NCT02893189

CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation

Chimeric Antigen Receptor (CAR)19 Donor Lymphocytes for Relapsed Cluster of Differentiation (CD)19+ Malignancies Following Allogeneic Transplantation (CARD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• CD19+ Malignancies: Relapse Post-allogeneic Transplant

Interventions

Type	Name	Description
GENETIC	Infusion of modified CAR19 T-cells (4G7-CARD T-cells)	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.

Timeline

• Start date: 2017-04-27
• Primary completion: 2019-12-31
• Completion: 2022-12-31
• First posted: 2016-09-08
• Last updated: 2023-06-22

Locations

1 site across 1 country: United Kingdom