NCT07162571

This is a Phase I/II Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19/22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma.

Phase I/II Open-label Study Evaluating The Safety And Efficacy of Anti CD19/22 CAR-T Cells Therapy Adults With R/ R Leukemia/ Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (estimated)
• Sponsor: Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to estimate the safety and the efficacy of anti-CD19/22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.

Detailed description

Locally manufactured second generation autologous CD19/22 CAR-T cells are used for immunotherapy. Protocol treatment includes leukapheresis in order to harvest T cells, lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one dual targeting CAR-T cells infusion. The Main research objectives of the Phase I: To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability. The Secondary research objectives of the Phase I: To explore the pharmacokinetics of CAR-T cells. The Main research objectives of the Phase II: Overall response rate, including complete response (CR) and partial response (PR) rates. The Secondary research objectives of the Phase II: Duration of response (DOR). Progression-free survival rates. Overall survival rates.

Conditions

• Acute Lymphobkastic Leukemia
• B Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CD19/22 CAR-T cells	Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 150 x 10⁶ CD19/CD22 CAR-T cells

Timeline

• Start date: 2026-01-01
• Primary completion: 2030-12-01
• Completion: 2031-12-01
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: Belarus