Acute Lymphoblastic Leukemia (ALL) Clinical Trial
Official title:
A Safety and Efficacy Study of CD19-UCART (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor) in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Verified date | March 2023 |
Source | Bioray Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Suspended |
Enrollment | 20 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 65 Years |
Eligibility | Inclusion Criteria: 1. Voluntarily participating in this clinical study and signing the informed consent form; The estimated survival period is at least one month; 2. No other serious cardiopulmonary diseases, and normal liver and kidney functions (except for subjects with tumor lesions in their liver and kidneys); 3. 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; 4. 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); 5. 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; 6. 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; 7. Cardiac function: Good hemodynamic stability, and the left ventricular ejection fraction (LVEF) = 55%; 8. Serum viral EBV-DNA, CMV-DNA, HIV antibody and syphilis antibody, HBV, HCV virus quantification were all negative; 9. ECOG activity status score: 0-2 points; 10. 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; 11. Willing to comply with the rules established in this protocol; 12. 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 Criteria: 1. Pregnant or lactating women; 2. 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; 3. Single extramedullary relapse B-ALL; 4. Suffering from severe mental disorder; 5. Active autoimmune diseases requiring immunotherapy; 6. History of other malignant tumors; 7. Patients with severe cardiovascular disease; 8. Organ function is in the following abnormalities; 9. Total bilirubin > 1.5 times the upper limit of normal unless the patient is Gilbert's syndrome; 10. Partial thromboplastin time or activated partial thromboplastin time or international normalized ratio >1.5*ULN;in the absence of anticoagulant therapy; 11. There is an active infectious disease or any major infectious event requiring high-level antibiotics; 12. Any condition that, in the opinion of the investigator, may increase the subject's risk or interfere with the test results. |
Country | Name | City | State |
---|---|---|---|
China | First Affliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
China | First Affliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Bioray Laboratories | First Affiliated Hospital of Zhejiang University, Second Xiangya Hospital of Central South University, The First Affiliated Hospital of Zhengzhou University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | UCART cell survival time | The number of UCART cells surviving in the body within 90 days after receiving the study drug; | up to 1 year after infusion | |
Other | Progrssion-free survival | The time from treatment with study drug to tumor progression or death. | up to 2 years after infusion | |
Other | Overall survival | the time from treatment with study drug to death by any cause. | up to 2 years after infusion | |
Primary | Dose Limiting Toxicities (DLTs) occurence | Adverse events assessed according to NCI-CTCAE v5.0 criteria | Baseline up to 35 days after T cell infusion | |
Secondary | Objective Response Rate | The total response rate after 90 days of treatment with study drug (overall response rate for ALL= CR+CRi; for NHL=CR+PR); | At 12 weeks, and overall | |
Secondary | Day 90 progression-free survival | The 90-day progression-free survival rate following drug therapy. | Assessed up to 3 months |
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