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Can a cell therapy shrink Hard-to-Treat lung tumors?

NCT ID NCT05207371

Disease control Sponsor: GAIA BioMedicine Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental cell therapy called GAIA-102 in people with advanced or relapsed non-small cell lung cancer. Researchers give GAIA-102 alone or with the immunotherapy drug pembrolizumab to see if the combination is safe and can shrink tumors. The study first checks safety and dosing, then looks at how well the treatment controls the cancer.

What this could mean

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

Active substance
GAIA-102, an experimental cell therapy, given alone or with pembrolizumab (KEYTRUDA)
What this could lead to
If it works, this could offer a new treatment option for people with advanced or relapsed non-small cell lung cancer, potentially slowing the disease or shrinking tumors.
What could go wrong
This is an early-phase trial with only 22 participants, so the treatment may not prove effective or safe in a larger group. Cell therapies can also cause serious side effects, including immune reactions.

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

22 people

The number who actually took part.

Started

Dec 2021

Finished

Mar 2026

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

20 years and older

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: 1. Patients who have been confirmed to have NSCLC by histological or cytological examination 2. Patients with ECOG performance status (PS) 0-1 at the time of obtaining consent 3. Patients aged 20 years or older at the time of obtaining consent Exclusion Criteria: 1. Patients with symptomatological cranial nerve system metastasis. If treatment for cranial nerve system metastasis has already been performed and the neurologically recovered state has been maintained for 2 weeks or more before registration, registration is possible. 2. Patients diagnosed with cancerous meningitis 3. Patients who received allogeneic hematopoietic stem cell transplantation 4. Patients with active autoimmune disease

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

Cell therapy NSCLC

Contacts and locations

Locations

  • Kitakyushu Municipal Medical Center

    Kitakyushu, Fukuoka, 802-8561, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

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