NCT03366350

Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies

A Phase 1/2 Study Evaluating the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-Modified T Cell (CAR-T) Therapy Bridging to Hematological Stem Cell Transplantation (HSCT) for Relapsed/Refractory CD19+ B-Cell Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Wuhan Sian Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This is the second stage of the previous anti-CD19 CAR-T therapy (NCT02965092). The study aims to evaluate the safety and efficacy of consolidative allo-HSCT following CAR-T therapy in patients with relapsed or refractory B cell Malignancies.

Detailed description

Anti-CD19 CAR-T therapy has been confirmed effective for relapsed/refractory B-cell malignancies. However, its ability to keep patients in maintained remission is limited. In order to keep patients in long-term remissions, patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.

Conditions

• Acute Lymphoblastic Leukemia
• B Cell Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Allogeneic hematological stem cell transplantation	Patients receive allogeneic hematological stem cell transplantation after they achieve MRD- CR through CAR-T therapy.

Timeline

• Start date: 2016-04-15
• Primary completion: 2021-01-01
• Completion: 2021-06-01
• First posted: 2017-12-08
• Last updated: 2019-05-10

Locations

1 site across 1 country: China