- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04674488
TILs for Treatment of Metastatic or Recurrent Cervical Cancer
December 14, 2020 updated by: Shanghai OriginCell Therapeutics Co., Ltd.
An Exploratory Clinical Study of TILs Treatment for Metastatic or Recurrent Cervical Cancer
Prospective, single center, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic cervical carcinoma.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Early 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 Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200080
- Recruiting
- Shanghai General Hospital
-
Contact:
- He Yinyan
- Phone Number: 86-21-63240090
- Email: amelie0228@126.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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Aged 18-70 years old;
- ECOG (Eastern Cooperative Oncology Group) score is 0 or 1;
- The case is diagnosed as cervical squamous cell carcinoma, adenosquamous carcinoma or cervical adenocarcinoma;
- Patients who have metastasized or relapsed after initial treatment (surgery, chemotherapy or radiotherapy);
- HPV (Human Papillomavirus)-DNA test shows HPV16 positive and/or HPV18 positive;
- At least one measurable target lesion defined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumours);
- The subject must have a lesion with a diameter of more than 10 mm and a volume of 1.5 cm3 or more (or a collection of resected lesions greater than or equal to 1.5 cm3). TILs can be separated after resection or malignant effusion;
- Routine blood testing reaches the following indicators: neutrophils ≥ 1.5×10^9/L, PLT ≥60×10^9/L, Hb ≥9.0 g/dL, LY ≥0.4×10^9/L;
- Liver and kidney function: ALT (Alanine Aminotransferase, alanine aminotransferase) or AST (Aspartate Aminotransferase, aspartate aminotransferase) index <2.5 times the normal value; creatinine clearance rate>50 ml/min; total bilirubin <1.5 times the normal value, Prothrombin time prolonged ≤ 4 s;
- The treatment methods for malignant tumors, including radiotherapy, chemotherapy and biological agents (including granulocyte colony stimulating factor G-CSF, targeted drug therapy, etc.), must be stopped 28 days before the TILs are obtained;
- Subjects with reproductive potential must be willing to implement the approved high-efficiency contraceptive method with informed consent and continue to implement it within 1 year after the completion of the clinical trial;
- The subject is able to adhere to the research visit plan and other protocol requirements.
Exclusion Criteria:
- Uncontrolled active systemic infection; patients with active viral hepatitis;
- Confirmed HIV infection;
- The electrocardiogram indicates myocardial ischemia; the left ventricular ejection fraction on ultrasonography of subjects over 40 years old is less than 45%;
- Pulmonary function test (spirometry) proves that forced expiratory volume (FEV) 1<65% predicted or forced vital capacity (FVC)<65% predicted;
- Patients with a history of COPD (Chronic Obstructive Pulmonary Disease), asthma, or other chronic lung diseases with significant symptoms;
- The subject received systemic steroids equivalent to >15 mg/day of prednisone 2 weeks before sampling, except for inhaled steroids;
- The patient has hereditary or acquired coagulopathy;
- Medical history of organ or hematopoietic stem cell transplantation;
- Patients who are pregnant or breastfeeding;
- Those who suffer from serious neurological, mental or endocrine diseases, or those who have serious mental diseases that will hinder full informed consent;
- The medical history of primary immunodeficiency, past immune system diseases includes autoimmune diseases that are active, or previously known or suspected to exist autoimmune diseases. Except for side effects of checkpoint inhibitors, vitiligo, psoriasis, type 1 diabetes, remission of childhood asthma, and remission of atopic side effects.
- Suffered from other uncured malignant tumors in the past 5 years or at the same time, except skin basal cell carcinoma and thyroid cancer.
- There are central nervous system metastases and central nervous system diseases with clinical significance;
- Live vaccine was vaccinated 30 days before cell reinfusion;
- Patients with a previous history of cell therapy within one year;
- Patients with a history of acute drug allergy, especially those who are allergic to immunoglobulin drugs;
- Any other conditions judged by the researcher will significantly increase the risk of participation.
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: TILs intervention
|
a single center, single-arm, open label, interventional study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dose limited toxicity, DLT
Time Frame: 28 days
|
Safety and tolerability of TILs, as determined by the rate of Dose Limiting Toxicities (DLTs)
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate, ORR
Time Frame: three months
|
To evaluate the efficacy of TILs in patients with recurrent, metastatic cervical carcinoma based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
|
three months
|
Duration of Response, DOR
Time Frame: two years
|
To evaluate the efficacy parameters of TILs in patients with recurrent, metastatic cervical carcinoma by assessing duration of response (DOR) as assessed by the IRC per RECIST v1.1
|
two years
|
Progression-Free Survival, PFS
Time Frame: two years
|
To evaluate the efficacy parameters of TILs in patients with recurrent, metastatic cervical carcinoma by assessing progression-free survival (PFS) as assessed by the IRC per RECIST v1.1
|
two years
|
overall survival, OS
Time Frame: two years
|
To evaluate overall survival (OS) in patients with recurrent, metastatic cervical carcinoma
|
two years
|
Disease Control Rate, DCR
Time Frame: two years
|
To evaluate the efficacy of TILs in patients with recurrent, metastatic cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per RECIST v1.1
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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)
December 9, 2020
Primary Completion (Anticipated)
November 9, 2022
Study Completion (Anticipated)
November 9, 2024
Study Registration Dates
First Submitted
December 13, 2020
First Submitted That Met QC Criteria
December 14, 2020
First Posted (Actual)
December 19, 2020
Study Record Updates
Last Update Posted (Actual)
December 19, 2020
Last Update Submitted That Met QC Criteria
December 14, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OriginCell
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
to publish papers
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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