Trial Details
Trial status:
In follow-up (non-recruiting)
Recruitment start date:
Wellcome Trust (HICF)
Chief Investigator:
Dr Claire Roddie
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Immunotherapy using CAR T-cells to target CD19 for relapsed/refractory CD19+ Primary CNS Lymphoma
Design: A single centre, non-randomised, open label phase I clinical trial of an Advanced Therapy Investigational Medicinal Product (ATIMP) in patients 16 years and above with relapsed/refractory CD19+ Primary CNS Lymphoma. 
The ATIMP tested in this study is CD19CAT-41BBζ CAR T-cells (referred to as CD19CAR T-cells). These are Chimeric Antigen Receptor (CAR) T-cells genetically modified to recognise the CD19 protein present on the malignant cells and attack them.

A total of 12 patients will be treated at 1 participating site.
Treatment: Patients will undergo an unstimulated leucapheresis which will be sent to CCGTT-RFH for manufacture of CD19CAR T-cells.  ATIMP manufacture takes about 15 days. During this period, patients may receive “holding” chemotherapy to maintain disease control. Prior to CD19CAR T-cell infusion patients will receive iv cyclophosphamide 60mg/kg on Day-6 and iv fludarabine 30 mg/m2 on Days -5 to -3, followed by conditioning with i.v. pembrolizumab 200mg on Day-1.
The CD19CAR T-cells will be given in two themes. All patients will receive a single dose of 250 x 10^6 CD19CAR T-cells in theme 1 (intravenous infusion). 
Patients whose disease does not respond to this intravenous infusion (or comes back (relapses) later) and in the absence of toxicity, may receive a second dose of 25 x 10^6 CD19CAR T-cells infusion in theme 2 (intraventricular infusion delivered into the brain using Ommaya reservoir).
Patients will be followed up regularly (with daily, weekly and monthly visits) until 2 years post-CD19CAR T-cell infusion.  After 2 years patients will continue to be followed up annually until 10 years post ATIMP infusion.
Key inclusion/exclusion criteria: Age 16 or over; diagnosis of Relapsed or refractory CD19+ PCNSL.
Patients with active HepB, HepC or HIV infection; with evidence of secondary CNS lymphoma are excluded from the study. Bilirubin needs to be no more than 2xULN, ECOG must not be 3-4 and GFR must be
Duration of recruitment: Anticipated recruitment for the feasibility will be over 2 years.
The aim of the study is to evaluate the safety, efficacy and duration of response of the CAR T-cells in resistant or relapsed PCNSL.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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