CD70-targeted CAR-NKT Cells(CGC729) Therapy in the Renal Cell Carcinoma

Last updated: December 26, 2023
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

1

Condition

Renal Cell Carcinoma

Kidney Cancer

Carcinoma

Treatment

Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells

Clinical Study ID

NCT06182735
CGC729-IIT-01
  • Ages 18-75
  • All Genders

Study Summary

This is a phase I, open-label, single-arm study conducted to evaluate the safety, tolerability, PK, and preliminary efficacy of CGC729 with Relapsed or Metastatic advanced renal cell carcinoma.

Condition or disease:Renal Cell Carcinoma Intervention/treatment: Biological: CD70 CAR-NKT cells Phase 1

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects or their guardians agree to participate in this clinical trial and sign theICF, indicating that they understand the purpose and procedures of this clinical trialand are willing to participate in the research.
  2. Age 18 to 75 years.
  3. Patients with advanced clear cell renal cell carcinoma confirmed by histology orcytology to be recurrent or metastatic after at least second-line treatment.
  4. Archival and/or fresh tumor tissue samples are required.
  5. At least one measurable lesion at baseline per RECIST version 1.1.
  6. ECOG 0-1 points.
  7. The expected survival time is more than 12 weeks.
  8. The functions of important organs are basically normal: Hematopoietic function:neutrophils 1.5×109/L, platelets 75×109/L, hemoglobin 80g/L; Renal function:creatinine clearance of ≥60 mL/min.; Liver function: ALT and AST≤2.5×ULN (≤5 × ULN forpatients with liver metastases); Total bilirubin≤1.5×ULN. Coagulation INR < 1.7.
  9. Pregnancy tests for women of childbearing age shall be negative, Both men and womenagreed to use effective contraception.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating female subjects.
  2. Pregnant or lactating female subjects.
  3. Known positive test result for human immunodeficiency virus (HIV) oracquired immunedeficiency syndrome (AIDS).
  4. Active infection or uncontrollable infection.
  5. Known to have active or uncontrolled autoimmune diseases, such as Crohns disease,rheumatoid arthritis, systemic lupus erythematosus, etc. .
  6. Having a history of any mental illness, including dementia, altered mental status,which may affect informed consent and the understanding of the subject by the relevantquestionnaire.
  7. Have a serious uncontrollable illness that may affect the subject receiving treatmentfor this study.
  8. Subjects with other malignant tumors within the past 2 years, except basal or squamousskin cancer, superficial bladder cancer, and breast cancer in situ, have beencompletely cured and do not need follow-up treatment.
  9. Subjects who are using systemic steroids or steroid inhalers for treatment.
  10. Use of anti-CD70 therapy or cell therapy within the previous 3 months.
  11. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2weeks before cell infusion.
  12. Subjects allergic to immunotherapy or related drugs.
  13. Patients with leptomeningeal metastasis or central nervous system metastasis, anddefinite central nervous system underlying diseases with significant symptoms in thepast 6 months.
  14. Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standardtherapy requiring special treatment, previous history of myocarditis, or myocardialinfarction within 6 months.
  15. Earnestly received or organ transplantation or preparing to receive organ transplants.
  16. Other investigators deem it unsuitable to participate in the study.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells
Phase: 1
Study Start date:
July 17, 2023
Estimated Completion Date:
January 28, 2025

Study Description

Dose exploration for this study will be a 3+3 design with a target DLT rate of <1/3. A particular dose level will be expanded to 6 patients if one patient out of 3 patients treated at that particular dose level develops DLT. Once this occurs, further dose-escalations are halted until the dose has proven to be safe in the expanded cohort. If 2 or more in a cohort of 6 patients develop DLT no further dose escalation is allowed, and the next lower dose level will be expanded to 6 patients in total. The highest dose among the dose levels tested at which no more than one out of six patients experiences DLT will be considered the MTD. Dose exploration can be discontinued once one or more dose levels with an acceptable safety profile and satisfactory antitumor activity have been selected for subsequent evaluation.

During the treatment period of the study, three dose levels of CGC729 will be evaluated. Each of the dose levels will evaluate the safety of the CAR-NKT cells.

Connect with a study center

  • Jian Zhang

    Shanghai,
    China

    Active - Recruiting

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