NCT06879340

Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies

A Phase 1 Multicenter, Open Label Trial Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter phase 1 trial with "3 + 3" dose escalation design seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of chimeric antigen receptors targeting the B cell surface antigens CD19/20/22 following administration of a chemotherapy lymphodepletion regimen in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) or Non-Hodgkin's lymphoma (NHL). The overall goals of this study are to estimate maximum tolerated dose (MTD) level, establish the overall safety profile and evaluate initial efficacy of administering duo-CAR-T cell treatment in this patient population.

Detailed description

Dose Escalation Cohort (Phase 1) This will have 3 enrollment groups: Group A: Participants with B-ALL (CAR pre-treated or CAR naïve), Group B: Participants with B-NHL (CAR pre-treated), Group C: Participants with B-NHL (CAR naïve) The trial will begin with a phase I dose escalation evaluation in each of the three enrollment groups. Participants will be treated either at dose level 1 and dose level -1 or at dose level 1 and dose level 2 of CAR T cells. This phase will determine the MTD and /or RP2D for the subsequent Phase 2 study. The trial duration for an individual participant is 15 years from DUOCAR20.19.22-D95-CAR T cell infusion. Following infusion, DLT assessments will continue through end of Day 30 visit during Dose Escalation Phase 1. Efficacy and routine safety monitoring for Phase 1 cohort will occur at established protocol-defined intervals through Year 2 or until the start of a new treatment regimen, whichever occurs sooner. The observational long-term follow-up portion of the study will then become operative.

Conditions

• B-Cell Non-Hodgkin Lymphoma
• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	DuoCAR20.19.22-D95	Patient derived autologous T cells, lentiviral transduced to generate, using the Miltenyi CliniMACS Prodigy® closed transduction system, a Duo-CAR-T cells targeting cell surface antigens CD19/20/22.
DRUG	Fludarabine (Conditional therapy)	Lymphodepletion chemotherapy
DRUG	Cyclophosphamide (Conditional therapy)	Lymphodepletion chemotherapy

Timeline

• Start date: 2025-03-31
• Primary completion: 2030-03-01
• Completion: 2040-03-01
• First posted: 2025-03-17
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study