Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL (NCT06641024) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL
China24 participantsStarted 2024-11-01
Plain-language summary
This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B Cell Acute Lymphoblastic Leukemia.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
✓. Age ≥ 18 years old (including threshold), gender not limited;
✓. Diagnosed with B-cell acute lymphoblastic leukemia and meeting one of the following conditions:
✓. Refractory B-ALL: Early refractory patients who have not achieved complete remission of bone marrow after two courses of first-line systemic therapy upon initial diagnosis;
✓. Relapsed B-ALL:
✓. Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they have relapsed/refractory disease despite treatment with at least 2 different tyrosine kinase inhibitors (TKIs); (Note: Except for those who are intolerant to TKI therapy, or have T315i mutations);
✓. Flow cytometry confirms the expression of CD19 in leukemia cells in the bone marrow. In individuals previously treated with targeted CD19 antibodies (such as blinatumomab), the proportion of CD19 positive cells in leukemia cells must be ≥ 90%;
✓. Morphological disease in the bone marrow (≥ 5% blasts);
Exclusion criteria
✕. Isolated extramedullary disease;
✕. Central nervous system abnormalities: defined as CNS-2 and 3 according to NCCN guidelines (note: CNS-2 and 3 can be screened, but must be treated and recovered to CNS-1 before lymphodepleting chemotherapy and infusion);
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Timeframe: 1 month
2
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
✕. Transformation of chronic myeloid leukemia to acute biphenotypic leukemia;
✕. Individuals who have received CAR-T therapy or other gene modified cell therapies;
✕. Prior to apheresis, the following anti-tumor treatments have been received: chemotherapy, targeted therapy, and other drug treatments within 14 days or at least 5 half lives (whichever is shorter); Received radiation therapy within 14 days;
✕. HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive; CMV DNA positive;HBsAg or HBcAb positive and HBV DNA is greater than the normal range; HCV antibody is positive and HCV RNA greater than the normal range; HIV antibody positive; syphilis positive;
✕. Suffered from any of the following heart diseases:
✕. New York Heart Association (NYHA) stage III or IV congestive heart failure;