NCT07072234

Phase I Study of Allogeneic Transforming Growth Factor-beta Receptor Type 2 Knockout CD70 CAR NK Cells in Treatment Refractory Clear Cell Renal Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Testing an investigational cancer therapy called TGFBR-2 KO CD70 CAR NK cell therapy.

Detailed description

Primary Objective • To determine the safety, tolerability, maximum tolerated dose (MTD), and optimal celldose (OCD) of chimeric antigen receptor TGFBR-2 KO CD70 CAR NK cells in participants with advanced ccRCC. Secondary Objectives • To determine the antitumor activity of TGFBR-2 KO CD70 CAR NK cells. Although the clinical benefit of TGFBR-2 KO CD70 CAR NK cells has not yet been established in ccRCC, the intent of offering this treatment is to provide a possible therapeutic benefit and thus, the participants will be carefully monitored for tumor response and symptom relief in addition to safety and tolerability.

Conditions

• Clear Cell Carcinoma
• Phase 1
• Growth Factor

Interventions

Type	Name	Description
DRUG	Lymphodepleting chemotherapy	Given by IV
DRUG	Dexamethasone	Given PO
DRUG	Fludarabine	Given by IV
DRUG	Cyclophosphamate	Given by IV
DRUG	TGFBR-2 KO CD70 CAR NK	Given by IV

Timeline

• Start date: 2025-09-25
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2025-07-18
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study