CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 10 enrolled
Drug / intervention
single dose of CNCT19biological
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/NCT04230473
NCT04230473Phase 1Completed
CompareCT.gov

A Clinical Trial of CNCT19 Cells in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

Juventas Cell Therapy Ltd.·interventional·Posted Jan 18, 2020·Updated Mar 28, 2023

In Brief

A Phase 1 clinical trial evaluating single dose of CNCT19 for Relapsed or Refractory Acute Lymphoblastic Leukemia. Completed, enrolled 10 participants across 2 sites.

Detailed Summary

This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory acute lymphoblastic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed or Refractory Acute Lymphoblastic Leukemia
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedJan 18, 2020
Enrollment StartMar 13, 2020
Primary CompletionDec 1, 2020
Study CompletionNov 1, 2022
TodayJul 1, 2026
Enrollment to primary: 9 monthsPosted 6.5 years ago

Interventions

single dose of CNCT19biological

Dose A: 0.25 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide Dose B: 1.00 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide Dose C: 2.00 x 10\^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide