Phase I Clinical Trial Evaluating the Safety and Efficacy of Point-of-care CAR-T-cell Therapy in the Treatment of Relapsed/Refractory CD19+ Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia
Overview
- Phase
- Phase 1
- Intervention
- anti-CD19 CAR T-cells
- Conditions
- B-Cell Non Hodgkin Lymphoma
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Assessment of the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
- Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells expressing CD19-specific chimeric antigen receptor (CAR).
- Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
- Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
- Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.
Detailed Description
Objectives: * Evaluate the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy. * Evaluate the response rate after CD19 CAR T-cell infusion according to the following criteria: * Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion * Progression-free survival (PFS) after infusion of CD19 CAR T-cells * Event-free survival (EFS) after infusion of CD19 CAR T-cells * Overall survival (OS) after infusion of CD19 CAR T-cells
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment Regimen
* Experimental: Treatment Regimen. * Leukapheresis to collect white blood cells using Spectra Optia Apheresis system. * T cells selection, transduction, and CAR T-cell manufacturing using CliniMACS Prodigy. During this process, T cells will be genetically modified to express CD19 CAR. * Lymphodepleting chemotherapy conditioning regimen for 3 days. * CAR T-cells targeting CD19 will be infused intravenously at a dose between 1 and 2x10e6 cells/kg for 15-30 minutes. * Following the T-cell infusion, patients will stay in the clinic for approximately 21-28 days to monitor toxicity. * Outpatient follow-up will take place after 1 month, 3 months, and 6 months after infusion.
Intervention: anti-CD19 CAR T-cells
Outcomes
Primary Outcomes
Assessment of the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy
Time Frame: 6 months
The incidence of adverse events (AEs) and serious adverse events (SAEs) will be recorded and classified according to CTCAE v5 (grade 1-5). CRS and ICANs will be classified using the ASTCT criteria (grade 1-5). These parameters will be used to assess the safety of the therapy.
Secondary Outcomes
- Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion (%)(Day 30 and day 90 after CAR-T infusion for B-ALL; day 90 after CAR-T infusion for NHL)
- Progression-free survival (PFS) (months)(6 months)
- Event-free survival (EFS) (months)(6 months)
- Overall survival (OS) (months)(6 months)