NCT05703854

Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma

Phase I/II Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To find a recommended dose of donated NK cells that can be given with lymphodepleting chemotherapy to patients with advanced renal cell carcinoma, mesothelioma, or osteosarcoma. The effects of this therapy will also be studied.

Detailed description

Primary Objective: * To determine the safety, tolerability, and optimal cell dose of chimeric antigen receptor (CAR).70/interleukin (IL)15-transduced cord blood (CB)-derived natural killer (NK) cells in patients with advanced renal cell carcinoma, advanced mesothelioma, and advanced osteosarcoma. * To determine the antitumor activity of CAR.70/IL15-transduced CB-derived NK cells. Although the clinical benefit of CAR.70/IL15-transduced CB-derived NK cells has not yet been established, the intent of offering this treatment is to provide a possible therapeutic benefit and thus, the patient will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability. Efficacy will be determined in each of the three cohorts. Secondary Objectives: * To quantify the persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient. * To conduct comprehensive immune reconstitution studies. * To obtain preliminary data on quality of life and patient experience.

Conditions

• Advanced Renal Cell Carcinoma
• Advanced Mesothelioma
• Advanced Osteosarcoma

Interventions

Type	Name	Description
DRUG	CAR.70/IL15-transduced CB-derived NK cells	Given by IV (vein)
DRUG	Fludarabine phosphate	Given by IV (vein)
DRUG	Cyclophosphamide	Given by IV (vein)

Timeline

• Start date: 2023-03-29
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2023-01-30
• Last updated: 2026-03-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study