AzTrials
AzTrials

Gastric CancerPhase 1NCT05472857

Clinical Study of CLDN18.2-targeting CAR T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression

A Phase 1 study testing Claudin 18.2 CAR-T in people with Gastric Cancer and Pancreatic Cancer, run by Suzhou Immunofoco Biotechnology Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Claudin 18.2 CAR-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
8 Aug 2022to Dec 2024
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible for screening for potential inclusion in the study:
  • The age is between 18 and 70 years old (including the boundary value), both male and female.
  • Subjects with advanced CLDN 18.2 positive malignant solid tumors confirmed by histology or cytology in the past (including advanced gastric cancer or esophagogastric junction adenocarcinoma, advanced pancreatic cancer, and metastatic ovarian cancer without standard treatment).
  • All subjects are required to provide tumor tissue specimens that can be used for CLDN 18.2 analysis, which must be tumor histopathological specimens within 24 months before signing the informed consent, or fresh biopsy specimens collected within 6 months before cell reinfusion ; CLDN 18.2 histological staining of biopsy tumor tissue specimens is positive (defined as staining intensity ≥ 1+, positive rate ≥ 10%), the recommended antibody for detection is: Anti-Claudin18.2 antibody.
  • Estimated life expectancy≥12 weeks.
  • At least 1 measurable lesion per RECIST version1.1;
Show all 12Show fewer
  • ECOG performance status score of 0-1.
  • The subject has adequate organ and bone marrow function.
  • All toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level for inclusion/exclusion criteria.
  • Fertility status: Female patients of childbearing age or male patients whose sexual partners are females of childbearing age are willing to take medically approved high-efficiency contraceptive measures such as intrauterine devices from the time of signing the informed consent to 6 months after the last cell infusion or condoms (women of childbearing age include premenopausal women and women within 24 months of postmenopause).
  • Subjects must sign and date written informed consent.
  • Subjects must be voluntary and able to comply with predetermined treatment regimens, laboratory tests, follow-up and other research requirements.

Who cannot join

  • Subjects who meet any of the following conditions are not eligible for this study;
  • Pregnant and lactating women.
  • Known history of human immunodeficiency virus (HIV) infection; acute or chronic active hepatitis B (HBsAg positive or HBsAb positive, and HBV-DNA positive); acute or chronic active hepatitis C (HCV antibody positive) , and HCV-RNA was positive). Syphilis antibody positive; EB virus DNA quantification >500 copies (or according to the positive standard detected by each research center); cytomegalovirus (CMV) infection (IgM positive).
  • Serious infection in active stage or poorly controlled clinically.
  • There is currently a heart disease requiring treatment or hypertension that is poorly controlled by the investigator (defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure > 90 mmHg after standardized antihypertensive drug treatment).
  • Within 6 months before cell reinfusion, any of the following cardiac clinical symptoms or diseases: left ventricular ejection fraction (LVEF) < 50%; previous history of coronary heart disease, myocardial infarction, severe heart failure and severe arrhythmia.
Show all 24Show fewer
  • Evidence of major coagulation disorder or other significant bleeding risk: including but not limited to receiving conventional anticoagulation therapy (such as warfarin or heparin). Patients require long-term antiplatelet therapy (aspirin, dose >300mg/day; clopidogrel, dose >75mg/day); dipyridamole, ticlopidine or cilostazol, etc.
  • Subjects requiring systemic therapy with corticosteroids or other immunosuppressive drugs during the treatment period.
  • Blood oxygen saturation ≤95% before treatment (refers to pulse oxygen detection).
  • Diffuse lung metastases.
  • Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis, and symptomatic interstitial lung disease or active pneumonia found on chest CT scan within 4 weeks before the first study drug treatment.
  • Uncontrollable pleural effusion, pericardial effusion and ascites effusion existed before enrollment.
  • Poorly controlled diabetes (glycated hemoglobin HbA1c ≥ 8%).
  • Received systemic steroids equivalent to >15mg/day prednisone within 2 weeks before apheresis, except inhaled steroids.
  • The subject has developed new arrhythmias, including but not limited to uncontrolled arrhythmias, hypotension requiring vasopressors, bacterial, fungal or viral infections requiring intravenous antibiotics prior to preconditioning . Subjects using the trial antibiotic to prevent infection were at the discretion of the investigator to continue participating in the trial.
  • Known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system disease; central nervous system metastases or meningeal metastases with clinical symptoms, or other evidence of central nervous system metastases or Meningeal metastases have not yet been controlled, and were judged by the investigator to be unsuitable for enrollment.
  • Patients with previous or concomitant malignancies, with the following exceptions: Adequately treated basal cell or squamous cell carcinoma, cured cervical or breast carcinoma in situ, primary malignancy that has been completely resected and complete remission for ≥5 years.
  • Received other CAR-T therapy and TCR-T therapy in the past.
  • Received the following treatments or drugs before cell reinfusion: within 28 days before cell reinfusion, received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (treatments that met the requirements of the plan before reinfusion, such as bridging therapy) Except for), or any unmarketed experimental drug treatment; received traditional Chinese medicine treatment with anti-tumor indications within 2 weeks before cell reinfusion.
  • Subjects who have received other gene therapy in the past.
  • Subjects with severe mental disorders.
  • Participated in other clinical studies within the past 1 month.
  • The investigator assesses that the subject is unable or unwilling to comply with the requirements of the research protocol.
  • Subjects withdrew from the study for various reasons and could not participate in the study again.

Trial locations and contacts

1 site in 1 country.

Zhengmao Lu, MD contact

+86 21 50907211

luzhengmao82@126.com

Ai Guoqiang, MD contact

86-18482022722

guoqiang.ai@immunofoco.com

China1 site, 1 recruiting

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200000

    Zhengmao Lu, MD, +86 21 50907211, luzhengmao82@126.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of CLDN18.2-targeting Chimeric Antigen Receptor-modified Autologous T Cells in Advanced Solid Tumors With Positive CLDN18.2 Expression

This is an open label, multi-center, Phase 1 clinical trial to evaluate the safety and efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in advanced solid tumors with positive CLDN18.2 expression

Read the detailed description

Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product (IMC002). Following manufacture of the drug product, subjects will receive preconditioning prior to IMC002 infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.

Being tested
Claudin 18.2 CAR-T
Keywords
Claudin 18.2 CAR-T
Medical subject headings
Stomach Neoplasms, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Claudin 18.2 CAR-TBiological

    Also called IMC002

    treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion

Study groups in NCT05472857
Study groupRoleWhat they receive
anti-claudin18.2 chimeric antigen receptor T-cell therapyExperimentalanti-claudin18.2 chimeric antigen receptor T-cell therapy，infusion
Receives: Biological: Claudin 18.2 CAR-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment Related adverse events (AEs)

    Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)

    Measured: day1 - month12

  2. Identification of Maximum Tolerated Dose (MTD)

    Incidence of dose-limiting toxicities (DLTs)

    Measured: day1 - day28

Secondary outcomes (4)

  1. Objective Response Rate (ORR)，as assessed by Investigators

    The Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

    Measured: day1 - month12

  2. Duration of response (DOR)，as assessed by Investigators

    Duration of response (DOR) is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.

    Measured: day1 - month12

  3. Disease control rate (DCR), as assessed by Investigators

    Disease control rate (DCR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.

    Measured: day1 - month12

  4. Progression-free survival (PFS), as assessed by Investigators

    Progression-free survival (PFS) was defined as the time from the date of first infusion of CT041 to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.

    Measured: day1 - month12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start8 Aug 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Accelerated titration and Bayesian optimal interval design (BION) dose escalation design
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05472857
Sponsor's protocol ID
IMC002-CT01
Status last verified
Mar 2024
First submitted
20 Jul 2022
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Claudin 18.2 CAR-T in people with Gastric Cancer and Pancreatic Cancer, run by Suzhou Immunofoco Biotechnology Co., Ltd at 1 site in China.

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 12 inclusion and 24 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 6 Mar 2024. 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 China. 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 Zhengmao Lu, MD (+86 21 50907211, luzhengmao82@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment Related adverse events (AEs) (time frame: day1 - month12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05472857.

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 6 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in