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RecruitingNCT05724732Updated Feb 13, 2023

Exploratory Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Gynecologic Tumors

An Early Phase 1 interventional study of GT201 in Solid Tumor, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-13.

Sponsored by RenJi Hospital · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 8 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
Female
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Study summary

This study is a single-center, single-arm phase I clinical trial. A total of 24\~26 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period

02

Conditions studied

  • Solid Tumor
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In context

Genital Neoplasms, Female

117 studies on the registry are indexed under Genital Neoplasms, Female; 19 are open to participants now.

This study's planned enrollment of 24 is below the median of 90 across 92 interventional studies indexed under Genital Neoplasms, Female.

Browse Genital Neoplasms, Female studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

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

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Who can participate

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

Inclusion criteria

  • 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

    2.Patients with advanced cervical cancer, ovarian cancer, endometrial cancer and other gynecological tumors who have progressed or are intolerant to at least first-line therapy, or who are not suitable for existing first-line therapy.

    3.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.

    4.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

Exclusion criteria

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;

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    GT201 treatment group

    Autologous tumor infiltrating lymphocyte injection

    Biological: GT201

Interventions

  • BiologicalGT201

    Autologous tumor infiltrating lymphocyte injection

06

What researchers measure

Primary outcomes

  1. Safety Profile Measured by Grade ≥3 TEAEs

    To characterize the safety profile of autologous TIL injection(GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs)

    Time frame: 3 years

Secondary outcomes

  1. 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

  2. Progression-free survival

    To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator

    Time frame: 3 years

  3. Overall survival

    To evaluate efficacy parameters such Overall Survival (OS)

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 200127, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05724732
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Feb 13, 2023
Start date
Feb 1, 2023
Primary completion
May 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Feb 13, 2023

Study contacts

Wen Di, PhD
Contact
diwen163@163.com
+86 13701642665

Oversight

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

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