A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC

NCT06870279 | Not Yet Recruiting Phase 1

• 1 other identifier: CGC738-IIT-02
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC738 in the treatment of advanced clear cell renal cell carcinoma (ccRCC).

Conditions

Advanced Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)

  Dose limiting toxicity (DLT) is an AE that meets the following criteria and occurs within 28 days of CGC738 infusion.AE is graded according to CTCAE version 5.0.

  Day 28 after CGC738 infusion

Secondary Outcomes (3)

• ORR

  Day 1 through week 56

• DCR

  Day 1 through week 56

• AEs

  Day 1 through week 56

Study Arms (1)

CAR-NKT Cells Lymphodepleting regimen

EXPERIMENTAL

CAR-NKT Cells treatment

Drug: CGC738

Interventions

CGC738 DRUG

CAR-NKT Cells treatment

CAR-NKT Cells Lymphodepleting regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18 to 75 years.
• ECOG 0-1 points.
• \. The expected survival time is more than 3 months.
• \. Patients with advanced ccRCC confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment.
• \. IHC: CD70 positive.
• \. At least one measurable lesion at baseline per RECIST version 1.1.
• \. The functions of important organs are basically normal:
• \. Pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception.

You may not qualify if:

• \. Use of cell therapy within the previous one month.
• \. Subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment.
• \. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
• \. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
• \. Active hepatitis B, HIV positive and HCV positive.
• \. Active infection or uncontrollable infection.
• \. Uncontrollable or significant heart disease.
• \. Unstable respiratory diseases, including interstitial pneumonia.
• \. Uncontrolled ascites and pleural effusion.
• Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc.
• Subjects who are using systemic steroids or steroid inhalers for treatment.
• Pregnant or lactating female subjects.
• Other investigators deem it unsuitable to participate in the study

Sponsors & Collaborators

• RenJi Hospital: lead

Central Study Contacts

Zhai Wei

CONTACT

+8618701771959; jackyzw2007@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: May 25, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04