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New treatment option for Recurrent or Metastatic Esophageal Adenocarcinoma
Official title Dual-Target CLDN18.2/HER2 CAR-NK Cells for Advanced Esophageal Adenocarcinoma
ClinicalTrials.gov ID: NCT07622940
What this study is testing
What is EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells?
EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent or metastatic esophageal adenocarcinoma.
Also referred to as Dual-target CAR-NK; EBNK-1822H2.
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
- This example study evaluates the safety, feasibility, cellular kinetics, and preliminary anti-tumor activity of EBNK-1822H2, an illustrative allogeneic cord blood-derived dual-target CAR-NK cell product directed against CLDN18.2 and HER2, in adults with relapsed/refractory or metastatic esophageal adenocarcinoma after standard therapy. The study uses dose escalation followed by biomarker-defined expansion and prospectively records EGFR expression as an exploratory biomarker of antigen escape.
- 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 18 to 75
You may be able to join if
- Histologically confirmed esophageal adenocarcinoma or Siewert I/II gastroesophageal junction adenocarcinoma judged biologically consistent with...
- Disease progressed after at least 1 prior systemic regimen for advanced disease, or the participant is intolerant of / ineligible for standard...
- At least 1 measurable lesion by RECIST v1.1.
- Evidence of at least one selected target: CLDN18.2-positive by validated IHC (example threshold: membranous staining in ≥75% of tumor cells with...
- ECOG performance status 0-1.
You likely can't join if
- Esophageal squamous cell carcinoma or non-adenocarcinoma histology.
- Known active CNS metastases or leptomeningeal disease; previously treated stable CNS disease may be allowed only if asymptomatic and off escalating...
- Prior gene-modified cellular therapy within 12 weeks, or another investigational therapy likely to confound interpretation of safety or how well it...
- Active uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV viremia, sepsis, or clinically significant opportunistic...
- Ongoing systemic immunosuppressive therapy above physiologic steroid replacement.
- Active autoimmune disease requiring systemic treatment within 2 years.
See the full eligibility criteria
- Histologically confirmed esophageal adenocarcinoma or Siewert I/II gastroesophageal junction adenocarcinoma judged biologically consistent with esophageal adenocarcinoma, unresectable/recurrent/metastatic, and not...
- Disease progressed after at least 1 prior systemic regimen for advanced disease, or the participant is intolerant of / ineligible for standard therapy. Biomarker-directed therapy must have been received or deemed...
- At least 1 measurable lesion by RECIST v1.1.
- Evidence of at least one selected target: CLDN18.2-positive by validated IHC (example threshold: membranous staining in ≥75% of tumor cells with moderate/strong intensity or protocol-specified central threshold), and/or...
- ECOG performance status 0-1.
- Adequate marrow, renal, hepatic, pulmonary, and cardiac function per protocol laboratory thresholds.
- Life expectancy ≥12 weeks.
- Resolution of clinically significant prior-therapy toxicities to grade ≤1 (except alopecia or stable endocrinopathies).
- Willingness to provide archival tumor tissue and to undergo fresh biopsy when safely feasible.
- Negative pregnancy test for participants of childbearing potential and agreement to protocol-defined contraception.
- Esophageal squamous cell carcinoma or non-adenocarcinoma histology.
- Known active CNS metastases or leptomeningeal disease; previously treated stable CNS disease may be allowed only if asymptomatic and off escalating steroids per protocol.
- Prior gene-modified cellular therapy within 12 weeks, or another investigational therapy likely to confound interpretation of safety or how well it works.
- Active uncontrolled infection, including uncontrolled hepatitis B, hepatitis C, HIV viremia, sepsis, or clinically significant opportunistic infection.
- Ongoing systemic immunosuppressive therapy above physiologic steroid replacement.
- Active autoimmune disease requiring systemic treatment within 2 years.
- Clinically significant interstitial lung disease/pneumonitis, uncontrolled cardiovascular disease, or left ventricular ejection fraction \<50%.
- Active gastrointestinal perforation, uncontrolled bleeding, or clinically significant mucosal ulceration that would increase study-treatment risk.
- Prior solid organ transplant or active graft-versus-host disease.
- Pregnant or breastfeeding.
- Another active malignancy requiring systemic therapy, except protocol-permitted low-risk cancers.
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, 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.