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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- Age 18 to 75 years.
- Patients with advanced clear cell renal cell carcinoma confirmed by histology orcytology 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 forpatients 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 womenagreed to use effective contraception.
Exclusion
Exclusion Criteria:
- Pregnant or lactating female subjects.
- Pregnant or lactating female subjects.
- Known positive test result for human immunodeficiency virus (HIV) oracquired immunedeficiency 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 relevantquestionnaire.
- Have a serious uncontrollable illness that may affect the subject receiving treatmentfor this study.
- 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.
- 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 2weeks before cell infusion.
- Subjects allergic to immunotherapy or related drugs.
- Patients with leptomeningeal metastasis or central nervous system metastasis, anddefinite central nervous system underlying diseases with significant symptoms in thepast 6 months.
- Subjects with NYHA heart failure class ≥2 or hypertension uncontrolled by standardtherapy requiring special treatment, previous history of myocarditis, or myocardialinfarction within 6 months.
- Earnestly received or organ transplantation or preparing to receive organ transplants.
- 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
Connect with a study center
Jian Zhang
Shanghai,
ChinaActive - Recruiting
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