Status:
UNKNOWN
Anti-CD7 CAR-Engineered T Cells for T Lymphoid Malignancies Malignancies
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Beijing GoBroad Hospital Management Co.,Ltd
Yake Biotechnology Ltd.
Conditions:
T-Cell Lymphocytic Leukemia
T-Cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
14-70 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of anti-CD7 chimeric antigen receptor(CAR)-modified T cells(CAR7-Ts) in patients with relapsed or refr...
Detailed Description
Chimeric antigen receptor-T cells (CAR-T) have made breakthroughs in the treatment of B-cell tumors, especially refractory/relapsed acute B lymphocytes. CD7 is a transmembrane glycoprotein expressed b...
Eligibility Criteria
Inclusion
- Aged from 14 to 70 years;
- Expected survival over 60 days;
- Eastern Cooperative Oncology Group score 0-2;
- Diagnosed as T-cell hematologic malignancies (including leukemia and lymphoma) according to WHO2016 criteria;
- Patients must relapse or be refractory after at least two lines of therapy.
- CD7 were positive in bone marrow or cerebrospinal fluid 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;
- Have no fertility requirements or plans for one year since enrollment in this clinical trial;
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
Exclusion
- Complicated with central system leukemia/lymphoma with active intracranial lesions;
- Existing or preexisting CNS conditions, such as epileptic seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any CNS related autoimmune disease;
- Symptomatic heart failure or severe arrhythmias;
- Symptoms of severe respiratory failure;
- Complicated with other types of malignant tumors;
- Serum creatinine and/or urea nitrogen ≥ 1.5 times of normal value;
- Suffer from sepsis or other uncontrollable infections;
- Intracranial hypertension or brain consciousness disorder;
- Severe mental disorders;
- Have received organ transplantation (excluding bone marrow transplantation);
- Female patients (fertile patients) had positive blood HCG test;
- Hepatitis (including hepatitis B and C), AIDS and syphilis were screened positive;
- Patients with graft-versus-host disease (GVHD) or who require immunosuppressant treatment;
- The absolute value of lymphocytes was too low to manufacture CART cells;
- Other conditions considered inappropriate by the researcher.
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 7 2024
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04823091
Start Date
April 15 2021
End Date
April 7 2024
Last Update
March 16 2022
Active Locations (1)
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1
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022