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Experimental immune cell therapy targets Hard-to-Treat cancers

NCT ID NCT05430360

Disease control Sponsor: Grit Biotechnology 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested a personalized treatment called GT201 for people with advanced solid tumors that had spread or returned. The therapy uses a patient's own immune cells (tumor-infiltrating lymphocytes) that are collected from a tumor, multiplied in a lab, and then infused back after a short course of chemotherapy. The study aimed to check safety and whether the treatment could shrink tumors, but it was stopped early after enrolling only 2 participants.

What this could mean

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

Active substance
GT201 (autologous tumor-infiltrating lymphocyte injection)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced solid tumors that have come back or spread.
What could go wrong
This is a very early, small trial (only 2 participants enrolled) that was terminated, so results are limited. The therapy involves strong chemotherapy and may cause serious side effects.

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

2 people

The number who actually took part.

Started

Jan 2022

Finished

Dec 2025

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 70 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: 1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol 2. At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes 3. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1. Exclusion Criteria: 1. Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment 2. People with uncontrolled tumor-related pain as judged by the investigator 3. Risk of major bleeding as assessed by investigators 4. Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function 5. Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy 6:History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7：Women who are pregnant or breastfeeding; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Solid tumor

Contacts and locations

Locations

  • The First Hospital of Zhejiang University

    Hangzhou, Zhejiang, China

More trials for these conditions

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