Dose Optimization Trial of CD19 Redirected Autologous T Cells

Phase 2

Completed

• Conditions: Adult Patients Who Have Relapsed or Refractory CLL (3rd Line) or SLL
• Interventions: Biological: CART-19

• Registration Number: NCT01747486
• Lead Sponsor: University of Pennsylvania

Brief Summary

This is a randomized, open-label, parallel group study to determine the optimal dose of CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR Zeta and 4-1 BB co-stimulatory domains) of the two dose levels being assessed (1-5x10e8 vs. 1-5x10e7 CART-19 cells). This trial will be conducted in two stages.

Detailed Description

This study is being conducted to determine the optimal dose of autologous CART-19 T cells engineered to express anti-CD19 chimeric antigen receptors in patients with relapsed or refractory CD19 positive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The two dose levels being assessed are 1-5x10e8 versus 1-5x10e7. The trial will be conducted in two stages. In stage I subjects will be randomized into one of the two dose cohort with a1:1 ratio for a total of 12 subjects per dose cohort. Stage II will be to enroll an additional 8 subjects to the selected dose cohort once safety, tolerability and clinical responses have been evaluated to determine the optimal dose cohort.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-11
• Study Start: 2013-01-02
• Primary Completion: 2017-12-13
• Study Completion: 2018-04-06
• Results First Submitted: 2018-12-11
• Results First Submitted QC: 2019-02-25
• Results First Posted: 2019-02-26
• Status Verified: 2019-08
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Target dose of 1-5x10e8	CART-19	Arm 1: Target dose of 1-5x10e8 CART-19 cells (calculated as range of 10-50% transduced cells in 1 x10e9 total cells)
Target dose of 1-5x10e7	CART-19	Arm 2: Target dose of 1-5x10e7 CART-19 cells (calculated as the range of 10-50% transduced cells in 1 x10e8 total cells)

Primary Outcome Measures

Name	Time	Method
Number of Patients Achieving Complete Response Within 3 Months	3 months	Complete response (including complete response with incomplete marrow recovery) within 3 months (in evaluable patients). The eveluable set comprise of patients who have received CART19 at intended dose level and completed at least 3-month follow-up after the infusion or discontinued due to disease progression, new cancer therapy or death.

Trial Locations

Locations (1)

Abramsonc Cancer Center of The University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States