OncoMatch/Clinical Trials/NCT05302037
Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)
Is NCT05302037 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D) for cancer.
Treatment: Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D) — CAR-T is a pioneering cancer treatment which has found success in some cancers. This treatment is made first by taking blood cells from the patient. Then in the lab, an artificial protein - a Chimeric Antigen Receptor (CAR), is grafted on the surface of immune cells. The modified cells, which are readministered to the patient, have enhanced abilities to target and destroy cancers than unmodified immune cells. Currently approved CAR-T can only be used autologously. i.e. the patient will receive CAR-T treatment made from their own cells. This is because current CAR-T treatment uses αβ T cells - a type of immune cell which are largely non-transferable between individual human beings due to the high risk of Graft-versus-Host Disease. However, autologous CAR-T comes with many limitations. A lengthy, manufacturing process follows after the patient donates their own blood, accompanied by a high risk of manufacturing failure, which can be attributed to the cell quality from cancer patients undergoing stressful anti-cancer therapy. CytoMed Therapeutics pioneers a new CAR-T treatment (CTM-N2D) which may confer some benefit over current CAR-T treatment. CTM-N2D uses a subtype of immune cell -- γδ T cell. Secondly, the CAR on CTM-N2D targets a surface antigen called NKG2DL which are commonly present in many cancer. These two features may confer a safer product profile, of better quality and may be efficacious in cancers where previous CAR-T treatments has not. The phase I clinical trial of CTM-N2D will be conducted at the National University Hospital, Singapore. The objective of this clinical trial is to determine the optimal dose of CTM-N2D, and to investigate its safety and tolerability. The subjects of the clinical trial will also be investigated for their tumour response to CTM-N2D. CTM-N2D has undergone preclinical studies. Relevant data from other clinical trials are also used to infer the expected outcome, and strategies of management of this clinical trial. The institution's ethical review board must give its approval before the study may begin. An independent Data Safety Monitoring Board monitors the safety aspect of this trial.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard cancer therapy — recurrent/persistent/metastatic
resistant to or deemed unsuitable for at least two standard lines of cancer therapy regimens
Cannot have received: investigational product
Receiving, or having received during the four weeks prior the start of lymphodepletion, any investigational product
Cannot have received: investigational biological product (immune check point blockers, antibodies, nanoparticles, experimental)
Treatment with any investigational biological product (e.g., immune check point blockers, antibodies, nanoparticles, experimental) during the four weeks prior the start of lymphodepletion
Cannot have received: radiation therapy
Exception: planned or ongoing palliative radiation to bone outside of the region of measurable disease
Radiation (except planned or ongoing palliative radiation to bone outside of the region of measurable disease) during the three weeks prior to the start of Lymphodepletion
Cannot have received: major surgery
Patients who underwent major surgery during the four weeks prior to the start of lymphodepletion
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.0x10^9/L; Platelet count ≥ 75 x 10^9/L; Haemoglobin ≥ 9.0 g/dL
Kidney function
Glomerular filtration rate (GFR) > 50 mL/min, as assessed using the Cockroft-Gault formula or 24 h urine creatinine collection
Liver function
AST or ALT ≤ 3 x ULN; Total bilirubin ≤ 1.5 x ULN
Cardiac function
Myocardial infarction within six months of study entry, NYHA Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias or reduced LVEF < 50%. Mean resting corrected QT interval (QTc) > 470 msec. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block). Uncontrolled hypertension requiring clinical intervention.
Adequate hepatic, renal and lung function as demonstrated by any of the following laboratory values: AST or ALT ≤ 3 x ULN; Total bilirubin ≤ 1.5 x ULN; Glomerular filtration rate (GFR) > 50 mL/min; SpO2 on room air > 94%. Adequate bone marrow reserve as demonstrated by any of the following laboratory values: ANC ≥ 1.0x10^9/L; Platelet count ≥ 75 x 10^9/L; Haemoglobin ≥ 9.0 g/dL. Cardiac dysfunction as defined as: Myocardial infarction within six months of study entry, NYHA Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias or reduced LVEF < 50%. Any of the following cardiac criteria: Mean resting corrected QT interval (QTc) > 470 msec; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block); Uncontrolled hypertension requiring clinical intervention.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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