CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
Adult differentiated autologous T-cellsbiological
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/NCT03144583
NCT03144583Phase 1Completed
CompareCT.gov

Pilot Study on the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-CD19 Specificity Conjugated With the Co-stimulatory Regions 4-1BB and CD3z in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy

Sara V. Latorre·interventional·Posted May 9, 2017·Updated Aug 28, 2023

In Brief

A Phase 1 clinical trial evaluating Adult differentiated autologous T-cells for Leukemia and Lymphoma. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity \[A3B1\] conjugated with the co-stimulatory regions 4-1BB and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to treatment and with a prognosis of less than 2 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Lymphoma
CountriesSpain
CollaboratorsInstituto de Salud Carlos III

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 9, 2017
Enrollment StartJun 15, 2017
Primary CompletionSep 13, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.1 years ago

Interventions

Adult differentiated autologous T-cellsbiological

After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.