Clinical Trials Directory

Trials / Unknown

UnknownNCT02685670

Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T Cells for B-cell Leukemia/Lymphoma

A Phase I/II Study of Competitive Transfer of αCD19-TCRz-CD28 and αCD19-TCRz-CD137 Chimeric Antigen Receptor T-Cells in Patients With Refractory CD19+ B-lineage Leukemia/Lymphoma

Status
Unknown
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine · Academic / Other
Sex
All
Age
5 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This is a single-arm open-label phase I/II study to determine the relative superiority of αCD19-TCRζ-CD28 and αCD19-TCRζ-CD137 CAR-T Cells in safety, efficacy and engraftment potential in patients with CD19+ B-lineage leukemia and lymphoma. Recently, cancer immunotherapy, treatments aiming to arm patients with immunity specifically against cancer cells, has emerged as a promising therapeutic strategy. Clinical trials utilizing CARs against B cell malignancies have demonstrated remarkable potential. In this trial, all subjects will be competitively infused with αCD19-TCRz-CD28 and αCD19-TCRz-CD137 CAR-T cells in equal number to test a hypothesis that CD137-costimulation can promote the persistence and engraftment of CAR-T cells and this superiority can lead to improved progression-free survival.

Detailed description

Primary objectives 1\. To determine the safety and feasibility of adoptive transfer of T cells modified to express CD19-specific chimeric antigen receptor (CD19CAR) for treatment of leukemia and lymphoma Secondary objectives 1. To measure the efficacy of anti-tumor responses after CD19CAR T cell infusion 2. To determine if CD19CAR T cells engineered with 4-1BB signaling domain is superior to that with CD28 signaling domain for their homing and persistence after CD19CAR T cell infusion

Conditions

Interventions

TypeNameDescription
BIOLOGICALanti-CD19 CAR-TEx vivo-expanded autologous T cells modified to express CD19 CAR
DRUGFludarabine
DRUGCyclophosphamide

Timeline

Start date
2016-02-01
Primary completion
2017-12-01
Completion
2019-12-01
First posted
2016-02-19
Last updated
2017-03-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT02685670. Inclusion in this directory is not an endorsement.