Status:
SUSPENDED
Safety and Efficacy Evaluation of CD19-UCART
Lead Sponsor:
Bioray Laboratories
Collaborating Sponsors:
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Zhejiang University
Conditions:
Acute Lymphoblastic Leukemia (ALL)
Non Hodgkin Lymphoma (NHL)
Eligibility:
All Genders
1-65 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ascending doses of CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies.
Detailed Description
CD19-UCART is a kind of "off-the-shelf" product originated from health donor's PBMC.This is a open-label, dose estilation study to evaluate the safety and anti-tumor efficacy of CD19-UCART in the trea...
Eligibility Criteria
Inclusion
- Voluntarily participating in this clinical study and signing the informed consent form; The estimated survival period is at least one month;
- No other serious cardiopulmonary diseases, and normal liver and kidney functions (except for subjects with tumor lesions in their liver and kidneys);
- Failure of T cell isolation during autologous CART preparation or failure of CART amplification or failure to complete apheresis or disease progression resulting in patients not benefiting from autologous CAR-T cell therapy; Or: T cell percentage in PBMC of peripheral blood ≤ 10%; Or the disease is not effectively controlled within one month after autologous CAR-T transfusion, and the patient cannot receive CAR-T transfusion again;
- Flow cytometry within two months demonstrated positive expression of CD19 in the tumor (positive rate 50%-90%; Or biopsy ≥ 50% within 6 months; Or obtaining a biopsy again);
- Hematological indicators: 1) WBC count ≥ 1.5× 10\^9/L; Absolute value of neutrophils ≥ 0.8× 10\^9/L; Lymphocyte count ≥0.1×10\^9/L;2) Hemoglobin ≥ 60g/L;3) Platelet count ≥20×10\^9/L;
- Biochemical indicators (except for subjects with tumor foci in liver and kidney): Total bilirubin (TBIL)≤1.5 times the Upper Limits of Normal (ULN); AST and ALT≤1.5 \*ULN; Scr and BUN)≤1.5\*ULN; Biochemical indicators in subjects with liver and kidney invasion should meet: Total bilirubin (TBIL)≤5 \*ULN;AST and ALT≤5\*ULN; Scr and BUN ≤ 5\*ULN;
- Cardiac function: Good hemodynamic stability, and the left ventricular ejection fraction (LVEF) ≥ 55%;
- Serum viral EBV-DNA, CMV-DNA, HIV antibody and syphilis antibody, HBV, HCV virus quantification were all negative;
- ECOG activity status score: 0-2 points;
- Female subjects must have access to effective contraceptive measures (e.g., oral prescription contraceptives, injectable contraceptives, intrauterine devices, double blocking, contraceptive patches, male partner sterilizations) throughout the study period; Serum or urine pregnancy test results must be negative at screening and throughout the study;
- Willing to comply with the rules established in this protocol;
- Patients with relapsed/refractory CD19-positive acute B-cell leukemia (B-ALL, with the age of 1-60 years) or relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL, with the age of 5-65 years).
Exclusion
- Pregnant or lactating women;
- The following drugs or treatments should be excluded:High-dose glucocorticoids were used within 72h prior to UCAR-T infusion, except for physiological alternative therapies;Allogeneic cell therapies such as donor lymphocyte transfusion within 6 weeks prior to UCAR-T transfusion;GVHD treatment;
- Single extramedullary relapse B-ALL;
- Suffering from severe mental disorder;
- Active autoimmune diseases requiring immunotherapy;
- History of other malignant tumors;
- Patients with severe cardiovascular disease;
- Organ function is in the following abnormalities;
- Total bilirubin \> 1.5 times the upper limit of normal unless the patient is Gilbert's syndrome;
- Partial thromboplastin time or activated partial thromboplastin time or international normalized ratio \>1.5\*ULN；in the absence of anticoagulant therapy;
- There is an active infectious disease or any major infectious event requiring high-level antibiotics;
- Any condition that, in the opinion of the investigator, may increase the subject's risk or interfere with the test results.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03229876
Start Date
June 1 2019
End Date
December 30 2023
Last Update
July 24 2023
Active Locations (2)
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1
First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
2
First Affliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310003