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Metastatic or Recurrent Gynecological TumorsPhase 1NCT05238818

Single Arm Phase I Trail of Autologous Tumor Infiltrating Lymphocyte Injection (GT202) in the Treatment of Metastatic or Recurrent Gynecological Tumors

A Phase 1 study testing Autologous Tumor Infiltrating Lymphocyte Injection (GT202) in people with Metastatic or Recurrent Gynecological Tumors, run by XinWu at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A prospective, open-label, non-randomized, Phase 1 study evaluating autologous tumor infiltrating lymphocyte injection (GT202) in the treatment of metastatic or recurrent Gynecological tumors. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Autologous Tumor Infiltrating Lymphocyte Injection (GT202)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
Mar 2022to Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Voluntary participation and sign informed consent
  • 2.Must be ≥ 18 and ≤70 years at the time of consent
  • 3.Must be diagnosis of unresectable Metastatic or Recurrent Gynecological Tumors (limited to cervical cancer, ovarian cancer and endometrial cancer)
  • 4.Must have progressed following at least one line of standard treatment, and there is no alternative effective treatment or alternative effective treatment plan rejected by patient (effective treatment refers to the latest version of diagnosis and treatment guidelines for various cancers)
  • 5.At least one resectable lesion (or invaded superficial lymph nodes, or aggregate of lesions resected) of a minimum 0.5cm3 for resection to generate TIL. Minimally invasive surgery is preferred. This lesion cannot be in previously irradiated areas or other local therapy.
  • 6.At least one another measurable target lesion after resection, as defined by RECIST v1.1. Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to screening, and there has been demonstrated disease progression in that particular lesion.
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  • 7.ECOG=0 or 1
  • 8.Estimated life expectancy of ≥ 12 weeks
  • 9.Patients must have adequate organ function:
  • hematologic parameters: Absolute neutrophil count (ANC) ≥ 1.5×109/L Lymphocyte counts（LC）>0.5×109/L Platelet ≥100×109/L Hemoglobin (Hb) ≥ 90g/L
  • AST, ALT and alkaline phosphatase ≤ 2.5 times the upper limit of normal (ULN), TBIL (total bilirubin)≤1.5×ULN, except following:
  • patients with liver metastasis: AST, ALT≤ 5 times ULN; Patients with liver metastasis or bone metastasis: alkaline phosphatase≤5 times ULN; Patients with Gilbert syndrome: TBIL≤3.0 mg/dL; Estimated creatinine clearance (eCrCl) ≥ 45 mL/min using the Cockcroft-Gault formula, or serum creatinine in normal range; d) APTT≤1.5×ULN, while INR or PT≤1.5×ULN; e) LVEF ≥50%; f) FEV1≥60%;
  • 10.Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy. Non surgically sterilized female subjects of reproductive age must be negative for serum hCG testing within 7 days prior to cell infusion;
  • 11.Patients must have recovered from all prior therapy-related adverse events (AEs) to ≤ Grade 1 (per Common Terminology Criteria for Adverse Events [CTCAE] v5.0), except for alopecia or vitiligo, prior to enrollment (tumor resection). Patients with documented ≥ Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and/or had a normal colonoscopy post-immune checkpoint inhibitor treatment, by visual assessment, prior to tumor resection;
  • 12.Before resection, the imaging evidence of disease progress after prior line treatment should be documented.

Who cannot join

  • 1. Patients with symptomatic and/or untreated CNS metastases (Patients with definitively treated brain metastases may be considered for enrollment and must be stable for ≥ 14 days without drug treatment and steroid-dependent) ;
  • 2. Failure of surgery and / or radiotherapy to relieve spinal cord compression;
  • 3. Uncontrolled tumor related pain judged by the investigator. Subjects requiring pain medication must have had a stable pain medication regimen at the time of enrollment; symptomatic lesions amenable to palliative radiotherapy should have completed treatment before enrollment;
  • 4. Interstitial pneumonia or clinically significant active pneumonia, or other respiratory disease severely affecting lung function;
  • 5. Any active autoimmune disease; a history of autoimmune disease or disease requiring treatment with systemic steroids or immunosuppressive drugs;
  • 6. Patients with a history of significant cardiovascular disease, including: 1) Congestive heart failure (NYHA functional classification > Class 2); 2) Unstable angina; 3) myocardial infarction occurred in past 3 months; 4) Any supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;
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  • 7. Arterial/venous thrombotic events within 5 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
  • 8. Patients with active tuberculosis infection within 1 year before enrollment, or with a history of active tuberculosis infection beyond 1 year before but without standard treatment;
  • 9. Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5℃ occurring during the screening period, except for tumor fever;
  • 10. Patients with a history of immunodeficiency, including HIV seropositivity;
  • 11. Patients with active hepatitis B or C. Patients with seropositive HBsAg or HBcAb can be enrolled while negative HBV DNA. Patients with seropositive HCV antibody can be enrolled while negative HCV RNA. If potential carriers enrolled, proper anti-virus treatment and regular nucleotide test should be arranged.
  • 12. Patients with intractable or intractable epilepsy, ascites beyond drug control, portal vein tumor thrombus, gastrointestinal bleeding caused by gastric fundus or esophageal varices, increased risk of bleeding caused by portal hypertension, and active gastrointestinal bleeding
  • 13. Patients who have received an organ allograft or prior cell transfer therapy;
  • 14. Patients who have a history of hypersensitivity to any component or excipient of GT202 or other study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
  • 15. Known psychiatric disorders, alcohol, drug or substance abuse;
  • 16. Any disease or condition (any other condition, metabolic disorder, physical exam result, or abnormal laboratory test result) that could lead to reasonable doubt that would prohibit the use of a trial drug, or affect the interpretation of study results, or put the patient at high-risk treatment;
  • 17. Patients who are pregnant or breastfeeding;
  • 18. Other circumstances that investigator assessed could affect the safety of subjects.

Trial locations and contacts

1 site in 1 country.

xin wu, PHD contact

(021)33189900-6529

wuxin_fc@fudan.edu.cn

China1 site, 1 recruiting

  • The Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200000

    xin wu, PHD, 8613764046908, wuxin_fc@fudan.edu.cn

    Recruiting

Other trials in China

About this study

A prospective, open-label, non-randomized, Phase 1 study evaluating autologous tumor infiltrating lymphocyte injection (GT202) in the treatment of metastatic or recurrent Gynecological tumors.

Being tested
Autologous Tumor Infiltrating Lymphocyte Injection (GT202)
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Tumor Infiltrating Lymphocyte Injection (GT202)Biological

    A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. T cells then are manufactured to express mbIL-12. After lymphodepletion, patients are infused with GT202 followed by IL-2.

Study groups in NCT05238818
Study groupRoleWhat they receive
GT202 in Metastatic or Recurrent Gynecological Tumor patientsExperimentalAutologous Tumor Infiltrating Lymphocyte Injection (GT202) will be infused at 1.0×10^8 cells, 5.0×10^8 cells and 2.0×10^9 cells in metastatic or recurrent gynecological tumor patients.
Receives: Biological: Autologous Tumor Infiltrating Lymphocyte Injection (GT202)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Types and incidence of Dose-limiting toxicity (DLT)

    Dose-limiting toxicity (DLT) will be collected and graded according to CTCAE v5.0

    Measured: up to 28 days after GT202 infusion

  2. Types and incidence of adverse events (AEs) ，serious adverse events (SAEs) and adverse events of special interest (AESI)

    AE will be collected and graded according to CTCAE v5.0

    Measured: Up to 2 years after GT202 infusion

  3. Maximum tolerated dose

    Evaluate the Maximum tolerated dose of GT202 in Metastatic or Recurrent Gynecological Tumors patients

    Measured: up to 28 days after GT202 infusion

Secondary outcomes (5)

  1. Overall response rate (ORR)

    ORR will be calculated as the percentage of patients who achieved partial response (PR) or better.

    Measured: up to 6 weeks, 12 weeks, 18 weeks, 24 weeks after GT202 infusion

  2. Duration of Response (DOR)

    Time from first response to disease progression or death from any cause

    Measured: Up to 2 years after GT202 infusion

  3. Progression-free Survival (PFS)

    PFS will be calculated as the time from GT202 infusion to disease progression or death from any cause (whichever occurs first).

    Measured: Up to 2 years after GT202 infusion

  4. Overall Survival (OS)

    Time from GT202 infusion to time of death due to any cause

    Measured: Up to 2 years after GT202 infusion

  5. Disease Control Rate (DCR)

    DCR will be calculated as the percentage of patients who achieved Stable Disease(SD) or better.

    Measured: up to 6 weeks, 12 weeks, 18 weeks, 24 weeks after GT202 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study startMar 2022 (estimated)
  3. Primary completionJan 2024 (estimated)
  4. Study completionJan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238818
Sponsor's protocol ID
FUOBGY2021-196
Status last verified
Jan 2022
First submitted
9 Feb 2022
Last updated
14 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous Tumor Infiltrating Lymphocyte Injection (GT202) in people with Metastatic or Recurrent Gynecological Tumors, run by XinWu at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact xin wu, PHD ((021)33189900-6529, wuxin_fc@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Types and incidence of Dose-limiting toxicity (DLT) (time frame: up to 28 days after GT202 infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05238818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.

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