Allogeneic B7H3 CAR-γδT Cell Therapy for Advanced Solid Tumors

Launched by PEKING UNIVERSITY · Feb 9, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment using a type of immune cell called γδT cells for patients with advanced solid tumors, including ovarian and peritoneal cancers. The researchers are particularly interested in a specific target called B7H3, which is found in high amounts in many tumors but not in normal tissues. This treatment aims to provide a safer option with fewer side effects compared to traditional therapies, by using these special γδT cells that can recognize and attack cancer cells more effectively.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of a malignant solid tumor that hasn't responded to standard treatments. They should also have a good overall health status, meaning they can carry out daily activities with minimal limitations. Participants will receive detailed information about the trial and will need to sign a consent form, agreeing to take part. Since this is an early-stage trial, those who join will be among the first to test this innovative therapy, and they will be closely monitored by medical professionals throughout the process.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years old, gender is not limited;
• • 2. Expected survival time ≥3 months;
• • 3. ECOG score 0\~1;
• • 4. Patients who meet the clinical diagnostic criteria and have a clear pathological diagnosis of malignant solid tumors that have failed standard treatment;
• • 5. Tumor tissue samples (specimens within one year are recommended) positive for B7H3 by immunohistochemical (IHC) staining or flow assay;
• • 6. Presence of at least one evaluable lesion according to RECIST V1.1;
• • 7. Tumors limited to peritoneal (metastatic) and ovarian cancer in patients in the laparotomy group;
• 8. Substantially normal bone marrow reserve function and normal liver and renal function (laboratory tests need to be fulfilled before the first treatment with cell injection):
• • Blood: white blood cell count (WBC) ≥3E9/L, lymphocyte count (LY) ≥0.8E9/L, hemoglobin (Hb) ≥80g/L, platelet (PLT) ≥75E9/L; Liver: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; total bilirubin ≤ 3.0 × ULN; Kidney: serum creatinine ≤ 1.5 × upper limit of normal range (ULN); Heart: left ventricular ejection fraction ≥50% on echocardiography; lung: normal oxygen saturation without oxygen.
• • 9. Pregnancy test should be negative for women of childbearing potential and both men and women agree to use effective contraception during treatment and for 1 year thereafter;
• • 10. Be able to understand the requirements and matters of the trial and be willing to participate in the clinical study as required;
• • 11. Sign the trial informed consent form.
• Exclusion Criteria:
• • 1. Known hypersensitivity, allergy, intolerance, or contraindication to cell infusion or any of the drug components that may be used in the study, including fludarabine and cyclophosphamide;
• • 2. Patients who have been continuously using immunosuppressive drugs within 1 month prior to cell infusion;
• • 3. Cerebrovascular accident or seizure within 6 months prior to signing the informed consent form;
• • 4. Symptomatic brain metastases;
• • 5. a known psychiatric or substance abuse disorder that would interfere with cooperation with the trial requirements;
• • 6. Hepatitis B surface antigen (HBsAg) positivity or hepatitis B core antibody (HBcAb) positivity and a peripheral blood test for hepatitis B virus (HBV) DNA titer that is not within the normal reference range; hepatitis C virus (HCV) antibody positivity and peripheral blood hepatitis C virus (HCV) RNA positivity; human immunodeficiency virus (HIV) antibody positivity; syphilis Positive for syphilis;
• • 7. Serious cardiac disease: including, but not limited to, unstable angina pectoris, myocardial infarction (occurring within 6 months prior to screening), congestive heart failure (NYHA classification ≥ III), and severe arrhythmias;
• • 8. Presence of active or uncontrolled infections requiring systemic therapy (except for mild genitourinary and upper respiratory tract infections);
• • 9. has not recovered from acute toxic effects of prior therapy (prior therapy-induced hematologic or organ toxicity ≥ Grade 2, except for abnormalities related to study disease and medical history);
• • 10. have a confirmed diagnosis of an immunodeficiency
• • 11. suffering from an active infection requiring systemic therapy;
• • 12. a female subject of childbearing potential who plans to become pregnant within 2 years of cell infusion; or a male subject whose partner plans to become pregnant within 2 years of cell infusion;
• • 13. Participation in a clinical study of another innovative drug within 1 month prior to screening;