Actively Recruiting

Phase 1
Age: 21Years +
All Genders
ID05302037

A Phase I Trial to Evaluate Allogeneic NKG2DL-targeting CAR-gamma delta T Cells (CTM-N2D) in Advanced Solid Tumors or Hematological Malignancies

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

12

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

Sponsors

C

CytoMed Therapeutics Pte Ltd

Lead Sponsor

N

National University Hospital, Singapore

Collaborating Sponsor

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

Eligible

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
Not Eligible

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

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

National University Hospital

Singapore, Singapore

Actively Recruiting

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Research Team

A

Anand D Jeyasekharan, Dr

J

Jieming Zeng, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A phase I study of adoptive immunotherapy for recurrent non-small-cell lung cancer patients with autologous gammadelta T cells.

Jun Nakajima, Tomohiro Murakawa, Takeshi Fukami...

https://pubmed.ncbi.nlm.nih.gov/20137969

Intraperitoneal injection of in vitro expanded Vγ9Vδ2 T cells together with zoledronate for the treatment of malignant ascites due to gastric cancer.

Ikuo Wada, Hirokazu Matsushita, Shuichi Noji...

https://pubmed.ncbi.nlm.nih.gov/24515916