What is CTM-N2D studying for advanced cancers?

CTM-N2D is being studied as a new type of immune cell therapy for advanced solid tumors and blood cancers. Researchers want to find the best dose and understand its safety and effects on tumors. This trial is sponsored by CytoMed Therapeutics to explore a treatment that may work where others have limitations.

Who may be eligible for this cancer clinical trial?

Adults aged 21 or older with metastatic cancer resistant to at least two standard treatments may be eligible. Participants should have good overall health, measurable tumors, and meet specific blood and organ function requirements. Both males and females can join, with certain contraception rules for reproductive-age women and men. Please review eligibility criteria for more details.

Is there any cost to participate in this cancer clinical trial?

Study-related care, including the study treatment and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be reimbursed. Participants should plan accordingly for any costs related to getting to and from study visits.

Actively Recruiting

Phase 1

Age: 21Years +

All Genders

ID05302037

Phase I Study of Allogeneic NKG2DL-targeting CAR gamma delta T Cells CTM-N2D for Advanced Solid Tumors and Blood Cancers

Led by CytoMed Therapeutics Pte Ltd · Updated on 2024-11-22

Participants Needed

Research Sites

56 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating a new cancer treatment called CTM-N2D, which uses engineered immune cells called allogeneic NKG2DL-targeting CAR-gamma delta T cells. This phase I trial aims to find the best dose and evaluate the safety and tolerability of CTM-N2D in patients with advanced solid tumors or blood cancers. The study is sponsored by CytoMed Therapeutics and includes safety monitoring by an independent board. CTM-N2D treatment involves giving patients infusions of these modified immune cells derived from healthy donors. The study has two parts a dose-escalation phase where patients receive four weekly infusions at increasing doses, and an optimal dose phase where patients receive four infusions at the determined best dose once per week. If patients do not show disease progression after initial treatment and imaging at two months, they may receive maintenance doses every two months for up to five doses, with regular scans to assess disease status. Participants will undergo lymphodepletion with chemotherapy before the first CTM-N2D infusions, and receive additional supportive treatments to enhance cell survival. Throughout the study, blood samples and imaging will be collected to monitor safety, cell activity, and tumor response using standardized criteria. Patients will be followed for adverse events, tumor outcomes, and survival for up to 48 months after treatment. Safety and adverse effects will be closely tracked with the option to discontinue treatment if necessary.

CONDITIONS

Brief Title

Allogeneic NKG2DL-targeting CAR γδ T Cells (CTM-N2D) in Advanced Cancers (ANGELICA)

Who Can Participate

Age: 21Years +

All Genders

Eligibility Criteria

You may qualify if you...

At least 21 years of age
Signed written informed consent before any study procedures
ECOG performance status of 0 or 1 and life expectancy greater than 12 weeks
Females of reproductive age must use effective contraception if sexually active, not breast feeding, and have a negative pregnancy test before lymphodepletion
Sexually active males must use barrier contraception during the study and for 6 months after last dose if partner is of child-bearing potential
Adequate liver, kidney, lung, and bone marrow function as defined by laboratory values
Metastatic cancer resistant to or unsuitable for at least two standard cancer therapies
Presence of measurable tumor by RECIST 1.1 criteria
Serum vitamin D level of at least 20 ng/ml
Diagnosis of cancer known to express NKG2D ligands

You will not qualify if you...

Any unresolved toxicities from prior therapy greater than or equal to Grade 2 except alopecia
Spinal cord compression or brain metastases unless stable, asymptomatic, and off steroids for at least 4 weeks
Severe or uncontrolled systemic diseases, active bleeding disorders, renal transplant, or active infections including HIV or hepatitis
Positive hepatitis B surface antigen; further testing for certain hepatitis B antibody cases
Active or prior autoimmune or inflammatory disorders except specific stable or controlled conditions
Severe uncontrolled medical or psychiatric conditions
Female patients who are breast-feeding or not using effective contraception
Use of investigational products or biological agents within 4 weeks before lymphodepletion
Major surgery within 4 weeks before lymphodepletion
Radiation therapy within 3 weeks before lymphodepletion except palliative bone radiation
Active infection requiring long-term systemic treatment
Cardiac dysfunction including recent myocardial infarction, heart failure, unstable angina or arrhythmias, and abnormal ECG findings
Failed dental clearance for zoledronic acid administration
Likely inability to comply with study procedures or restrictions

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 4 weeks

Participants receive lymphodepletion followed by up to four weekly infusions of CTM-N2D. A dose of zoledronic acid is given one day before each infusion, and IL-2 is injected within 2 hours after each infusion to enhance treatment potency.

4 weekly visits for CTM-N2D infusion

Treatment

Duration - Up to 10 months

Participants who do not show disease progression after the first 4 doses and imaging at 2 months may receive up to 5 maintenance doses of CTM-N2D, administered once every 2 months. Imaging is performed every 2 months to evaluate disease status before each maintenance dose.

Up to 5 visits every 2 months for maintenance infusion and imaging assessments

Follow-up

Duration - Up to 48 months

Participants are followed for safety and survival status after completion or discontinuation of treatment. Follow-up includes monitoring for adverse events and survival up to 48 months after the last patient starts treatment.

Periodic visits as determined by the investigator