Bispecific CD19/CD22 CAR-T for Treatment of Children and Young Adults With r/r B-ALL

B-ALL Clinical Trial

Official title: Safety and Efficiency of Anti-CD19/CD22 Tandem Fully Human Chimeric Antigen Receptor (CAR)-Transduced T-cell Therapy for Pediatric and Young Adult Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia: a Single Centre, Non-randomised, Open Label Phase I-II Clinical Trial of Automatically Produced Cell Therapy Product MB-CAR-T19-22 Using CliniMACS Prodigy

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficiency of autologous CD19/CD22 CAR-T lymphocytes in a cohort of pediatric and young adult patients with relapsed /refractory B-lineage acute lymphoblastic leukemia

Clinical Trial Description

The main objectives of the study are:

• To investigate the incidence of adverse events of grade 3-5 within after CD19/CD22 CAR lymphocyte infusion by day 28,

• To evaluate the incidence of complete remission and MRD-negative CR by day 28

• To evaluate the long-term effectiveness of CD19/CD22 CAR-T therapy (cumulative incidence of relapse, event-free survival, overall survival) at 1, 2, and 5 years after infusion.

• To evaluate the persistence of CD19/CD22 CAR-T cells and duration of B-cell aplasia (<1% B-cells in the blood) and hypogammaglobulinemia In order to prevent the development of CRS, all patients will receive an infusion of tocilizumab at 8 mg/kg body weight on day 0 before CAR-T cells infusion.

Step-down and step-up dosing will be used to adapt the trial to the scenario of excess toxicity and/or suboptimal effect. Reevaluation of dosing will be done for each cohort separately after the enrollment 5th study subject reaches day 28 or earlier if the threshold for excess toxicity or suboptimal effect is achieved.

Based on interim analysis in March 2021 after the enrollment 5th study subject reaches day 28 study population will be divided into three cohorts:

1. CD19-positive (both CD19 and CD22 expressed on over 50% of leukemia cells), low and high disease burden.

2. CD19-negative (CD22 expressed on over 50% of leukemia cells) low and high disease burden;

3. Allogeneic HSCT+ allogeneic CAR-T cohort ;

Related Conditions & MeSH terms

• B-ALL

• NCT number: NCT04499573
• Study type: Interventional
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 27, 2020
• Completion date: March 13, 2027