NCT03110640

Anti-CD19 CAR T Infusion Combined With Allogeneic Stem Cell Transplantation for B-cell Leukemia/Lymphoma

A Phase I Study of Administrating CD19 Chimeric Antigen Receptor Expressing T Cells Followed by Allogeneic Stem Cell Transplantation in Patients With Refractory CD19+ B-linage Leukemia/Lymphoma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 5 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm open-label phase I study to determine the effect of CD19- CAR-T Cells infusion followed by allogeneic stem cell transplantation in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma.

Detailed description

Primary objectives 1. To determine the safety and feasibility of allogeneic stem cell transplantation combined with adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives 2. To measure the efficacy of the CD19CAR T cell infusion combined with allogeneic stem cell transplantation

Conditions

• B-cell Adult Acute Lymphoblastic Leukemia
• B-cell Chronic Lymphocytic Leukemia
• Adult Acute Lymphoblastic Leukemia in Remission
• Hematopoietic/Lymphoid Cancer
• Refractory Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	anti-CD19 CAR-T	Ex vivo-expanded autologous T cells modified to express CD19 CAR
DRUG	Fludarabine	Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.
DRUG	Cyclophosphamide	Patients were given cyclophosphamide 500mg/m2/day on day -4.

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-06-01
• Completion: 2021-09-01
• First posted: 2017-04-12
• Last updated: 2019-11-27

Locations

1 site across 1 country: China