Colorectal CancerPhase 1NCT04107142
Haplo / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells for Relapsed or Refractory Solid Tumour
A Phase 1 study testing Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell in people with Colorectal Cancer and Triple Negative Breast Cancer, run by CytoMed Therapeutics Pte Ltd at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Triple Negative Breast Cancer, Sarcoma
- What is being tested?
- Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2019to 1 Mar 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women ≥18 years old.
- Patient with specific cancer indications (see below).
- Disease must be measurable according to the corresponding guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
- Patient with adequate bone marrow reserve (Haemoglobin ≥10g/dl, Absolute Neutrophil Count (ANC)≥1,500/mm3, Platelet≥100,000/mm3), hepatic function (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 3x upper limit of normal), renal function (serum creatinine < 120 µmol/L) and cardiac function (Left ventricular ejection fraction of ≥50% by ECHO).
- Patient must already have a previous tumour biopsy to confirm the disease.
Show all 11Show fewer
- Patient must agree to sign the informed consent form (ICF).
- Cancer-specific inclusion criteria of subject:
- Colorectal cancer: A documented metastatic colorectal adenocarcinoma and having received, being intolerant to or being unfit for at least two prior standard cancer therapy regimens as part of their primary treatment regimen or part of their treatment for management of recurrent/persistent disease.
- Breast cancer: A metastatic triple-negative breast cancer and having received at least two prior cancer therapy regimens as part of their treatment for management of recurrent/persistent disease.
- Sarcoma, nasopharyngeal cancer, prostate cancer or gastric cancer: A metastatic cancer and having received at least two prior cancer therapy regimens as part of their treatment for management of recurrent/persistent disease.
Who cannot join
- Patients with a tumour metastasis in the central nervous system.
- Patients who receive or are to receive any investigational product within the 4 weeks before the planned day for the first CTM-N2D administration.
- Patients who receive or are to receive chemotherapy within the 8 weeks before the planned day for the first CTM-N2D administration.
- Patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent.
- Patients who underwent major surgery within 4 weeks before the planned day for the first CTM-N2D administration.
- Patients who have active infections necessitating the use of antibiotics/antivirals treatment.
- Patients with a history of autoimmune disease.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Landmark Medical Centre
Johor Bahru, Johor, 80000
Lucas Luk, drlucas@landmarkmedical.com.my
Wee Kiat Tan, weekiattan@cytomed.sg
About this study
Official title: 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
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.
Read the 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
- Being tested
- Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell
- Keywords
- NKG2D, gamma, delta, T cell, CAR, chimeric antigen receptor, solid tumour, cancer immunotherapy, adoptive cell transfer
- Medical subject headings
- Colorectal Neoplasms, Triple Negative Breast Neoplasms, Sarcoma, Nasopharyngeal Carcinoma, Prostatic Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cellBiological
Adoptive Cell Transfer of Haploidentical / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D)
| Study group | Role | What they receive |
|---|---|---|
| CAR-T Cell Therapy Group | Experimental | 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. Receives: Biological: Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CytoMed Therapeutics Pte Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107142
- Sponsor's protocol ID
- CTM-N2D
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04107142
- Acronym / sponsor ID
- CTM-N2D
- Conditions
- Colorectal Cancer, Triple Negative Breast Cancer, Sarcoma, Nasopharyngeal Carcinoma, Prostate Cancer, Gastric Cancer
- Keywords
- NKG2D, gamma, delta, T cell, CAR, chimeric antigen receptor, solid tumour, cancer immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- CytoMed Therapeutics Pte LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CAR-T Cell Therapy Group | Experimental | Biological: Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cellOne 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men or women ≥18 years old.
- Patient with specific cancer indications (see below).
- Disease must be measurable according to the corresponding guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.
- Patient with adequate bone marrow reserve (Haemoglobin ≥10g/dl, Absolute Neutrophil Count (ANC)≥1,500/mm3, Platelet≥100,000/mm3), hepatic function (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) < 3x upper limit of normal), renal function (serum creatinine < 120 µmol/L) and cardiac function (Left ventricular ejection fraction of ≥50% by ECHO).
Key exclusion criteria (7 listed)
- Patients with a tumour metastasis in the central nervous system.
- Patients who receive or are to receive any investigational product within the 4 weeks before the planned day for the first CTM-N2D administration.
- Patients who receive or are to receive chemotherapy within the 8 weeks before the planned day for the first CTM-N2D administration.
- Patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent.
- Patients who underwent major surgery within 4 weeks before the planned day for the first CTM-N2D administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cellAdoptive Cell Transfer of Haploidentical / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D) | Biological | CAR-T Cell Therapy Group |
Primary outcome
Number of Patients with Dose Limiting Toxicity
Time frame: 6 months
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.
4 secondary outcomes
Occurence of adverse events during therapy
Time frame: 6 months
Observation of clinical efficacy
Time frame: 6 months to 2 years
Observation for progression-free survival
Time frame: up to 2 years
Observation for duration of response
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell in people with Colorectal Cancer and Triple Negative Breast Cancer, run by CytoMed Therapeutics Pte Ltd at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Choo (+65 9732 8844, peterchoo@cytomed.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Dose Limiting Toxicity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.