Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Precision Biotech Co., Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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;
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;
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);
Disqualifiers
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);
Transformation of chronic myeloid leukemia to acute biphenotypic leukemia;
Individuals who have received CAR-T therapy or other gene modified cell therapies;
Trial design
Treatments tested in this trial
- MC-1-50
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Chongqing Precision Biotech Co., Ltd
Lead sponsor
Ruijin Hospital
Collaborator
Source ClinicalTrials.gov