Status:
UNKNOWN
Universal Chimeric Antigen Receptor-modified AT19 Cells for CD19+ Relapsed/Refractory Hematological Malignancies
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Chengdu USino Technology Biology Co., Ltd
Conditions:
Acute Lymphoblastic Leukemia
Chronic Lymphoblastic Leukemia
Eligibility:
All Genders
14-78 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of universal chimeric antigen receptor-modified AT19 cells in patients with relapsed or refractory hem...
Detailed Description
* Adoptive transfer of autologous anti-CD19 CAR-T cells can induce durable remissions in patients with relapsed/refractory hematologic malignancies, including CD19+ B-cell acute lymphoblastic leukemia...
Eligibility Criteria
Inclusion
- Aged 14-78 years old (including 14 and 78 years old).
- Clinical diagnosis of CD19+ B-cell hematological malignancies, including acute lymphoblastic leukemia, chronic lymphocytic leukemia and lymphoma.
- Refractory/Relapsed B-cell malignancies:
- A. Refractory/relapsed B-cell lymphoblastic leukemia, meeting one of the following criteria:
- i. Recurrence within 6 months after first remission. ii. Primary refractory disease which cannot achieve complete remission (CR) after 2 cycles of standardized chemotherapy regimen.
- iii. Failure to achieve CR or relapse after one line or multiple lines of salvage chemotherapy.
- iv. Not suitable for hematopoietic stem cell transplantation (HSCT), or abandon HSCT due to various restrictions, or relapse after HSCT.
- B. Refractory/relapsed B-cell lymphoma, meeting 1 of the first 4 items plus item 5: i. Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
- ii. Achieved CR after standard chemotherapy, but relapsed within 6 months. iii. 2 or more relapses after CR. iv. Not suitable for HSCT, or abandon HSCT due to various restrictions, or relapse after HSCT.
- v. Subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines.
- Having a measurable or evaluable lesion:
- A. Patients with lymphoma require a single lesion≥15mm or 2 or more lesions≥10mm.
- B. Patients with leukemia require persistent positive or positive relapse of bone marrow MRD.
- The toxicity related to previous treatments had returned to \< 1 level at enrollment (except for low grade toxicity such as alopecia).
- Patients have good main organs functions:
- A. Liver function: ALT/AST \< 2.5 times the upper limit of normal (ULN) and total bilirubin≤ 1.5 times ULN; B. Renal function: Creatinine clearance rate ≥ 60ml/min. C. Pulmonary function: Indoor oxygen saturation ≥ 95%. D. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥50%, no clinically-significant ECG findings.
- Estimated survival time≥3 months.
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
Exclusion
- Central nervous system is involved in leukemia and lymphoma.
- Known HIV positive patients.
- CNS diseases, such as epilepsy, cerebral ischemia / hemorrhage, dementia, cerebellar diseases or any CNS related autoimmune diseases.
- NYHA class III or higher cardiac failure, or with malignant arrhythmia.
- Myocardial infarction, angioplasty or stent placement, unstable angina or other clinically significant heart history within 12 months before enrollment.
- Patients who need immediate treatment to control tumor progression or relieve tumor burden.
- Active autoimmune diseases requiring systemic immunosuppressive therapy.
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment.
- Severe immediate hypersensitivity to any drug to be used in this study.
- Women who are pregnant or breastfeeding.
- Other unsuitable conditions in the researchers' opinion.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04796688
Start Date
March 10 2021
End Date
March 10 2024
Last Update
March 15 2021
Active Locations (2)
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1
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
2
Union Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022