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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Aged 18-70 years old;
  2. ECOG (Eastern Cooperative Oncology Group) score is 0 or 1;
  3. The case is diagnosed as cervical squamous cell carcinoma, adenosquamous carcinoma or cervical adenocarcinoma;
  4. Patients who have metastasized or relapsed after initial treatment (surgery, chemotherapy or radiotherapy);
  5. HPV (Human Papillomavirus)-DNA test shows HPV16 positive and/or HPV18 positive;
  6. At least one measurable target lesion defined by RECIST v1.1 (Response Evaluation Criteria in Solid Tumours);
  7. 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;
  8. 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;
  9. 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;
  10. 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;
  11. 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;
  12. The subject is able to adhere to the research visit plan and other protocol requirements.

Exclusion Criteria:

  1. Uncontrolled active systemic infection; patients with active viral hepatitis;
  2. Confirmed HIV infection;
  3. The electrocardiogram indicates myocardial ischemia; the left ventricular ejection fraction on ultrasonography of subjects over 40 years old is less than 45%;
  4. Pulmonary function test (spirometry) proves that forced expiratory volume (FEV) 1<65% predicted or forced vital capacity (FVC)<65% predicted;
  5. Patients with a history of COPD (Chronic Obstructive Pulmonary Disease), asthma, or other chronic lung diseases with significant symptoms;
  6. The subject received systemic steroids equivalent to >15 mg/day of prednisone 2 weeks before sampling, except for inhaled steroids;
  7. The patient has hereditary or acquired coagulopathy;
  8. Medical history of organ or hematopoietic stem cell transplantation;
  9. Patients who are pregnant or breastfeeding;
  10. Those who suffer from serious neurological, mental or endocrine diseases, or those who have serious mental diseases that will hinder full informed consent;
  11. 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.
  12. Suffered from other uncured malignant tumors in the past 5 years or at the same time, except skin basal cell carcinoma and thyroid cancer.
  13. There are central nervous system metastases and central nervous system diseases with clinical significance;
  14. Live vaccine was vaccinated 30 days before cell reinfusion;
  15. Patients with a previous history of cell therapy within one year;
  16. Patients with a history of acute drug allergy, especially those who are allergic to immunoglobulin drugs;
  17. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TILs intervention
Biological: TILs
a single center, single-arm, open label, interventional study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai OriginCell Therapeutics Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 9, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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