Prostate Cancer Clinical Trial
Official title:
A Phase I Dose-escalation Trial to Evaluate Haploidentical / Allogeneic Natural Killer Group 2D Ligand (NKG2DL)-Targeting Chimeric Antigen Receptor-grafted Gamma Delta (γδ) T Cells (CTM-N2D) in Subjects With Relapsed or Refractory Solid Tumour
This clinical trial is an open-label, single-centre, dose escalation, phase I study designed to investigate the safety and tolerability of Haploidentical / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted Gamma Delta (γδ) T Cells (CTM-N2D) in Subjects with Relapsed or Refractory Solid Tumour. The study objectives of this phase I study are to determine the safety, activity and the safe dose of haploidentical or allogeneic NKG2DL-targeting chimeric antigen receptor-grafted γδ T cells given four times weekly in patients with relapsed or refractory solid tumors of different types.
CTM-N2D-101 is a phase I dose-escalation study to evaluate the safety of CTM-N2D and the
feasibility to produce CTM-N2D for three target dose levels between 3x10^8 - 3x10^9 per
infusion will be tested. Four doses will be given at an interval of a week into subjects with
relapsed or refractory solid tumors.
A typical 3+3 design will be used to determine the safe regimen basing on the incidence of
dose-limiting toxicity (DLT). The identified safe regimen will be used for further phase II
studies for selected indications.
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