Clinical trial · Interventional
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
NCT06870279CI-TRIAL-00088892not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CGC738 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-NKT Cells Lymphodepleting regimen
- description
- CAR-NKT Cells treatment
- interventionNames
- Drug: CGC738
Primary outcomes (1)
- measure
- Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)
- timeFrame
- Day 28 after CGC738 infusion
- description
- 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.
Secondary outcomes (3)
- measure
- ORR
- timeFrame
- Day 1 through week 56
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.