- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04766320
Study on TIL for the Treatment of r/r Gynecologic Tumors
March 4, 2024 updated by: Zhongping Cheng, Shanghai 10th People's Hospital
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jing Guo, PHD
- Phone Number: +86 21 66307151
- Email: jguo12@foxmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200040
- Recruiting
- Shanghai Tenth People's Hospital
-
Contact:
- Jing Guo, PHD
- Phone Number: +86 21 66307151
- Email: jguo12@foxmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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;
- 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.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tumor Infiltrating Lymphocytes (TIL)
1x10^9-3x10^11 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.
|
Adoptive transfer of 1x10^9-3x10^11 autologous TILs to patients i.v. in 30-120 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 12 months
|
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.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: Up to 36 months
|
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)
|
Up to 36 months
|
Disease Control Rate (DCR)
Time Frame: Up to 36 months
|
Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1
|
Up to 36 months
|
Duration of Response (DOR)
Time Frame: Up to 36 months
|
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
|
Up to 36 months
|
Progression-Free Survival (PFS)
Time Frame: Up to 36 months
|
The time length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
|
Up to 36 months
|
Overall Survival (OS)
Time Frame: Up to 36 months
|
The length of time from the date of the start of TIL treatment that the patients are still alive
|
Up to 36 months
|
Complete Response(CR)
Time Frame: Up to 36 months
|
Patients with complete response per RECIST 1.1 to TIL treatment
|
Up to 36 months
|
Partial Response (PR)
Time Frame: Up to 36 months
|
Percentage of patients with partial response per RECIST 1.1 to TIL treatment
|
Up to 36 months
|
Stable Disease (SD)
Time Frame: Up to 36 months
|
Patients with stable disease per RECIST 1.1 to TIL treatment
|
Up to 36 months
|
Progressive Disease (PD)
Time Frame: Up to 36 months
|
Patients with progressive disease per RECIST 1.1 to TIL treatment
|
Up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2021
Primary Completion (Actual)
December 4, 2022
Study Completion (Estimated)
January 31, 2025
Study Registration Dates
First Submitted
February 19, 2021
First Submitted That Met QC Criteria
February 22, 2021
First Posted (Actual)
February 23, 2021
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- shiyuanfuke000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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