AzTrials
AzTrials

Recurrent or Metastatic Esophageal AdenocarcinomaPhase 1/2NCT07622940

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

A Phase 1/2 study testing EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells, Fludarabine and Cyclophosphamide in people with Recurrent or Metastatic Esophageal Adenocarcinoma and Biomarker-selected CLDN18.2-positive and/or HER2-positive Disease, run by Beijing Biotech at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
2 Mar 2026to 17 Mar 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • ≥75% 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

shan S Lu, Phd contact

+86 13076790030

Seni-Lu@beijing-biotech.com

China1 site, 1 recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

    Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com

    Recruiting

Other trials in China

About this study

Official title: A Phase 1/2, Open-Label, Biomarker-Selected Study of Allogeneic Dual-Target CLDN18.2/HER2 Chimeric Antigen Receptor Natural Killer Cells (EBNK-1822H2) in Adults With Relapsed, Refractory, or Metastatic Esophageal Adenocarcinoma

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.

Read the detailed description

Background and target-selection logic. Esophageal adenocarcinoma shares biomarker biology with GEJ adenocarcinoma. In the current public development landscape, CLDN18.2 and HER2 are the two most clinically actionable candidates for a first esophageal adenocarcinoma dual-target CAR-NK concept.

This example therefore advances a CLDN18.2/HER2 tandem-target product and treats EGFR as a pre-specified exploratory biomarker, not as the primary CAR target in version 1.

Investigational product. EBNK-1822H2 is a hypothetical off-the-shelf NK-cell product derived from cord blood and engineered with a tandem CAR recognizing CLDN18.2 and HER2, together with a persistence-support module (for example, membrane-bound IL-15) and an inducible caspase-9 safety switch. This is an example investigational product description for protocol-drafting purposes only.

Study structure. Phase 1 uses an open-label dose-escalation design after fludarabine/cyclophosphamide lymphodepletion to identify the maximum tolerated dose (MTD) and recommended phase 2 dose/schedule (RP2D/RP2S). Phase 2 expands at the selected regimen in three biomarker-defined strata: (1) CLDN18.2-positive/HER2-negative, (2) HER2-positive/CLDN18.2-low or negative, and (3) dual-positive disease. Participants receive one intravenous infusion on Day 0; a protocol-defined repeat infusion on Day 21 may be allowed in the expansion portion if there is no DLT or uncontrolled grade 3+ immune toxicity.

Correlative program. Screening includes central or local assessment of CLDN18.2 and HER2, with EGFR captured prospectively at baseline and, when feasible, at progression. Correlative studies include ctDNA response, cytokine profiling, CAR-NK persistence, tumor microenvironment markers, and antigen-pattern analyses to inform future multi-target program evolution.

Being tested
EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells, Fludarabine, Cyclophosphamide
Keywords
CAR-NK, Allogeneic NK cells, Cellular immunotherapy, CLDN18.2, HER2 (ERBB2), EGFR (exploratory biomarker), Esophageal adenocarcinoma, Gastroesophageal junction adenocarcinoma, Dose escalation, Dose expansion
Medical subject headings
Recurrence, Adenocarcinoma Of Esophagus

What participants receive

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

  • EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cellsBiological

    Also called Dual-target CAR-NK; EBNK-1822H2

    Illustrative allogeneic cord blood-derived NK-cell product engineered to recognize CLDN18.2 and HER2.

  • FludarabineDrug

    Also called Fludara

    Lymphodepletion backbone

  • CyclophosphamideDrug

    Also called Cytoxan

    Lymphodepletion backbone

Study groups in NCT07622940
Study groupRoleWhat they receive
EBNK-1822H2 after lymphodepletionExperimentalParticipants receive fludarabine and cyclophosphamide lymphodepletion followed by intravenous infusion of allogeneic dual-target CLDN18.2/HER2 CAR-NK cells on Day 0. A protocol-defined repeat infusion on Day 21 may be permitted in dose expansion if safety criteria are met.
Receives: Biological: EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

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

  1. Incidence of dose-limiting toxicities (DLTs)

    Measured: 28 days

  2. Incidence and severity of treatment-emergent adverse events

    Measured: 12 months

  3. Recommended phase 2 dose

    Measured: 6 months

Secondary outcomes (3)

  1. Objective response rate (ORR) by RECIST v1.1

    Measured: 12 months

  2. Disease control rate (DCR) by RECIST v1.1

    Measured: 12 months

  3. Duration of response

    Measured: 12 Months

Timeline

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

  1. First posted3 Jun 2026
  2. Study start2 Mar 2026
  3. Primary completion14 Mar 2027 (estimated)
  4. Study completion17 Mar 2028 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, multicenter, biomarker-selected, single-arm study. Phase 1 uses dose escalation of EBNK-1822H2 after fludarabine/cyclophosphamide lymphodepletion to identify the MTD and/or RP2D/RP2S. Phase 2 expands the selected regimen in biomarker-defined cohorts (CLDN18.2-positive, HER2-positive, or dual-positive). EGFR status is collected prospectively for exploratory analyses but does not determine armassignment.
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07622940
Sponsor's protocol ID
EBNK-EAC-1822H2-116
Status last verified
May 2026
First submitted
25 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EBNK-1822H2 dual-target CLDN18.2/HER2 CAR-NK cells, Fludarabine and Cyclophosphamide in people with Recurrent or Metastatic Esophageal Adenocarcinoma and Biomarker-selected CLDN18.2-positive and/or HER2-positive Disease, run by Beijing Biotech 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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 3 Jun 2026. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact shan S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) (time frame: 28 days). The study lists 3 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 NCT07622940.

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 3 Jun 2026.

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