Autologous and Donor-derived CD7 CAR-T Therapy in Refractory or Relapsed T-cell Malignancies

Launched by BEIJING GOBROAD HOSPITAL · Mar 14, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with a type of leukemia called T-cell acute lymphoblastic leukemia (T-ALL) or lymphoma that has not responded to standard therapies. The treatment involves using specially modified immune cells, known as CD7 CAR-T cells, that are derived from the patient's own blood or from a donor. The main goals of the trial are to check how safe this treatment is and to see how effective it can be in helping patients with their cancer. The study will enroll around 80 participants, and the researchers will closely monitor participants for any side effects and cancer responses over a few months.

To be eligible for this trial, patients must be between 1 and 70 years old and have cancer that expresses a specific marker called CD7. They should have already tried standard treatments without success and have a life expectancy of at least 60 days. However, certain health issues, such as severe infections or heart problems, would exclude someone from joining the study. Participants can expect regular check-ups and tests to track their health and treatment response throughout the trial, and they will need to provide informed consent, meaning they understand and agree to be part of the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Only patients who meet all the following criteria can be included in the group:
• • 1. CD7-positive refractory or relapsed T-cell malignancies with progression or intolerance after all standard treatments, limited prognosis from currently available treatments and no available treatment options (e.g. HSCT or chemotherapy).
• • 2. Tumor cells in bone marrow or cerebrospinal fluid are positive for CD7 antigen by flow cytometry or tumour tissue is positive for CD7 by immunohistochemistry (CD7 antigen positivity by flow cytometry: \>80% of tumour cells expressing CD7 with a mean fluorescence intensity \[MFI\] of CD7 similar to that of normal T cells are considered to have fully positive expression; \>80% of tumor cells expressing CD7 but with an MFI of CD7 at least 1 log lower than that of normal T cells are considered to have low expression \[dim\]; tumor cells with a CD7 expression rate between 20-80% are considered to have partial expression; CD7 antigen positivity by pathological immunohistochemistry: \>30%);
• • 3. Male or female, age 1-70 years;
• • 4. No severe allergic constitution;
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al., 1982) of 0-2;
• • 6. Life expectancy of at least 60 days as determined by the investigator;
• • 7. Provide a signed informed consent form prior to any screening procedures; subjects volunteering to participate in the study should be capable of understanding and signing the informed consent form and be willing to follow the study visit schedule and associated study procedures as specified in the protocol. Subjects aged 19-70 years old need to be sufficiently aware and capable of signing the informed consent form; subjects aged 1-7 years can be recruited after legal guardians or patient advocates sign the informed consent form; subjects aged 8-18 years need to be sufficiently aware and able to sign the informed consent form, and their legal guardians or patient advocates also need to sign the informed consent form.
• Exclusion Criteria:
• Patients with at least one of the following conditions are excluded:
• • 1. Intracranial hypertension or unconscious;
• • 2. Acute heart failure or severe arrhythmia;
• • 3. Acute respiratory failure;
• • 4. Other types of malignant tumors;
• • 5. Diffuse intravascular coagulation;
• • 6. Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value;
• • 7. Sepsis or other uncontrolled infection;
• • 8. Uncontrolled diabetes mellitus;
• • 9. Severe psychological disorder;
• • 10. Obvious cranial lesions by cranial MRI;
• • 11. Allergic constitution;
• • 12. Organ recipients;
• • 13. Pregnant or breastfeeding;
• • 14. Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).