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Gynecologic CancerPhase 1NCT04766320

Study on TIL for the Treatment of r/r Gynecologic Tumors

A Phase 1 study testing Tumor Infiltrating Lymphocytes (TIL) in people with Gynecologic Cancer, run by Shanghai 10th People's Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gynecologic tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Gynecologic Cancer
What is being tested?
Tumor Infiltrating Lymphocytes (TIL)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
4 Jan 2021to 31 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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: 18 years to 75 years;
  • Histologically diagnosed as primary/relapsed/metastasized malignant tumors;
  • Expected life-span more than 3 months;
  • Karnofsky≥60% or ECOG score 0-2;
  • Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
  • Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
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  • At least 1 evaluable tumor lesion;
  • Absolute count of white blood cells≥2.5×10^9/L, absolute count of neutropils≥1.5×10^9/L, platelet count≥100×10^9, hemoglobin≥90 g/L;
  • Serum creatinine clearance 50mL/min or higher; creatinine≤1.5×ULN; ALT/AST less than three times that of normal group, ALT/AST of test subjects with liver metastasis less than five times that of normal group; bilirubin≤1.5×ULN;
  • Activated partial thromboplastin time (APTT) less than or equal to 1.5xULN; international normalized ratio (INR) less than or equal to 1.5xULN;
  • Enough venous accessibility, no absolute or relative contraindications to operation or biopsy;
  • Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletion；
  • Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;
  • Be able to understand and sign the informed consent document;
  • Be able to stick to follow-up visit plan and other requirements in the agreement.

Who cannot join

  • Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones);
  • Autoimmune diseases requiring immunomodulatory treatment;
  • Serum creatinine >1.5×ULN; serum glutamic-oxalacetic transaminase (SGOT) greater than 5×ULN; bilirubin >1.5×ULN;
  • Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;
  • Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
  • Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;
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  • Severe physical or mental diseases;
  • Blood culture positive or imaging proof;
  • Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy;
  • History of allergy to chemical compound consisting of chemical and biologic substances resembling cell therapy;
  • Having received immunotherapy and developed irAE level greater than Level 3;
  • Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded);
  • Females in pregnancy or lactation;
  • Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.

Trial locations and contacts

1 site in 1 country.

Jing Guo, PHd contact

+86 21 66307151

jguo12@foxmail.com

China1 site, 1 recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200040

    Jing Guo, PHD, +86 21 66307151, jguo12@foxmail.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Safety and Efficacy Study on TIL for the Treatment of r/r Gynecologic Tumors

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gynecologic tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.

Being tested
Tumor Infiltrating Lymphocytes (TIL)

What participants receive

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

  • Tumor Infiltrating Lymphocytes (TIL)Biological

    Adoptive transfer of 1x10^9-3x10^11 autologous TILs to patients i.v. in 30-120 minutes.

Study groups in NCT04766320
Study groupRoleWhat they receive
Tumor Infiltrating Lymphocytes (TIL)Experimental1x10^9-3x10^11 in vitro expanded autologous TILs will be infused i.v. to patients with relapsed/refractory malignant gynecological tumors after NMA lymphodepletion treatment with fludarabine and cyclophosphamide. PD-1 checkpoint inhibitor would be applied as combination treatment to those patients.
Receives: Biological: Tumor Infiltrating Lymphocytes (TIL)

What is being measured

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

  1. Incidence of Serious Adverse Events (SAEs)

    Safety assessments. Incidence of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs). The severity of all adverse events was graded based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

    Measured: Up to 12 months

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    To evaluate the efficacy of TIL infusion in patients as determined by objective response rate (ORR), which contains complete response (CR) and partial response (PR), using the RECIST v1.1, as assessed by the Investigator. ( CT Scan at 4-6 weeks after TIL infusion, and than every 4-6 weeks for 1 year, and then every six months after that for up to 3 years)

    Measured: Up to 36 months

  2. Disease Control Rate (DCR）

    Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1

    Measured: Up to 36 months

  3. Duration of Response (DOR)

    The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1

    Measured: Up to 36 months

  4. Progression-Free Survival (PFS)

    The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1

    Measured: Up to 36 months

  5. Overall Survival (OS)

    The length of time from the date of the start of TIL treatment that the patients are still alive

    Measured: Up to 36 months

  6. Complete Response(CR)

    Patients with complete response per RECIST 1.1 to TIL treatment

    Measured: Up to 36 months

  7. Partial Response (PR)

    Percentage of patients with partial response per RECIST 1.1 to TIL treatment

    Measured: Up to 36 months

  8. Stable Disease (SD)

    Patients with stable disease per RECIST 1.1 to TIL treatment

    Measured: Up to 36 months

  9. Progressive Disease (PD)

    Patients with progressive disease per RECIST 1.1 to TIL treatment

    Measured: Up to 36 months

Timeline

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

  1. First posted23 Feb 2021
  2. Study start4 Jan 2021
  3. Primary completion4 Dec 2022
  4. Study completion31 Jan 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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04766320
Sponsor's protocol ID
shiyuanfuke000
Status last verified
Mar 2024
First submitted
19 Feb 2021
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo J, Wang C, Luo N, Wu Y, Huang W, Zhu J, Shi W, Ding J, Ge Y, Liu C, Lu Z, Bast RC Jr, Ai G, Yang W, Wang R, Li C, Chen R, Liu S, Jin H, Zhao B, Cheng Z. IL-2-free tumor-infiltrating lymphocyte therapy with PD-1 blockade demonstrates potent efficacy in advanced gynecologic cancer. BMC Med. 2024 May 20;22(1):207. doi: 10.1186/s12916-024-03420-0.

    PubMed 38769543

  • Guo J, Luo N, Ai G, Yang W, Zhu J, Li C, Chen R, Zhang C, Liu S, Jin H, Cheng Z. Eradicating tumor in a recurrent cervical cancer patient with autologous tumor-infiltrating lymphocytes and a modified lymphodepleting regimen. J Immunother Cancer. 2022 Feb;10(2):e003887. doi: 10.1136/jitc-2021-003887.

    PubMed 35177415

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tumor Infiltrating Lymphocytes (TIL) in people with Gynecologic Cancer, run by Shanghai 10th People's Hospital 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 14 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 6 Mar 2024. 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 Jing Guo, PHd (+86 21 66307151, jguo12@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Serious Adverse Events (SAEs) (time frame: Up to 12 months). 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 NCT04766320, which also lists 2 linked publications.

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 6 Mar 2024.

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