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Not yet recruitingNCT06870279Updated Apr 24, 2025

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Advanced Clear Cell Renal Cell Carcinoma
03

In context

Carcinoma

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

    1. Use of cell therapy within the previous one month.
    1. 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.
    1. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms.
    1. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
    1. Active hepatitis B, HIV positive and HCV positive.
    1. Active infection or uncontrollable infection.
    1. Uncontrollable or significant heart disease.
    1. Unstable respiratory diseases, including interstitial pneumonia.
    1. 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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    CAR-NKT Cells Lymphodepleting regimen

    CAR-NKT Cells treatment

    Drug: CGC738

Interventions

  • DrugCGC738

    CAR-NKT Cells treatment

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. ORR

    Assess Objective response rate

    Time frame: Day 1 through week 56

  2. DCR

    Assess Disease control rate

    Time frame: Day 1 through week 56

  3. AEs

    Incidence of adverse events

    Time frame: Day 1 through week 56

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06870279
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Mar 11, 2025
Start date
May 25, 2025 (estimated)
Primary completion
Aug 1, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 24, 2025

Study contacts

Zhai Wei
Contact
jackyzw2007@163.com
+8618701771959

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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