NCT05837299

Brief Summary

An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

April 6, 2023

Last Update Submit

April 19, 2023

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

  • DLT

    To observe the incidence of dose-limiting toxicity (DLT) after IMC008 infusion

    within 28 days

Secondary Outcomes (6)

  • TRAE

    up to 96 weeks

  • PFS

    upto 96 weeks

  • Objective response rate (ORR)

    upto 96 weeks

  • Tmax

    upto 96 weeks

  • Lymphocyte subsets

    upto 96 weeks

  • +1 more secondary outcomes

Study Arms (1)

IMC008 dose 1-3

EXPERIMENTAL

a certain number of IMC008 cell per kg will be infused

Drug: IMC008

Interventions

IMC008DRUG

allowing 10% dose error

Also known as: NKG2D receptor-modified autologous CAR -T cells targeting CLDN18.2
IMC008 dose 1-3

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced gastric cancer /esophagogastric junction adenocarcinoma advanced pancreatic cancer.
  • Tumor tissue samples of subjects expected to be available with positive for CLDN18.2 immunohistochemistry.
  • The expected survival period of the subject is ≥12 weeks.
  • The subject needs to have at least one target lesion that can be stably evaluated.
  • The ECOG score is 0-1.
  • Subject has adequate organ and bone marrow function
  • All toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-1.
  • Fertility status : Women of childbearing age or men whose sexual partners are women of childbearing age are willing to take medically approved high-efficiency contraceptive measures.
  • Subjects must sign and date written informed consent.

You may not qualify if:

  • Pregnant and lactating women.
  • Known history of human immunodeficiency virus infection; acute or chronic active hepatitis B; acute or chronic active hepatitis C. Syphilis antibody positive; Epstein-Barr virus infection; CMV infection.
  • Serious infection that is active or poorly controlled clinically.
  • Uncontrollable pleural effusion, pericardial effusion, peritoneal effusion existed before enrollment.
  • Extensive or diffuse lung metastases or extensive or diffuse liver metastases.
  • Oxygen saturation ≤ 95% without oxygen inhalation.
  • Suffering from other research diseases that may limit their participation in this study.
  • Known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system disease.
  • There are heart diseases that need to be treated or hypertension that is poorly controlled by the investigator, poorly controlled after standard treatment type 2 diabetes mellitus.
  • Presence of any cardiac clinical symptoms or disorders.
  • Evidence of significant coagulopathy or other significant bleeding risk.
  • Received systemic steroids equivalent to \>15 mg/ day prednisone cumulatively for more than 3 days within 2 weeks prior to apheresis , excluding inhaled steroids.
  • Prior or concurrent occurrence of other malignancies, with the following exceptions.
  • Subjects who have previously received other gene therapy.
  • Allergic/ intolerance to lymphodepletion regimen or CRS treatment drugs or IMC008.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Study Officials

  • Tianhang Luo, MD

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianhang Luo, MD

CONTACT

8613816977973luotianhang78@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose escalation of 3 dosage groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 1, 2023

Study Start

April 2, 2023

Primary Completion

December 31, 2025

Study Completion

March 31, 2026

Last Updated

May 1, 2023

Record last verified: 2023-04

Locations

CN(1)