Relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia
Conditions
Interventions
Dose1-5:Enrolled patients receive STR-P004 at the corresponding dose via intravenous infusion, administered four times (D1, D4, D7, D10). A complete cycle consists of four infusions. Each dose allows
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia who currently have poor prognosis treatment options: 1. Patients voluntarily sign the informed consent form; 2. Age between 18 and 65 years, regardless of gender; 3. Diagnosed with B-cell acute lymphoblastic leukemia and meeting any of the following conditions: (1) Relapse: Relapse within 12 months after first remission following standard treatment; (2) Refractory: a) No remission after >=6 weeks of induction therapy or two courses of induction therapy; b) Relapse after >=2 complete remissions (CR) or CR with incomplete hematologic recovery (CRi); c) First relapse after chemotherapy, with no remission after at least one salvage therapy; d) Relapse after autologous or allogeneic hematopoietic stem cell transplantation; 4. Within 3 months before screening, bone marrow or peripheral blood tests show leukemia cells expressing CD19; 5. For Ph+ ALL patients, treatment failure with at least two tyrosine kinase inhibitors (TKIs) (including at least one second-generation TKI) or intolerance to TKI therapy; if the patient has a T315I mutation, TKI salvage therapy is not required; 6. During screening, the proportion of bone marrow blasts and immature lymphocytes is =5%; 7. Hemoglobin >=60 g/L, platelets >=30 × 10^9/L; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 9. Adequate organ function, meeting the following criteria: Aspartate aminotransferase (AST) =60 mL/min (Cockcroft and Gault formula); Minimum lung reserve: defined as 91% without oxygen supplementation; International normalized ratio (INR) =12 consecutive months of amenorrhea).
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria cannot be enrolled: 1. Active central nervous system (CNS) leukemia (patients with CNS disease symptoms must undergo lumbar puncture to exclude CNS leukemia); 2. Isolated extramedullary relapse; 3. Prior CAR-T therapy or other genetically modified cell therapy within 6 months before screening; 4. Chemotherapy within 2 weeks before dosing, except for the following: Pre-treatment chemotherapy as specified in the protocol; TKI and hydroxyurea must be discontinued 72 hours before cell infusion; 6-mercaptopurine, 6-thioguanine, methotrexate (standard dose), cytarabine (standard dose), vincristine, and asparaginase must be discontinued 1 week before cell infusion; Intrathecal chemotherapy for CNS leukemia prophylaxis must be discontinued 1 week before cell infusion; 5. Systemic corticosteroid therapy discontinued for less than 72 hours before dosing, except for physiological replacement doses (e.g., prednisone =480 ms (QTcB = QT/RR^(1/2)); Uncontrolled hypertension (systolic pressure >=140 mmHg and/or diastolic pressure >=90 mmHg) or pulmonary hypertension despite standard treatment; Unstable angina; Myocardial infarction or coronary artery bypass graft/stent surgery within 6 months before dosing; Clinically significant valvular disease; Other cardiac diseases deemed unsuitable for enrollment by the investigator; 11. Clinically significant pleural effusion at screening; 12. History of epilepsy, cerebral ischemia/hemorrhage, cerebellar disease, or other active CNS diseases; 13. History of deep vein thrombosis or pulmonary embolism within 6 months before screening; 14. Known history of hypersensitivity to any component of the study drug; 15. Live vaccination within 6 weeks before screening; 16. Active infection at screening; 17. Expected lifespan less than 3 months; 18. Participation in another interventional clinical study within 3 months before screening involving investigational drugs not yet marketed, or within 5 half-lives for marketed drugs; or intention to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the study; 19. Other conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose limiting toxicity, DLT;AE/SAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Tmax;Objective relief rate;Duration of relief;disease control rate;Recurrence free survival; | — |
Countries
China
Contacts
Public ContactSuning Chen
The First Affiliated Hospital of Soochow University
Outcome results
None listed