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One arm study consisting of "3 + 3" dose escalation study design ranging from 3 x 10\^8 - 3 x 10\^9 cells CAR-γδ T cell.

Each cycle of therapy will consist of 4 intravenous infusions, given 7 days apart.

Adoptive Cell Transfer of Haploidentical / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D)

Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell

Peter Choo

Wee Kiat Tan

Lucas Luk

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.

The study consisT of "3 + 3" dose escalation study design with 3 distinct dose level.

The first dose level will be at 3 x 10\^8 chimeric antigen receptor (CAR) grafted γδ T cells per infusion.

The second dose level will be at 1 x 10\^9 CAR-γδT cells per infusion. The third dose level will be increased to 3 x 10\^9 cells CAR-γδT cells.

Each cycle of therapy will consist of 4 intravenous infusions, given 7 days apart.

Haplo / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells for Relapsed or Refractory Solid Tumour

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

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.

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

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)

A secondary outcome is to observe for progression-free survival (PFS) and after the start of 1st cycle of treatment

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Haplo / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells for Relapsed or Refractory Solid Tumour	NCT04107142	Colorectal Canc... Triple Negative... Sarcoma Nasopharyngeal ... Prostate Cancer Gastric Cancer	Adoptive Cell T...	18 Years -	CytoMed Therapeutics Pte Ltd
Haplo / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells for Relapsed or Refractory Solid Tumour	NCT04107142	Colorectal Canc... Triple Negative... Sarcoma Nasopharyngeal ... Prostate Cancer Gastric Cancer	Adoptive Cell T...	18 Years -	CytoMed Therapeutics Pte Ltd

Spots Global Cancer Trial Database for delta

Every month we try and update this database with for delta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for delta

Every month we try and update this database with for delta cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for delta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.