Loading clinical trials...
Loading clinical trials...
Chimeric Antigen Receptor (CAR)19 Donor Lymphocytes for Relapsed Cluster of Differentiation (CD)19+ Malignancies Following Allogeneic Transplantation (CARD)
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.
Patients will receive escalating doses of 4G7-CARD T-cells (after pre-conditioning with Fludarabine and Cyclophosphamide), paralleling clinical standard of care with unmanipulated donor lymphocytes. Intra-patient dose escalation will proceed at intervals of not less than 8 weeks, dependent on development of toxicity or evidence of efficacy and confirmation by the Trial Management Group. Three dose cohorts levels are planned, and dosing will be according to total CD3+ T- cell dose as this correlates with toxicity in the unmanipualated donor lymphocyte setting: * Dose Level 1: 1x10\^6 CD3+ T-cells/kg (starting dose for all patients) * Dose Level 2: 3x10\^6 CD3+ T-cells/kg * Dose Level 3: 1x10\^7 CD3+ T-cells/kg The inter-patient dosing for the first 3 patients was at least 28 days, following TMG confirmation. Patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4G7-CARD T-cell infusion. During the long term follow up phase of the study (years 2-3 post-final 4G7-CARD T-cell infusion) patients will be followed-up annually for overall survival, disease status and safety. All patients will enter long term follow up until 3 years post-final 4G7-CARD T-cell infusion.
Age
16 - 70 years
Sex
ALL
Healthy Volunteers
No
University College London Hospital
London, United Kingdom
Start Date
April 27, 2017
Primary Completion Date
December 31, 2019
Completion Date
December 31, 2022
Last Updated
June 22, 2023
17
ACTUAL participants
Infusion of modified CAR19 T-cells (4G7-CARD T-cells)
GENETIC
Lead Sponsor
University College, London
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions