ClinicalTrials.gg
RecruitingNCT06453057Updated Apr 14, 2026

Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours

An interventional study of GT307 injection in Adult, sponsored by Grit Biotechnology. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Grit Biotechnology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 4 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).

02

Conditions studied

  • Adult
03

In context

Lead sponsor

Grit Biotechnology is the lead sponsor of 30 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. Voluntarily join the study, signed form, willing and able to comply with the study protocol;
  • 2. Age 18 to 70 years old;
  • 3. Ovarian cancer that progresses after recurrence or chemotherapy;
  • 4. (ECOG) performance status score of 0 or 1;
  • 5. Expected survival time of ≥ 12 weeks;
  • 6. Good function of vital organs;
  • 7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
  • 8. At least one measurable target lesion that meets the definition of v1.1 after tumor sampling.

Exclusion criteria

Exclusion Criteria:

  • 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
  • 2.Known mental illness, alcoholism, drug use or substance abuse;
  • 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
  • 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
  • 5.The investigators determine that other conditions that make the patient not suitable for enrollment.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (estimated)

Study arms

  • Experimental
    GT307 injection treatment group

    Biological: GT307 injection

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adcersed events per CTCAE 5.0

    To characterize the safety profile of autologous TIL injection(GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0

    Time frame: 3 years

  2. Objective response rate

    To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Jun 2027, 35 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 7, 2024
First posted
Jun 11, 2024
StartActual
Jul 4, 2024
Primary completionEst.
Jun 6, 2027
CompletionEst.
Jun 6, 2027
Last update
Apr 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06453057
Lead sponsor
Grit Biotechnology
Responsible party
Sponsor
First posted
Jun 11, 2024
Start date
Jul 4, 2024
Primary completion
Jun 6, 2027 (estimated)
Completion
Jun 6, 2027 (estimated)
Last update
Apr 14, 2026

Study contacts

Kang Yu, PHD
Contact
kangyu1489@fckyy.org.cn
+86 (021)63455050 ext. 8571

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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