A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors

Trial Title: A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors

NCT ID: NCT06394622

Condition: Solid Tumor

Conditions: Official terms:
Neoplasms
Cyclophosphamide
Fludarabine

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells
Description: Biological: CD70 CAR-NKT cells. Drug: Cyclophosphamide. Drug: Fludarabine.
Arm group label: Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells

Summary: This is a phase I, open-label, single-arm study conducted to evaluate the efficacy, safety and PK of CGC729 in the treatment of advanced malignant solid tumors. Condition or disease:advanced malignant solid tumors. Intervention/treatment:Biological: CD70 CAR-NKT cells. Phase:I

Detailed description: This was a dose-expansion study, we plan to enroll 6 to 12 patients with CD70-positive advanced malignant solid tumors to CGC729 treatment. The intended enrollment for the evaluation of treatment efficacy and safety was planned to be 3 to 6 patients per tumor type. We used leukapheresis for cell collection. The lymphodepletion procedure was conducted using a combination of fludarabine and cyclophosphamide.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age 18 to 75 years. - ECOG 0-1 points. - The expected survival time is more than 3 months. - Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment. - IHC: CD70 positive. - At least one measurable lesion at baseline per RECIST version 1.1. - 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.Prothrombin time (PT) : INR < 1.7. - Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception. - 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. Exclusion Criteria: - Use of cell therapy within the previous one month. - Risk of severe bleeding in esophageal cancer - 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. - Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms in the past 6 months. - Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion. - Active hepatitis B, HIV positive and HCV positive - Active infection or uncontrollable infection. - 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. - Unstable respiratory diseases, including interstitial pneumonia. - Uncontrolled ascites and pleural effusion - Known to have active or uncontrolled autoimmune diseases, such as Crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. . - Subjects who are using systemic steroids or steroid inhalers for treatment. - Pregnant or lactating female subjects. - Other investigators deem it unsuitable to participate in the study.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Jian Zhang

Phone: 18017312991
Email: Syner2000@163.com

Start date: April 11, 2024

Completion date: June 28, 2026

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06394622