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Not yet recruiting NCT06870279

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

Phase I Interventional Advanced Clear Cell Renal Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CGC738.
Who it may be relevant to
Registry conditions: Advanced Clear Cell Renal Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug CGC738
    CAR-NKT Cells treatment

Primary outcome measures

  • Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) [Time frame: Day 28 after CGC738 infusion]
Secondary outcome measures (3)
  • ORR [Time frame: Day 1 through week 56]
  • DCR [Time frame: Day 1 through week 56]
  • AEs [Time frame: Day 1 through week 56]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06870279 · CGC738-IIT-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗