NCT04626726

Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation

A Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of CAR-T Cell in the Treatment of Adult Relapsed Refractory (R/R) Acute Lymphoblastic Leukemia Bridging Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

Detailed description

This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。

Conditions

• Adult B Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	CD19 CAR-T	CD19 CAR-T infusion for patients with CD19 positive tumor cells
DRUG	CD22 CAR-T	CD22 CAR-T infusion for patients with CD22 positive tumor cells
DRUG	CD19+CD22 CAR-T	CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
DRUG	Fludarabine	25mg/㎡ for D-4、D-3 and D-2
DRUG	Cyclophosphamide	500mg/㎡ for D-3 and D-2

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2020-11-13
• Last updated: 2020-11-13

Locations

1 site across 1 country: China