Clinical trial NCT06870279: A Clinical Research of CD70-targeted CAR-NKT Cells (CGC738) Therapy in RCC
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Clear Cell Renal Cell Carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
timeFrame: Day 28 after CGC738 infusion
Secondary outcomes:
measure: ORR
timeFrame: Day 1 through week 56
measure: DCR
timeFrame: Day 1 through week 56
measure: AEs
timeFrame: Day 1 through week 56
Other outcomes:
Locations:
Study officials:
References: