B-Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia/Lymphoma
Conditions
Brief summary
Evaluation of Sup19 CAR-T cells in cases where previous CD19-targeted therapy has failed or where CD19 Evaluation of Safety and Efficacy in the Treatment of Low-Grade Hematological Malignancies: A Prospective, Single-Arm Clinical Study Research
Interventions
BIOLOGICALSup19 CAR-T
The use of Sup19 CAR-T cells to treat hematologic malignancies with prior CD19-targeted therapy failure or CD19 weak expression aims to improve the relapse-free survival rate in patients with hematologic malignancies, providing a novel curative strategy for these patients.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sup19 CAR-T
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥18 and \<70 years, of any gender; * diagnosed with B-ALL/LBL according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1); * meeting either of the following two criteria: (1) Previous targeted CD19 therapy, including bispecific antibodies, ADC drugs, and CAR-T, with continued CD19 expression; (2) Patients with hematological malignancies who have not received CD19-targeted therapy in the past, with weakly positive CD19 expression; * At the time of screening, the number of blasts in the bone marrow is 25% (bone marrow morphology) and/or extramedullary lesions; * Meeting the diagnosis of relapsed/refractory B-ALL/LBL, including any of the following situations: a. Primary refractory patients who have not achieved complete remission after two cycles of standardized chemotherapy or patients who have not achieved complete remission after multiple salvage chemotherapy regimens; b. Patients who relapse within 12 months after achieving complete remission or relapse after 12 months of achieving complete remission and have not achieved complete remission after one or more courses of standard treatment induction; c. Patients who relapse after hematopoietic stem cell transplantation or after CAR-T therapy targeting the same target; * Other relapsed/refractory CD19 weakly expressing hematological malignancies; * Creatinine clearance rate \> 60 ml/min (Cockcroft and Gault formula); for patients without liver involvement, total serum bilirubin \< 3 times the upper limit of normal, and both serum ALT and AST \< 5 times the upper limit of the normal range. * Echocardiography shows left ventricular ejection fraction (LVEF) of 250%; * Finger pulse oxygen saturation \> 92%;--Estimated survival period of more than 3 months; * Estimated survival period of more than 3 months; * ECOG score of 0-2; * The subject or his/her legal guardian voluntarily participates in this trial and signs the informed consent form.
Exclusion criteria
* Acute promyelocytic leukemia (APL); * presence of hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known myelodysplastic syndrome; * uncontrolled active central nervous system leukemia (CNSL), i.e., cerebrospinal fluid (CSF) classification CNS 3; * prior administration of antineoplastic therapy before infusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation of Sup19 CAR-T cell therapy in patients with hematologic malignancies who have failed prior CD19-targeted therapy or exhibit weak CD19 expression: dose-limiting toxicity (DLT) adverse events (with particular focus on CRS and ICANS) | up to 28 after CAR-T cell infusion |
Secondary
| Measure | Time frame |
|---|---|
| The best response rate of Sup19 CAR-T cell therapy within 3 months(The proportion of patients achieving CR/CRi) | Sup19 CAR-T cell therapy within 3 months |
| Duration of response (DOR) | After the Sup19 CAR-T infusion, the time from the first achievement of CR/CRi + PR to disease recurrence or death due to leukemia (follow-up monitoring until 3 years after infusion). |
| Event-free Survival, (EFS） | The time from the administration of Sup19 CAR-T to the earliest occurrence of the event (follow-up monitoring until 3 years after infusion) |
| Leukemia-free Survival, (LFS） | The time from the first occurrence of CR/CRi (ALL/LBL) to recurrence or death. (follow-up monitoring until 3 years after infusion) |
| The proportion of patients who received hematopoietic stem cell transplantation under the alleviated condition | The proportion of subjects who achieved remission after infusion and who received HSCT. (Follow-up monitoring was conducted until 3 years after the infusion) |
| Overall Survival,(OS） | The time from the first infusion of CAR-T cells to death due to any cause (Follow-up monitoring was conducted until 3 years after the infusion) |
| Negative rate of Minimal Residual Disease（MRD） | 28 days after the Sup19 CAR-T infusion |
Countries
China
Contacts
CONTACTwangying PI
Outcome results
None listed