Trials / Unknown
UnknownNCT04107142
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- CytoMed Therapeutics Pte Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Colorectal Cancer
- Triple Negative Breast Cancer
- Sarcoma
- Nasopharyngeal Carcinoma
- Prostate Cancer
- Gastric Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell | Adoptive Cell Transfer of Haploidentical / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D) |
Timeline
- Start date
- 2019-12-01
- Primary completion
- 2020-09-01
- Completion
- 2021-03-01
- First posted
- 2019-09-27
- Last updated
- 2019-09-27
Locations
1 site across 1 country: Malaysia
Source: ClinicalTrials.gov record NCT04107142. Inclusion in this directory is not an endorsement.