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

A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects With Advanced Clear Cell Renal Cell Carcinoma

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Clear Cell Renal Cell Carcinoma
• Intervention / Treatment: Drug: CGC738

Detailed Description

This is a single-arm, open-label study. This study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by CAR-T cell injection.

Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-CD70 CAR-T cell injection.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhai Wei; Phone Number: +8618701771959; Email: jackyzw2007@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 1. Use of cell therapy within the previous one month.
• 2. 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.
• 3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
• 4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
• 5. Active hepatitis B, HIV positive and HCV positive.
• 6. Active infection or uncontrollable infection.
• 7. Uncontrollable or significant heart disease.
• 8. Unstable respiratory diseases, including interstitial pneumonia.
• 9. Uncontrolled ascites and pleural effusion.
• 10.Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc.
• 11.Subjects who are using systemic steroids or steroid inhalers for treatment.
• 12.Pregnant or lactating female subjects.
• 13.Other investigators deem it unsuitable to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CAR-NKT Cells Lymphodepleting regimen; CAR-NKT Cells treatment	Drug: CGC738; CAR-NKT Cells treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Assess Objective response rate	Day 1 through week 56
DCR	Assess Disease control rate	Day 1 through week 56
AEs	Incidence of adverse events	Day 1 through week 56

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 5, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 19, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Kidney Neoplasms; Carcinoma; Carcinoma, Renal Cell
• Other Study ID Numbers: CGC738-IIT-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No