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Off-the-Shelf cell therapy takes on Hard-to-Treat cancers

NCT ID NCT07589530

Disease control Sponsor: Beijing Biotech Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new treatment called EB-NK-301, which uses specially engineered immune cells (CAR NK cells) to target a protein called TROP2 found on many solid tumors. The trial enrolls 60 adults with advanced or metastatic cancers that have not responded to standard treatments. Participants first receive chemotherapy to prepare their bodies, then the EB-NK-301 cells are infused. The main goals are to check safety and find the best dose.

What this could mean

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

Active substance
EB-NK-301 (a type of immune cell called a CAR NK cell that targets TROP2 on cancer cells)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with only 60 participants, so results may not apply to everyone. The treatment may cause side effects or fail to shrink tumors.

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 60 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: * Age 18 to 75 years at the time of informed consent. * Histologically or cytologically confirmed advanced or metastatic solid tumor with documented TROP2 expression (per local testing or central confirmation). * Disease progression on, intolerance to, or ineligibility for available standard therapy. * At least one measurable lesion per RECIST 1.1. * ECOG performance status 0 to 1. * Adequate organ function (hematologic, renal, hepatic) within protocol-defined limits. * Life expectancy ≥ 12 weeks. * Willingness to use effective contraception during study participation and for a protocol-defined period after last infusion (if of childbearing potential). * Ability to understand and willingness to sign written informed consent. Exclusion Criteria: * Active central nervous system (CNS) metastases or leptomeningeal disease (unless treated and clinically stable for ≥ 4 weeks). * Prior allogeneic hematopoietic stem cell transplant or solid organ transplant. * Uncontrolled active infection, including uncontrolled hepatitis B, hepatitis C, or HIV infection. * Active autoimmune disease requiring systemic immunosuppression. * Clinically significant cardiovascular disease (e.g., recent myocardial infarction or stroke within 6 months, uncontrolled arrhythmia). * Receipt of another investigational agent within 2 weeks (or 5 half-lives, whichever is longer) prior to lymphodepleting chemotherapy. * Prior gene-modified cellular therapy within 3 months prior to enrollment. * Systemic corticosteroid therapy \> 10 mg/day prednisone equivalent within 7 days prior to lymphodepletion (excluding physiologic replacement). * Pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm

As listed by the trial registrant

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

Advanced solid tumors Metastatic solid tumors TROP2-expressing solid tumors

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

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