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Dose Optimization Trial of CD19 Redirected Autologous T Cells

NCT01747486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-06-22

Study results available
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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.

Conditions

  • Adult Patients Who Have Relapsed or Refractory CLL (3rd Line) or SLL

Interventions

BIOLOGICAL

CART-19

CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)

Sponsors & Collaborators

Principal Investigators

  • Noelle Frey, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-02
Primary Completion
2017-12-13
Completion
2018-04-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01747486 on ClinicalTrials.gov