous CD22-CAR T cells will be administered in 3 escalating doses (Dose Level 1, 2, and 3) in subjects with aggressive B-cell NHL to determine MTD/RP2D

Timeline

• Start date: 2019-09-12
• Primary completion: 2024-11-07
• Completion: 2025-03-07
• First posted: 2019-09-13
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study