This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status.Primary endpoints include treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), pharmacokinetics, and pharmacodynamics of UCAR-T. This study aims to provide initial evidence for the safety and anti-tumor activity of UCAR-T in CD19+/BCMA+ hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Patients will receive lymphodepletion chemotherapy followed by a single intravenous infusion of Allogeneic CAR-T cells. In select cases, CAR-T infusion may be administered post-autologous hematopoietic stem cell transplantation (auto-HSCT)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
TEAEs and DLTs will be graded according to CTCAE v5.0 and ASTCT consensus criteria
Time frame: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 months post-treatment.
Objective Response Rate (ORR)
Identify the number of patients with complete response (CR), Identify the number of patients with partial response (PR), and Calculate ORR=(CR+PR)/total patients
Time frame: Week 4, Month 3, Month 6 and Month 12
Disease control rate (DCR)
Identify the number of patients with complete response (CR), partial response (PR), stable disease (SD) and calculate DCR=(CR+PR+SD)/total patients
Time frame: Week 4, Month 3, Month 6 and Month 12
Progression-free survival (PFS)
PFS defned as the time from the date of RN1201 infusion to the frst assessment of confrmed disease progression or death
Time frame: Week 4, Month 3, Month 6 and Month 12
Overall survival (OS)
OS defned as the time from the date of RN1201 infusion to death
Time frame: Week 4, Month 3, Month 6 and Month 12
Cmax of RN1201
peak plasma concentration of CAR - T cells copy number and the positive rate
Time frame: Up to 12 months
Tmax of RN1201
Time to maximum concentration of RN1201
Time frame: Up to 12 months
Cytokines in the peripheral blood after RN1201 infusion
Serum concentrations of interleukin (IL)-2, IL-6, IL-8, IL-10, interferon-gamma (IFN-γ), and TNF-α
Time frame: Up to 12 months
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