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RECRUITING

NCT06728189

PHASE1

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

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

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 malignant solid tumors. Condition or disease：advanced malignant solid tumors Intervention/treatment：Biological: CD70 CAR-NKT cells Phase：Phase 1

Official title: A Clinical Research Evaluating the Safety and Efficacy of CD70-targeted CAR-NKT Cells (CGC738) Therapy in Subjects with Advanced Malignant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-11-14

Completion Date

2026-10-17

Last Updated

2024-12-11

Healthy Volunteers

Conditions

Advanced Malignant Solid Tumors

Interventions

BIOLOGICAL

CAR-NKT Cells treatment

Cyclophosphamide + Fludarabine + Infusion of CAR-NKT Cells Lymphodepleting regimen, Cyclophosphamide 250mg/m2 IV on day -5 to -3 and Fludarabine 25mg/m2 IV on days -5 to -3. Followed by infusion of CAR-NKT on day 0. Potential CGC738 doses: Dose level 1: 5.0×106 CAR- NKT cells/m2; Dose level 2: 1.5×107 CAR- NKT cells/m2; Dose level 3: 4.5×107 CAR- NKT cells/m2;

Inclusion Criteria: 1. Age 18 to 75 years. 2. ECOG 0-1 points. 3. The expected survival time is more than 3 months. 4. Patients with advanced advanced malignant solid tumor confirmed by histology or cytology to be recurrent or metastatic after at least second-line treatment. 5. IHC: CD70 positive. 6. At least one measurable lesion at baseline per RECIST version 1.1. 7. The functions of important organs are basically normal: 8. Pregnancy tests for women of childbearing age shall be negative, Both men and women agreed to use effective contraception. 9. 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: 1. Use of cell therapy within the previous one month. 2. 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. 3. Patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms. 4. Immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion. 5. Active hepatitis B, HIV positive and HCV positive. 6. Active infection or uncontrollable infection. 7. 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. 8. Unstable respiratory diseases, including interstitial pneumonia. 9. 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.

Locations (1)

Beijing Cancer Hospital

Beijing, China