NCT07335328

Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

Phase 1 Study of a Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.

Detailed description

The purpose of this study is to determine the safety of fully human lentiviral 20.19 (h20.19) CAR T cells in patients with relapsed, refractory B-cell malignancies. A maximum of 12 patients will be treated in the Phase 1 cohort followed by a 12-patient expansion cohort (approximately 21 to 24 patients total).

Conditions

• B-cell Non Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	1 X 10^6 cells/kg	Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
BIOLOGICAL	2.5 X 10^6 cells/kg	Dose escalation: CAR-T cells will be administered at one of two dose levels either fresh or thawed after cryopreservation by IV injection.
BIOLOGICAL	Dose expansion: The maximum tolerated dose of CAR-T cells	Dose expansion: The maximum tolerated dose intervention will be updated when it is determined. It will be one of two doses: 1 X 10\^6 cells/kg or 2.5 X 10\^6 cells/kg.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2031-05-01
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study