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Engineered immune cells take aim at hard-to-treat blood cancers

NCT ID NCT06699771

Cure Sponsor: GC Cell Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This early-phase trial is testing an experimental therapy called GCC2005, which uses a patient's own immune cells (natural killer cells) engineered to recognize and attack cancer cells. The study enrolls adults with NK or T-cell cancers that have returned or not responded to at least two prior treatments. Participants receive GCC2005 along with chemotherapy to prepare the body, and researchers monitor safety, side effects, and any signs of tumor shrinkage.

What this could mean

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

Active substance
an experimental CAR-NK cell therapy called GCC2005, given with lymphodepleting chemotherapy
What this could lead to
If successful, this could point toward a new treatment option for people with hard-to-treat NK and T-cell cancers.
What could go wrong
This is an early, first-in-human phase 1 trial with a small number of participants. Safety and effectiveness are not yet known, and there may be serious side effects.
Why investors are watching

GC Cell Corporation is running a Phase 1 trial of GCC2005, a first-in-human cell therapy, for patients with relapsed or refractory NK and T-cell malignancies who have already tried at least two prior treatments. For a small publicly traded company, this early-stage readout on safety and preliminary efficacy in a hard-to-treat cancer population is a major test of its pipeline. The outcome will show whether the company has a viable product candidate worth advancing.

If it works: A positive safety and efficacy signal could validate GCC2005 as a promising therapy and support further clinical development. That would strengthen the company's pipeline and its position in the cell therapy field.

If it fails: Phase 1 trials often fail to show enough safety or benefit, and this one is early and small. A poor result or delay could set back the program and hurt the company's prospects, since it has few other public assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 53 people

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

Started

Mar 2025

Expected to finish

Aug 2027

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

19 to 80 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: * Participants with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017). * Participants with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator. * According to the Lugano classification, Participants having lesion/nodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown. * Participant has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status. * Participants who satisfy the criteria defined in the protocol. * Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Participants who comply with all procedures of this study and voluntarily give written consent Exclusion Criteria: * Has T-ALL/T-LBL, CTCL or ALCL. * Participants with CNS lymphoma or any involvement of the CNS. * Participants who had a prior history of another malignancy over the last 3 years. * Participants who have used hematopoietic growth factor therapy within 14 days prior to Screening. * Participants who have had prior CAR-T or CAR-NK therapies. * Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management * Participants with previous allogenic organ transplantation * Participants with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency. * Participants with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion. * Participants with known active Hepatitis B or C * Participants with presence of Grade 2 or greater toxicity from the previous treatment.

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Conditions

The condition(s) this trial relates to.

T-cell non-Hodgkin lymphoma

As listed by the trial registrant

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

Lymphoma, T-cell

How to take part

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

  1. The places running it

    3 sites. 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

  • Asan Medical Center

    RECRUITING

    Seoul, Seoul, 05505, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, Seoul, 06351, South Korea

  • Seoul National University Hosptial

    RECRUITING

    Seoul, Seoul, 03080, South Korea

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