CART-19 for Multiple Myeloma

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Biological: CART-19 T cells

• Registration Number: NCT02135406
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-08
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-12
• Primary Completion: 2015-09
• Study Completion: 2018-01-18
• Status Verified: 2018-02
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiple Myeloma Patients	CART-19 T cells	Adult subjects (18 years or older) with multiple myeloma and with poor prognosis by virtue of having relapsed/progressive disease within one year of first autologous stem cell transplantation.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	2 years

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States