Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD1… (NCT07539610) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors
China9 participantsStarted 2026-04
Plain-language 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
Who can participate
Age range18 Years – 69 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 malignancie…
What they're measuring
1
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)
Timeframe: up to 28 after CAR-T cell infusion
Trial details
NCT IDNCT07539610
SponsorInstitute of Hematology & Blood Diseases Hospital, China