CD19 CAR T-Cell Therapy for R/R Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia
- Conditions
- B-Cell Acute Lymphoblastic LeukemiaB-Cell Non Hodgkin Lymphoma
- Interventions
- Biological: anti-CD19 CAR T-cells
- Registration Number
- NCT06027957
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Regimen anti-CD19 CAR T-cells * 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.
- Primary Outcome Measures
Name Time Method Assessment of the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy 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 Outcome Measures
Name Time Method 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 Patients with B-ALL will receive bone marrow biopsy assessed on day 30 and day 90 to check blast frequency and MRD. The response will be classified according to NCCN guidelines.
Patients with NHL will be examined PET-CT or CT on day 90. The response will be classified according to Cheson guidelines.Progression-free survival (PFS) (months) 6 months PFS is defined as the time from CAR T-cell infusion, until disease progression or death from any cause. Progression is defined as an increase of tumor load, the development of new lesions.
Event-free survival (EFS) (months) 6 months EFS is defined as time to treatment failure (including complete remission with incomplete hematologic or platelet recovery), relapse from complete remission, or death from any cause.
Overall survival (OS) (months) 6 months EFS is defined as time to death
Trial Locations
- Locations (1)
Vinmec Research Institute of Stem Cell and Gene Technology
🇻🇳Hanoi, Vietnam