Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Supercharged immune cells take on stubborn esophageal cancer

NCT ID NCT07622940

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new treatment for advanced esophageal cancer that has not responded to standard therapies. The treatment uses specially engineered immune cells (CAR-NK cells) from donated cord blood that are designed to recognize and attack cancer cells carrying two specific proteins (CLDN18.2 and HER2). Up to 36 adults will receive the cells along with chemotherapy to prepare the body. The main goals are to check safety and find the right dose, while also looking for signs that tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
engineered immune cells (CAR-NK cells) targeting CLDN18.2 and HER2 proteins, plus chemotherapy drugs fludarabine and cyclophosphamide
What this could lead to
If it works, this could point toward a new treatment option for advanced esophageal cancer that has stopped responding to standard therapies.
What could go wrong
This is an early phase 1/2 trial with only 36 participants, so results are preliminary. The treatment may not shrink tumors or could cause serious side effects like immune reactions or organ damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 ≥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. * 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. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Biomarker-selected CLDN18.2-positive and/or HER2-positive disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus esophageal adenocarcinoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518036, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.