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

Recruiting now · Phase 1

Conditions studied: Advanced Malignant Solid Tumors

In brief

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

Key facts

Study ID

NCT06728189

Run by

Peking University Cancer Hospital & Institute

People needed

13

Starts

2024-11-14

Expected to finish

2026-10-17

Last updated by the study team

2024-12-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• Use of cell therapy within the previous one month.
• 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.
• 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.

Where it is running

• Beijing Cancer Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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