NCT05110742

Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.

Detailed description

Primary objective: To determine the safety, tolerability and optimal cell dose of iC9/CD5CAR/IL-15 NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases. Secondary Objectives: * To assess the overall response rate (complete and partial response rates) * To quantify persistence of infused allogeneic donor iC9/CD5CAR/IL-15 NK cells in the recipient. * To conduct comprehensive immune reconstitution studies.

Conditions

• Hematological Malignancy

Interventions

Type	Name	Description
DRUG	Fludarabine Phosphate	Given by IV
DRUG	Cyclophosphamide	Given by IV
DRUG	CAR.5/IL15-transduced CB-NK cells	Given by IV

Timeline

• Start date: 2024-04-22
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2021-11-08
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study