CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 enrolled
Drug / intervention
CD19 CAR 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/NCT02975687
NCT02975687Phase 1Completed
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CD19 CAR T Cells in Patients With Resistant or Refractory CD19+ Acute Lymphoblastic Leukemia

Institute of Hematology & Blood Diseases Hospital, China·interventional·Posted Nov 29, 2016·Updated Jun 3, 2025

In Brief

A Phase 1 clinical trial evaluating CD19 CAR T cells for Acute Lymphoblastic Leukemia, Adult B-Cell and Acute Lymphoblastic Leukaemia Recurrent. Completed, enrolled 20 participants across 1 site.

Detailed Summary

In this single-center, open-label, no control, prospective clinical trial, a total of 20 resistant or refractory CD19+ B cell acute lymphoblastic leukemia (ALL) patients will be enrolled. CD19 CAR T cells will be administered by i.v. injection as a using a "split dose" (total dose of 5x10\^6/kg-5x10\^7/kg) approach to dosing:10% on day 0, 30% on day 1 and 60% on day 2. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells in patients with chemotherapy resistant or refractory CD19+ ALL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia, Adult B-Cell, Acute Lymphoblastic Leukaemia Recurrent
CountriesChina
CollaboratorsJuventas Cell Therapy Ltd.

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 29, 2016
Enrollment StartNov 1, 2016
Primary CompletionDec 1, 2018
Study CompletionDec 31, 2018
TodayJul 1, 2026
Enrollment to primary: 2.1 yearsPosted 9.6 years ago

Interventions

CD19 CAR T cellsbiological

CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.