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

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Dec 10, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment option using a type of immune cells called CD70-targeted CAR-NKT cells for patients with advanced malignant solid tumors, which are cancers that have spread and are difficult to treat. The study aims to find out if this therapy is effective and safe for patients, and it's currently looking for participants aged 18 to 75 who have had their cancer come back after at least two previous treatments. To be eligible, patients must have a specific type of cancer that tests positive for a marker called CD70 and must have at least one measurable tumor.

Participants in this trial can expect to receive this experimental treatment and will be closely monitored for its effects. The trial is open to all genders, and it is important that potential participants are in generally good health with normal organ function and understand what the study involves. However, certain conditions may exclude individuals from participating, such as recent use of other cancer therapies or specific health issues. If you or a loved one are considering participation, it’s essential to discuss this with your healthcare provider to determine if it’s a suitable option.

Gender

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Eligibility criteria

• 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.