A Phase 1 interventional study of CGC738 in Advanced Clear Cell Renal Cell Carcinoma, sponsored by RenJi Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by RenJi Hospital · Phase 1, Interventional, and Treatment
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).
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 28 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CAR-NKT Cells treatment
Drug: CGC738
CAR-NKT Cells treatment
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.
Time frame: Day 28 after CGC738 infusion
ORR
Assess Objective response rate
Time frame: Day 1 through week 56
DCR
Assess Disease control rate
Time frame: Day 1 through week 56
AEs
Incidence of adverse events
Time frame: Day 1 through week 56
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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RenJi Hospital