TILs, Metastatic or Recurrent Cervical CancerEarly Phase 1NCT04674488
TILs for Treatment of Metastatic or Recurrent Cervical Cancer
A Early Phase 1 study testing TILs in people with TILs, Metastatic or Recurrent Cervical Cancer, run by Shanghai OriginCell Therapeutics Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- TILs, Metastatic or Recurrent Cervical Cancer
- What is being tested?
- TILs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2020to 9 Nov 2024
- Phase
- Early 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
- 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);
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai general hospital
Shanghai, Shanghai Municipality, 200080
He Yinyan, 86-21-63240090, amelie0228@126.com
About this study
Official title: 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.
- Being tested
- TILs
- Medical subject headings
- Neoplasm Metastasis, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TILsBiological
a single center, single-arm, open label, interventional study
| Study group | Role | What they receive |
|---|---|---|
| TILs intervention | Experimental | Not described Receives: Biological: TILs |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose limited toxicity, DLT
Safety and tolerability of TILs, as determined by the rate of Dose Limiting Toxicities (DLTs)
Measured: 28 days
Secondary outcomes (5)
Objective Response Rate, ORR
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
Measured: three months
Duration of Response, DOR
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
Measured: two years
Progression-Free Survival, PFS
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
Measured: two years
overall survival, OS
To evaluate overall survival (OS) in patients with recurrent, metastatic cervical carcinoma
Measured: two years
Disease Control Rate, DCR
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start9 Dec 2020
- Primary completion9 Nov 2022 (estimated)
- Study completion9 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TILs, Metastatic or Recurrent Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai OriginCell Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674488
- Sponsor's protocol ID
- OriginCell
- Status last verified
- Dec 2020
- First submitted
- 13 Dec 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: to publish papers
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of TILs Treatment for Metastatic or Recurrent Cervical Cancer
- ClinicalTrials.gov ID
- NCT04674488
- Acronym / sponsor ID
- OriginCell
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai OriginCell Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 9 Nov 2022 (estimated)
- Study completion
- 9 Nov 2024 (estimated)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TILs intervention | Experimental | Biological: TILs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TILsa single center, single-arm, open label, interventional study | Biological | TILs intervention |
Primary outcome
dose limited toxicity, DLT
Time frame: 28 days
Safety and tolerability of TILs, as determined by the rate of Dose Limiting Toxicities (DLTs)
5 secondary outcomes
Objective Response Rate, ORR
Time frame: three months
Duration of Response, DOR
Time frame: two years
Progression-Free Survival, PFS
Time frame: two years
overall survival, OS
Time frame: two years
Disease Control Rate, DCR
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Individual participant dataSharing planned: No. to publish papers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing TILs in people with TILs, Metastatic or Recurrent Cervical Cancer, run by Shanghai OriginCell Therapeutics Co., Ltd. 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 12 inclusion and 17 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 19 Dec 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose limited toxicity, DLT (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2020.