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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 3 months later.
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; 18 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

Inclusion criteria

  • 1. Voluntarily join the study, signed informed consent 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 first-line chemotherapy;
  • 4. Eastern Cooperative Oncology Group (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 RECIST 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.
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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

  • BiologicalGT307 injection

    GT307 injection to treat solid tumours

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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
  • Obstetrics & Gynecology Hospital of Fudan University
    Shanghai, Shanghai Municipality 200011, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
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 ↗
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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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