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Dual-Target CLDN18.2/HER2 CAR-NK Cells for Advanced Esophageal Adenocarcinoma

RecruitingPhase 1, Phase 2Ages 18 Years - 75 YearsAllBeijing Biotech
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Histologically confirmed esophageal adenocarcinoma or Siewert I/II gastroesophageal junction adenocarcinoma judged biologically consistent with esophageal adenocarcinoma, unresectable/recurrent/metastatic, and not amenable to curative therapy. * 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 inappropriate/unavailable where standard in the local setting. * 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 โ‰ฅ75% of tumor cells with moderate/strong intensity or protocol-specified central threshold), and/or HER2-positive by IHC 3+ or IHC 2+/ISH-amplified disease. * ECOG performance status 0-1. * Adequate marrow, renal, hepatic, pulmonary, and cardiac function per protocol laboratory thresholds. * Life expectancy โ‰ฅ12 weeks. * Resolution of clinically significant prior-therapy toxicities to grade โ‰ค1 (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. Exclusion Criteria: * 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 efficacy. * 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.
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What it tests

  • EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells
  • Fludarabine
  • Cyclophosphamide
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Where

1 site
Peking University Shenzhen Hospital
Shenzhen, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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