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New treatment option for Gastric Adenocarcinoma
Official title A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients
ClinicalTrials.gov ID: NCT07103668
What this study is testing
What is CAR T cells?
CAR T cells is an investigational medicine, being studied as a potential treatment for gastric adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- An open-label, randomized, comparative phase II study including patients with CLDN18.2-positive unresectable locally advanced gastric cancer. To evaluate the objective response rate (ORR) and progression-free survival (PFS) of IMC002 compared with investigator's choice of treatment (ICT) as third-line or later therapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The age at randomization was at least 18 years old , and both men and women were eligible.
- histologically or cytologically confirmed inoperable locally advanced or metastatic gastric/esophagogastric junction adenocarcinoma who have failed...
- Radiographic progression or clinical worsening of symptoms during second-line treatment (if first-line treatment includes three drugs including...
- Patients with intolerance to second-line treatment may also be enrolled in the study after full evaluation by the investigator. The definition of...
- Tumor tissue specimens (primary or metastatic, archived or newly collected) from people are expected to be available and tested by a central...
You likely can't join if
- . This excludes other toxicities such as alopecia and vitiligo that the investigator believes do not pose a safety risk to the people.
- Reproductive status: Female patients of childbearing age or male patients whose sexual partners are female patients of childbearing age are willing...
- The people must sign and date the written informed consent form.
- people must be willing and able to comply with the scheduled treatment regimen, laboratory tests, follow-up and other study requirements. Exclusion...
- Pregnant and breastfeeding women.
- Positive human immunodeficiency virus (HIV) antibody test; hepatitis B virus infection ( HBsAg positive and/or HBc antibody positive, and HBV-DNA...
See the full eligibility criteria
Who can join
- The age at randomization was at least 18 years old , and both men and women were eligible.
- histologically or cytologically confirmed inoperable locally advanced or metastatic gastric/esophagogastric junction adenocarcinoma who have failed at least two prior lines of therapy :
- Radiographic progression or clinical worsening of symptoms during second-line treatment (if first-line treatment includes three drugs including taxanes (or anthracyclines), platinums, and fluorouracils, and the disease...
- Patients with intolerance to second-line treatment may also be enrolled in the study after full evaluation by the investigator. The definition of intolerance to previous treatment is as follows: any Grade ≥ 3 (according...
- Tumor tissue specimens (primary or metastatic, archived or newly collected) from people are expected to be available and tested by a central laboratory, indicating positive histological staining for CLDN18.2 (defined as...
- The subject's expected survival period is ≥12 weeks.
- According to RECIST 1.1, there should be at least one stably measurable target lesion or evaluable lesion, and the longest diameter of the largest lesion (or the shortest diameter if it is a lymph node lesion) should be...
- ECOG performance status score is 0-1.
- The subject must have adequate organ and bone marrow function. Laboratory screening must meet the following criteria. All laboratory test results should be within the stable ranges described below, and there should be...
- Blood tests [no enhanced blood transfusion ( ≥ 2 times within 1 week), platelet transfusion, or cell growth factor (except recombinant erythropoietin) within 7 days before the examination]: neutrophil count ≥ 1.5×10 9...
- Liver function: alanine aminotransferase (ALT) ≤ 2.5×ULN, aspartate aminotransferase (AST) ≤ 2.5×ULN, serum total bilirubin (TB) ≤ 2×ULN; for patients with liver metastasis, AST and ALT \< 5×ULN;
- Renal function: Serum creatinine ≤ 1.5 × ULN. If serum creatinine is \> 1.5 × ULN, creatinine clearance \> 50 mL/min (based on the Cockcroft-Gault formula); qualitative urine protein ≤ 1+; if qualitative urine protein...
- Amylase and lipase ≤ 1.5 × ULN; alkaline phosphatase (ALP) ≤ 2.5 × ULN. For patients with bone metastases, ALP \< 5 × ULN.
- All toxic reactions caused by previous anti-tumor therapy have been alleviated to Grade 0-1 (according to NCI CTCAE Version 5.0) or to a level acceptable to the inclusion/
What rules you out
- . This excludes other toxicities such as alopecia and vitiligo that the investigator believes do not pose a safety risk to the people.
- Reproductive status: Female patients of childbearing age or male patients whose sexual partners are female patients of childbearing age are willing to take medically approved and highly effective contraceptive measures...
- The people must sign and date the written informed consent form.
- people must be willing and able to comply with the scheduled treatment regimen, laboratory tests, follow-up and other study requirements. Exclusion Criteria:
- Pregnant and breastfeeding women.
- Positive human immunodeficiency virus (HIV) antibody test; hepatitis B virus infection ( HBsAg positive and/or HBc antibody positive, and HBV-DNA positive ); acute or chronic active hepatitis C (HCV antibody positive...
- Known HER2 expression is positive (defined as IHC 3+, or IHC 2+ and FISH+).
- Active or clinically poorly controlled serious infection.
- Patients had uncontrollable pleural effusion, pericardial effusion, and ascites before enrollment.
- Extensive or diffuse lung metastases or extensive or diffuse liver metastases or extensive or diffuse bone metastases .
- Blood oxygen saturation is ≤ 95% without oxygen inhalation.
- Other serious pulmonary diseases that may limit their participation in this study, such as pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly controlled interstitial lung disease, or...
- Patients with deep and large ulcers of the primary lesion, or recurrence of the anastomotic site with tumor infiltration of the entire layer, or tumor lesions infiltrating large blood vessels, who are judged by the...
- Patients with known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system diseases, such as epileptic seizures, cerebral ischemia/hemorrhage, dementia...
- unstable heart disease that requires treatment or heart disease that cannot be controlled after treatment, or hypertension that is poorly controlled as determined by the researchers (defined as systolic blood pressure ≥...
- Any of the following cardiac clinical symptoms or diseases within 6 months before cell infusion:
- Left ventricular ejection fraction (LVEF) \< 50%;
- Myocardial infarction within 1 year; or unstable angina; or history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); use of pacemaker;
- Resting electrocardiogram (ECG) with QTc F \>450 ms (male) or QTc F \>470 ms (female);
- Resting electrocardiogram reveals clinically significant abnormalities (such as abnormalities in heart rate, conduction, or morphological characteristics), complete left bundle branch block, third- degree...
- Evidence of a significant coagulopathy or other significant bleeding risk, including:
- clinically significant coagulation abnormalities;
- A history of intracranial hemorrhage or spinal cord hemorrhage;
- Patients whose tumor lesions invade large blood vessels and have a significant risk of bleeding;
- Patients with current unstable or active ulcers or active gastrointestinal bleeding;
- An embolic event occurred within 6 months before cell transfusion;
- Clinically significant hemoptysis or significant bleeding in tumor lesions occurred within 1 month before cell transfusion;
- Major trauma or major surgery within 1 month before enrollment;
- The presence of any bleeding disorders, such as hemophilia, von Willebrand disease, etc.;
- Use of anticoagulant therapy (except low molecular weight heparin) for therapeutic purposes within 2 weeks before cell transfusion;
- Patients are currently receiving conventional anticoagulant therapy (such as warfarin or heparin). Patients require long-term antiplatelet therapy (aspirin ≥ 100 mg/day; clopidogrel ≥ 75 mg/day); dipyridamole...
- Receipt of systemic steroids equivalent to \>15 mg/day of prednisone for more than 3 days within 2 weeks before apheresis, excluding inhaled steroids.
- people requiring systemic treatment with corticosteroids or other immunosuppressive drugs during treatment. people with any active autoimmune disease, or a history of autoimmune disease with expected recurrence...
- Patients with previous or concurrent malignancies, with the following exceptions:
- Adequately treated basal cell or squamous cell carcinoma of the skin (adequate wound healing was required before study enrollment);
- Carcinoma in situ of cervical or breast cancer who has undergone curative treatment and has no signs of recurrence for at least 3 years before the study;
- The primary malignancy has been completely resected and remains in complete remission for ≥ 5 years.
- people who have previously received other gene therapies, including but not limited to CAR-T therapy and TCR-T therapy .
- Received the following treatments or drugs before cell infusion: received chemotherapy, targeted therapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (except for treatments used...
- There is a history of other severe allergies such as anaphylactic shock.
- people with severe mental disorders.
- If a subject develops a new arrhythmia, including but not limited to arrhythmias that cannot be controlled with medication; hypotension requiring pressor medication; or bacterial, fungal, or viral infection requiring...
- Participation in other treatment clinical studies and use of study drug within 1 month before the planned IMC 002 infusion .
- The investigator assesses that the subject is unable or unwilling to comply with the requirements of the study protocol.
- 4 weeks before the planned apheresis time or plan to receive a live attenuated vaccine during the study.
- people with gastrointestinal obstruction or obstructive jaundice are deemed unsuitable for participation in this trial by the investigator .
- people with any other concurrent serious and/or uncontrolled medical conditions who are deemed unsuitable for participation in this trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.