NCT02924753

The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).

The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Acute Lymphoblastic Leukemia.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 4 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.

Detailed description

Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects. Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
DRUG	Fludarabine	Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).
BIOLOGICAL	CART-19 cells	CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.

Timeline

• Start date: 2016-07-18
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2016-10-05
• Last updated: 2017-12-29

Locations

1 site across 1 country: China