NCT03366324

Anti-CD19 CAR-T Therapy Combine With HSCT to Treat MRD+ B-cell Malignancies

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Wuhan Sian Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

For micro residual disease (MRD) positive patients who have undergone at least 2 cycles chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them to receive hematological stem cell transplantation (HSCT) than MRD- patients. In order to reduce HSCT-related adverse events for these kind of patients, investigators plan to conduct CAR-T therapies on them first to make them achieve MRD- statuses, and then transfer them to HSCT.

Detailed description

In order to improve prognoses for MRD+ patients who have undergone at least 2 cycles chemotherapies, patients will receive CAR-T therapy before HSCT, once they achieve MRD- remissions, they will subsequently receive HSCT if there are no contraindications.

Conditions

• Acute Lymphoblastic Leukemia
• B Cell Lymphoma

Interventions

Type	Name	Description
GENETIC	Second generation CAR-T cells	Patients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2.
PROCEDURE	Hematological stem cell transplantation	Patients receive hematological stem cell transplantations within 3 months after they achieve MRD- remissions after CAR-T therapies.

Timeline

• Start date: 2016-05-01
• Primary completion: 2021-01-01
• Completion: 2021-06-01
• First posted: 2017-12-08
• Last updated: 2018-11-20

Locations

1 site across 1 country: China