CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
CART-19biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01747486
NCT01747486Phase 2Completed
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Dose Optimization Trial of Autologous T Cells Engineered to Express Anti-CD19 Chimeric Antigen Receptor (CART-19) in Patients With Relapsed or Refractory CD19+ Chronic Lymphocytic Leukemia (CLL)

University of Pennsylvania·interventional·Posted Dec 11, 2012·Updated Jun 22, 2023

In Brief

A Phase 2 clinical trial evaluating CART-19 for Adult Patients Who Have Relapsed or Refractory CLL (3rd Line) or SLL. Completed, enrolled 42 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Patients Who Have Relapsed or Refractory CLL (3rd Line) or SLL
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2012
Enrollment StartJan 2, 2013
Primary CompletionDec 13, 2017
Study CompletionApr 6, 2018
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 13.6 years ago

Interventions

CART-19biological

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