NCT03019055

Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell

Phase 1/1b Study of Redirected Autologous T Cells Engineered to Contain an Anti CD19 and Anti CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed and/or Refractory CD19 or CD20 Positive B Cell Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragment (scFv) coupled to cluster of differentiation CD3ζ (CD3ζ) and co-stimulatory domain 4-1BB (4-1BB) signaling domains in patients with relapsed and/or refractory CD19 or CD20 positive B cell malignancies

Detailed description

This is a single center, single arm, open label phase I/1b study to demonstrate the feasibility of manufacturing CAR-T cells expressing tandem receptors against both CD20 and CD19 (CAR-20/19-T) in a completely closed system using the CliniMACS Prodigy device and then determine the safety of this dual targeted CAR in a first-in-human study of patients with relapsed and refractory B cell malignancies. Secondary outcomes will include response rates, and observed toxicities of the treatment, specifically the development of cytokine release syndrome (CRS), an inflammatory storm that has been seen with previous CAR-T therapies.

Conditions

• Lymphoma, Non-Hodgkin
• Lymphoma, B-Cell
• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg)	CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Phase 1 Dose Level 0: 2.5 x10\^5 CAR-20/19-T cells/kg (starting dose level)
BIOLOGICAL	CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)	CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Phase 1 Dose Level 1: 7.5 x10\^5 CAR-20/19-T cells/kg
BIOLOGICAL	CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)	CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection. Phase 1 Dose Level 2: 2.5 x10\^6 CAR-20/19-T cells/kg (goal cell dose) Phase 1b Expansion Dose Level: 2.5 x 10\^6 cells/kg (single infusion)
BIOLOGICAL	CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)	CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.

Timeline

• Start date: 2017-10-16
• Primary completion: 2019-10-01
• Completion: 2021-08-24
• First posted: 2017-01-12
• Last updated: 2023-07-27
• Results posted: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study