CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Infusion of modified CAR19 T-cells (4G7-CARD T-cells)genetic
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/NCT02893189
NCT02893189Phase 1Completed
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Chimeric Antigen Receptor (CAR)19 Donor Lymphocytes for Relapsed Cluster of Differentiation (CD)19+ Malignancies Following Allogeneic Transplantation (CARD)

University College, London·interventional·Posted Sep 8, 2016·Updated Jun 22, 2023

In Brief

A Phase 1 clinical trial evaluating Infusion of modified CAR19 T-cells (4G7-CARD T-cells) for CD19+ Malignancies: Relapse Post-allogeneic Transplant. Completed, enrolled 17 participants across 1 site.

Detailed Summary

Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels planned. Patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually for years 2 and 3.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCD19+ Malignancies: Relapse Post-allogeneic Transplant
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 8, 2016
Enrollment StartApr 27, 2017
Primary CompletionDec 31, 2019
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.8 years ago

Interventions

Infusion of modified CAR19 T-cells (4G7-CARD T-cells)genetic

The original stem cells donor (or if not available the patient) will undergo unstimulated leucapheresis for generation of the Advanced Therapy Interventional Medicinal Product (ATIMP) 4G7-CARD T-cells. Escalating doses of the ATIMP will then be infused to the patient depending on outcome and any experienced side effects.