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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02893189
Study type Interventional
Source University College, London
Contact CARD trial coordinator
Phone 0207 679 9644
Email ctc.card@ucl.ac.uk
Status Recruiting
Phase Phase 1
Start date April 27, 2017
Completion date October 2022