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.
Study Type
INTERVENTIONAL
Purpose
OTHER
Masking
NONE
Enrollment
10
Adoptive Cell Transfer of Haploidentical / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D)
Landmark Medical Centre
Johor Bahru, Johor, Malaysia
Number of Patients with Dose Limiting Toxicity
The primary endpoint of this dose-escalation study will be the occurrence of dose-limiting toxicities (DLTs) during 4 cycles of treatment and the week after treatment.
Time frame: 6 months
Occurence of adverse events during therapy
A secondary outcome is to observe for the occurence of any adverse events (AEs) and serious adverse events (SAEs) during 4 cycles of treatment and the week after treatment
Time frame: 6 months
Observation of clinical efficacy
A secondary outcome is to observe for the occurrence of objective clinical response at d31, M3, M6, M9, M12, M18 and M24 after the start of 1st cycle of treatment (assessed according to RECIST criteria, version 1.1)
Time frame: 6 months to 2 years
Observation for progression-free survival
A secondary outcome is to observe for progression-free survival (PFS) and after the start of 1st cycle of treatment
Time frame: up to 2 years
Observation for duration of response
A secondary outcome is to observe the duration of response in patients with objective response up to M24, After the start of 1st cycle of treatment
Time frame: Up to 2 years
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