Autologous Cells Derived Anti-CD7 CAR-Engineered T Cells for T Lymphoid Malignancies

• Status: Recruiting
• Trial end date: 2024-04-07
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of autologous anti-CD7 chimeric antigen receptor(CAR)-modified T cells(CAR7-Ts) in patients with relapsed or refractory T lymphoid malignancies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Collaborators: Beijing Gaobo Biotechnology Co., Ltd; Beijing GoBroad Hospital Management Co.,Ltd; Shanghai YaKe Biotechnology Ltd.
• Treatments: Cyclophosphamide; Fludarabine

Criteria

Inclusion Criteria:

1. Aged ≥ 18 years;

2. Expected survival over 60 days;

3. Eastern Cooperative Oncology Group score 0-2;

4. Diagnosed as T-cell hematologic malignancies (including leukemia and lymphoma) according to WHO2016 criteria;

5. Patients must relapse or be refractory after at least two lines of therapy.

6. CD7 were positive in bone marrow by immunohistochemistry or flow cytometry at screening, and one of the following conditions is satisfied: A. No remission was achieved after at least 2 lines of standard therapy; B. Relapse or progression after standard treatment; C. Relapse after autologous or allogeneic hematopoietic stem cell transplantation;

7. Have no fertility requirements or plans for one year since enrolment in this clinical trial;

8. Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.

Exclusion Criteria:

1. Complicated with central system leukemia/lymphoma;

2. Existing or preexisting CNS conditions, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS related autoimmune disease;

3. Symptomatic heart failure or severe arrhythmias;

4. Symptoms of severe respiratory failure;

5. Complicated with other types of malignant tumors;

6. Serum creatinine and/or urea nitrogen ≥ 1.5 times of normal value;

7. Suffer from sepsis or other uncontrollable infections;

8. Intracranial hypertension or brain consciousness disorder;

9. Severe mental disorders;

10. Have received organ transplantation (excluding bone marrow transplantation);

11. Female patients (fertile patients) had positive blood HCG test;

12. Hepatitis (including hepatitis B and C), AIDS and syphilis were screened positive;

13. Patients with graft-versus-host disease (GVHD) or who require immunosuppressant treatment;

14. The absolute value of lymphocytes was too low to manufacture CART cells;

15. Other conditions considered inappropriate by the researcher.