NCT07137481

Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety and efficacy (1-year PFS) of iC9/CD5CAR/IL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission.

Detailed description

Primary Objective: To determine the safety and efficacy (1-year PFS) of iC9/CD5CAR/IL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission. Secondary Objectives: To assess overall survival at 1 year. To quantify persistence of infused allogeneic donor iC9/CD5CAR/IL-15 NK cells in the recipient. To conduct comprehensive immune reconstitution studies. To establish the safety of this treatment.

Conditions

• Hematological Malignancies

Interventions

Type	Name	Description
DRUG	C9/CD5CAR/IL-15 NK cells	Given PO or IV
DRUG	Rituximab	Given by IV
DRUG	Fludarabine	Given by IV
DRUG	Cyclophosphamide	Given by IV

Timeline

• Start date: 2027-02-28
• Primary completion: 2030-07-31
• Completion: 2032-07-31
• First posted: 2025-08-22
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study