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CTM-N2D

Phase 1

Cancer | CAR-T | Oncology |CytoMed Therapeutics Limited|Trials Updated: Nov 22, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

CTM-N2D clinical trials

CTM-N2D · 1 trial · 4 indications

Phase 1 1
NCT05302037Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)Cancer
RECRUITING12 Analytics
PHASE1RECRUITING
Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine a dose regimen and schedule of CTM-N2D at which no more than one patient out of up to six patients at the same dose level experience a CTM-N2D-related DLT
Within 8 weeks immediately after the start of study treatment

Cohort 1: Three patients will be treated with four escalating doses of CTM-N2D to determine an optimal dose based on the incidence of DLT. DLT is defined as an unexpected grade 3 or 4 non-hematologic toxicity that is probably related to CTMN2D infusion and experienced within 8 weeks immediately after the start of study treatment. Treatments with maintenance doses of CTM-N2D will not be considered in determining DLT.

Number of Participants With Treatment-Related Adverse Events as assessed by NCI CTCAE v5.0
24 months after the start of study treatment

Cohort 2: Six patients will be treated with four infusions of CTM-N2D at the optimal dose determined in Cohort 1.

Secondary Endpoints

Maximum objective response rate according to RECIST v1.1
24 months after the start of study treatment
Progression-free survival (PFS)
Up to 48 months after the last patient was initiated for study treatment
Overall survival (OS)
Up to 48 months after the last patient was initiated for study treatment
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose-Escalation ArmEXPERIMENTALFour infusions of CTM-N2D at escalating doses: 1x10\^7, 1x10\^8, 3x10\^8 or 1x10\^9 per infusion at an interval of one infusion every 7 days.
Optimal Dose ArmEXPERIMENTALFour infusions of CTM-N2D at the optimal dose (expected to be 1x10\^9) at an interval of one infusion every 7 days.

Interventions

NameTypeDescription
Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D)BIOLOGICALIn the production of CTM-N2D, blood cells from healthy donors are used as starting materials. Through a proprietary expansion technology, γδ T cells of high-purity can be obtained. These γδ T cells are further grafted with NKG2DL-targeting CARs using mRNA electroporation to enhance its anticancer potency. The finished product (CTM-N2D) are then infused allogeneically into cancer patients.
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * At least 21 years of age * Provision of signed and dated, written informed consent prior to any study specific procedures, sampling, and analyses (if applicable, the written informed consent may include access to all archival tumour tissue, e.g., diagnostic and/or most recent ...

Countries:Singapore
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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about CTM-N2D

What is CTM-N2D?

CTM-N2D is an investigational allogeneic cell therapy being developed for advanced cancers. It is a CAR-grafted gamma delta T cell product designed to target NKG2DL. It is currently in Phase 1 clinical development and is not approved for any indication.

What is CTM-N2D used for?

CTM-N2D is being studied for the treatment of advanced cancers, including refractory and relapsed malignancies. The Phase 1 trial enrolls patients with cancer, malignancy, refractory cancer, or relapsed cancer. It is investigational and has not been approved for any use.

What does CTM-N2D target?

CTM-N2D targets NKG2DL, or NKG2D ligands, through a chimeric antigen receptor grafted onto gamma delta T cells. The product is allogeneic, meaning the T cells come from a donor rather than the patient. This NKG2DL-targeting approach is being evaluated in advanced cancers.

Who is developing CTM-N2D?

CTM-N2D is being developed by CytoMed Therapeutics Limited, which trades under the ticker GDTC. The company is advancing the allogeneic NKG2DL-targeting CAR-grafted gamma delta T cell therapy in a Phase 1 clinical trial.

What phase is CTM-N2D in?

CTM-N2D is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA or any regulatory authority. The ongoing Phase 1 trial is currently recruiting participants.

What clinical trials is CTM-N2D in?

CTM-N2D is being evaluated in a single Phase 1 trial, NCT05302037, titled Allogeneic NKG2DL-targeting CAR gamma delta T Cells (CTM-N2D) in Advanced Cancers (ANGELICA). The trial is recruiting up to 12 participants in Singapore and is controlled, non-randomized, and not double-blind.