Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research
This study tests a new type of CAR-T cell therapy called Meta10-19, which are immune cells specially engineered to fight CD19-positive blood cancers. These cells are designed with special metabolic features to work better and longer in the body. The trial evaluates whether this approach is safe and effective for patients whose leukemia or lymphoma has come back or stopped responding to previous treatments.
Key Objective: This trial is testing whether metabolically enhanced CAR-T cells can improve treatment outcomes and durability in patients with relapsed or refractory CD19-positive blood cancers.
Who to Consider: Patients with acute lymphoblastic leukemia or other CD19-positive B cell blood cancers that have relapsed or are resistant to standard treatments should consider this trial.
Trial Parameters
Brief Summary
A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies
Eligibility Criteria
Inclusion Criteria: 1. Age range: 6 months to 18 years old, inclusive, for both males and females. 2. The patient or their guardian voluntarily signed the informed consent. 3. Patients with relapsed or refractory CD19-positive B cell hematological malignancies: 1. Relapsed or refractory B-ALL (meeting one of the following conditions): * Patients who relapse within 30 months after the initial remission, with \>5% primordial cells (lymphoblast and prolymphocyte) in bone marrow morphology, confirmed by flow cytometry. * Patients who relapse 30 months after the initial remission and fail to achieve complete remission or show poor response to early treatment after one course of standardized induction therapy. * Patients who relapse after allogeneic hematopoietic stem cell transplantation (HSCT) and must undergo screening 3 months post-HSCT . * Patients who do not achieve CR after standardized chemotherapy, or have \>1% minimal residual disease (MRD) in bone marrow after 3 months of chemothe