CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 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/NCT02030834
NCT02030834Phase 2Completed
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Phase IIa Study of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCRz and 4-Signaling Domains in Patients With Chemotherapy Relapsed or Refractory CD19+ Lymphomas

University of Pennsylvania·interventional·Posted Jan 9, 2014·Updated Jun 22, 2023

In Brief

A Phase 2 clinical trial evaluating CART-19 for Non-Hodgkins Lymphoma (NHL) Patients, With CD19+B Cell Lymphomas. Completed, enrolled 63 participants across 1 site.

Detailed Summary

Phase IIa study to estimate the efficacy of a single infusion of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as CART-19 or CTL019 cells) in non-Hodgkins Lymphoma (NHL) patients. The duration of active protocol intervention is approximately 24 months from screening visit. The protocol will require approximately 48 months to complete.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkins Lymphoma (NHL) Patients, With CD19+B Cell Lymphomas
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 9, 2014
Enrollment StartFeb 5, 2014
Primary CompletionSep 16, 2019
Study CompletionSep 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 12.5 years ago

Interventions

CART-19biological

Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).