Clinical Trials/NCT02135406

NCT02135406

Completed

Phase 1

Pilot Study Of Redirected Autologous T Cells Engineered To Contain Anti-CD19 Attached To TCRζ And 4-1BB Signaling Domains Coupled With Salvage Autologous Stem-Cell Transplantation (ASCT) In Multiple Myeloma Patients With Early Relapse/Progression After Initial ASCT

University of Pennsylvania1 site in 1 country13 target enrollmentMay 2014

ConditionsMultiple Myeloma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: University of Pennsylvania
Enrollment: 13
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary goals: determine the safety, tolerability and engraftment potential of CART-19 T cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB administered by intravenous infusion using a single infusion of 1-5x108 CART19-transduced T cells on day +2 after autologous stem cell infusion following high-dose melphalan.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

January 18, 2018

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: 2 years

Study Sites (1)

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