CD19+ Malignancies: Relapse Post-allogeneic Transplant Clinical Trial
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
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 without pre-conditioning,
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 will be at least 28 days, following TMG confirmation. After the first 3 patients have received dose level 1 the Independent Data Management Committee will advise whether the inter-patient dosing interval for subsequent patients can be shortened.
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. ;
|Source||University College, London|
|Contact||CARD trial coordinator|
|Phone||0207 679 9644|
|Start date||April 27, 2017|
|Completion date||October 2022|