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New treatment option for Pancreatic Cancer
Official title Mesothelin and Claudin 18.2 Dual-Target CAR-T Therapy in Advanced Pancreatic Cancer
ClinicalTrials.gov ID: NCT07066995
What this study is testing
What is Mesothelin and Claudin 18.2 CAR-T cells?
Mesothelin and Claudin 18.2 CAR-T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic cancer.
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
- Autologous T-cells engineered to express CARs targeting Mesothelin and Claudin18.2, for Unresectable locally advanced or metastatic pancreatic adenocarcinoma (Pancreatic Ductal Adenocarcinoma, PDAC), administered as two separate sequential infusions following lymphodepleting chemotherapy
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 90
You may be able to join if
- Expected survival time ≥3 months;
- Histologically or cytologically confirmed pancreatic adenocarcinoma that is advanced (unresectable or metastatic). Patients should have received, or...
- ECOG Performance Status: 0 or 1 (fully active or restricted in strenuous activity but ambulatory).
- Liver and kidney function, cardiopulmonary function meet the following requirements:
- Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
You likely can't join if
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer...
- Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to...
- Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug...
- Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days...
- Pregnant or lactating women, and female people who plan pregnancy within 2 years after cell transfusion or male people whose partners plan pregnancy...
- Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
See the full eligibility criteria
- Expected survival time ≥3 months;
- Histologically or cytologically confirmed pancreatic adenocarcinoma that is advanced (unresectable or metastatic). Patients should have received, or be intolerant of, standard first-line therapy (e.g...
- ECOG Performance Status: 0 or 1 (fully active or restricted in strenuous activity but ambulatory).
- Liver and kidney function, cardiopulmonary function meet the following requirements:
- Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
- Blood oxygen saturation \>91% in non-oxygen state;
- Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the...
- No serious mental disorders;
- Can understand this test and has signed the informed consent.
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus...
- Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe...
- Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
- Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;
- Pregnant or lactating women, and female people who plan pregnancy within 2 years after cell transfusion or male people whose partners plan pregnancy within 2 years after cell transfusion;
- Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
- Participated in other clinical studies 1 month before screening;
- Evidence of central nervous system invasion during subject screening;
- Mental patients with depression or suicidal thoughts;
- Situations considered unsuitable for inclusion by other researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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, 21 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, 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.