Status:
UNKNOWN
CD70-targeted CAR-NKT Cells(CGC729) Therapy in the Renal Cell Carcinoma
Lead Sponsor:
Fudan University
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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. Condi...
Detailed 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...
Eligibility Criteria
Inclusion
- Subjects or their guardians agree to participate in this clinical trial and sign the ICF, indicating that they understand the purpose and procedures of this clinical trial and are willing to participate in the research.
- Age 18 to 75 years.
- Patients with advanced clear cell renal cell carcinoma confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment.
- Archival and/or fresh tumor tissue samples are required.
- At least one measurable lesion at baseline per RECIST version 1.1.
- ECOG 0-1 points.
- The expected survival time is more than 12 weeks.
- 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 for patients with liver metastases); Total bilirubin≤1.5×ULN. Coagulation INR \< 1.7.
- Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception.
Exclusion
- Pregnant or lactating female subjects.
- Pregnant or lactating female subjects.
- Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS).
- Active infection or uncontrollable infection.
- Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. .
- 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 relevant questionnaire.
- Have a serious uncontrollable illness that may affect the subject receiving treatment for this study.
- 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.
- Subjects who are using systemic steroids or steroid inhalers for treatment.
- Use of anti-CD70 therapy or cell therapy within the previous 3 months.
- Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion.
- Subjects allergic to immunotherapy or related drugs.
- Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months.
- Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standard therapy requiring special treatment, previous history of myocarditis, or myocardial infarction within 6 months.
- Earnestly received or organ transplantation or preparing to receive organ transplants.
- Other investigators deem it unsuitable to participate in the study.
Key Trial Info
Start Date :
July 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 28 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06182735
Start Date
July 17 2023
End Date
January 28 2025
Last Update
December 27 2023
Active Locations (1)
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1
Jian Zhang
Shanghai, China