- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04107142
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
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Peter Choo
- Phone Number: +65 9732 8844
- Email: peterchoo@cytomed.sg
Study Contact Backup
- Name: Wee Kiat Tan
- Phone Number: +65 9816 9085
- Email: weekiattan@cytomed.sg
Study Locations
-
-
Johor
-
Johor Bahru, Johor, Malaysia, 80000
- Landmark Medical Centre
-
Contact:
- Lucas Luk
- Email: drlucas@landmarkmedical.com.my
-
Contact:
- Wee Kiat Tan
- Email: weekiattan@cytomed.sg
-
Principal Investigator:
- Lucas Luk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CAR-T Cell Therapy Group
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurence of adverse events during therapy
Time Frame: 6 months
|
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
|
6 months
|
Observation of clinical efficacy
Time Frame: 6 months to 2 years
|
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)
|
6 months to 2 years
|
Observation for progression-free survival
Time Frame: up to 2 years
|
A secondary outcome is to observe for progression-free survival (PFS) and after the start of 1st cycle of treatment
|
up to 2 years
|
Observation for duration of response
Time Frame: Up to 2 years
|
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
|
Up to 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Breast Neoplasms
- Nasopharyngeal Carcinoma
- Triple Negative Breast Neoplasms
Other Study ID Numbers
- CTM-N2D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
-
Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
Epizyme, Inc.RecruitingAdvanced Soft-tissue Sarcoma | Advanced Epithelioid SarcomaUnited States, Taiwan, Canada, United Kingdom
-
Brown UniversityActuate Therapeutics Inc.WithdrawnSoft Tissue Sarcoma | Osteosarcoma | Ewing Sarcoma of Bone | Leiomyosarcoma | High Grade Sarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Bone Sarcoma | Synovial Sarcoma | Undifferentiated Pleomorphic Sarcoma | Myxofibrosarcoma | Spindle Cell SarcomaUnited States
-
David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
Clinical Trials on Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell
-
National Institute of Allergy and Infectious Diseases...University of Pennsylvania Clinical Cell and Vaccine Production Facility...Not yet recruitingKidney Failure | End Stage Renal Failure on Dialysis | Kidney TransplantUnited States
-
Northwestern UniversityNational Cancer Institute (NCI)RecruitingRecurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma | Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements | Recurrent... and other conditionsUnited States
-
Lazaros LekakisGenentech, Inc.RecruitingRefractory Non-Hodgkin Lymphoma | Relapsed Non Hodgkin Lymphoma | Aggressive Non-Hodgkin LymphomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingPlatinum-Resistant Ovarian CarcinomaUnited States
-
National Cancer Institute (NCI)CompletedMyeloma-Multiple | Myeloma, Plasma-CellUnited States
-
The First Affiliated Hospital of Soochow UniversityWest China Hospital; Affiliated Hospital of Jiangnan University; The Affiliated... and other collaboratorsRecruitingRelapsed/Refractory B-cell Non-Hodgkin's LymphomaChina
-
AbClonRecruitingB-cell Non Hodgkin LymphomaKorea, Republic of
-
Jonsson Comprehensive Cancer CenterParker Institute for Cancer ImmunotherapyRecruitingRecurrent Mantle Cell Lymphoma | Recurrent Small Lymphocytic Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Refractory Chronic Lymphocytic Leukemia | CD20 Positive | Refractory Mantle Cell Lymphoma | Recurrent Chronic Lymphocytic Leukemia | Refractory... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)WithdrawnProgressive Disease | Recurrent B Acute Lymphoblastic Leukemia | Refractory B Acute Lymphoblastic Leukemia | Refractory Chronic Lymphocytic Leukemia | Recurrent Non-Hodgkin Lymphoma | Refractory Non-Hodgkin Lymphoma | Minimal Residual Disease | Recurrent Chronic Lymphocytic Leukemia | CD19 Positive | CD22...United States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingChronic Graft Versus Host Disease | Hematologic and Lymphocytic Disorder | Steroid Refractory Graft Versus Host DiseaseUnited States