Cervical CancerPhase 1TILNCT05475847
Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer
A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection in people with Cervical Cancer, run by Fudan University at 2 sites in China.
Trial summary
A study that aimed to assess the safety and anti-tumor activity of C-TIL052A cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2022to Jul 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years at screening
- Voluntary participation and able to sign the informed consent form
- Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment.
- Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes
- At least one measurable target lesion (per RECIST v1.1)
- ECOG performance status score: 0~1
- Expected survival ≥ 3 months
- Negative serum or urine pregnancy test results for females of child-bearing age at screening
Who cannot join
- Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease)
- Symptomic chronic obstructive pulmonary disease or persistent asthma
- Uncontrolled cardiovascular diseases
- History of primary immune deficiency, autoimmune disease or chronic inflammatory disease
- High-risk subjects with rapid tumor progression as judged by the Investigator(s)
- Complicated with infectious diseases, such as hepatitis B/C, syphilis, AIDS
- History of organ transplantation or allogeneic cell therapy
- Any situation judged by the Investigator(s) that will have safety concern or interfere with the study results
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District
Shanghai, Shanghai Municipality, 200032
Xiaohua Wu, MD, Ph.D, 021-64175590-82900, docwxh@hotmail.com
- Recruiting
Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area
Shanghai, Shanghai Municipality, 201315
Jian Zhang, MD, Ph.D, 021-64175590-73546, Syner2000@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer
A study that aimed to assess the safety and anti-tumor activity of C-TIL052A cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer.
Read the detailed description
For patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. The study is a single center phase I trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of C-TIL052A cell therapy in persistent, recurrent and/or metastatic cervical cancer. Eligible subjects will receive injection of C-TIL052A (Autologous Tumor Infiltrating Lymphocytes, TIL) and interleukin 2 (IL-2) after lymphodepletion. All subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.
- Conditions
- Cervical Cancer
- Being tested
- Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection
- Keywords
- Gynecological tumor, Tumor Infiltrating Lymphocytes
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) InjectionBiological
C-TIL052A injection followed by injection of IL-2
| Study group | Role | What they receive |
|---|---|---|
| C-TIL052A treatment group | Experimental | C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2) Receives: Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
To characterize the safety profile and evaluate tolerability of C-TIL052A cell therapy by collecting, analyzing the treatment emergent adverse events (TEAEs) and adverse events of special interest (AESIs) during and post treatment, especially the incidence and severity of adverse events (AE) within 28 days post TIL infusion.
Measured: up to 12 months or through study completion
Secondary outcomes (6)
Objective Response Rate (ORR)
Proportion of patients with response (CR+PR) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Measured: up to 12 months or through study completion
Disease Control Rate (DCR)
Proportion of patients ever comfirmed with response or stable disease (CR+PR+SD) during the follow-up period per RECIST v1.1
Measured: up to 12 months or through study completion
Duration of Response (DOR)
The time length between the first confirmed objective response to the treatment and the subsequent disease progression per RECIST 1.1
Measured: up to 12 months or through study completion
Time to Response (TTR)
The time length between TIL infusion and confirmed subsequent disease progression per RECIST 1.1
Measured: up to 12 months or through study completion
Overall Survival（OS）
The time length of patients living from the date of TIL infusion
Measured: up to 12 months or through study completion
Progression Free Survival（PFS）
The time length of patients living without progression from the date of TIL infusion
Measured: up to 12 months or through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Principal investigator, Xiaohua Wu MD, Fudan University
- Investigators
- Xiaohua Wu, MD, Ph.D, Principal investigator, Fudan UniversityJian Zhang, MD, Ph.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475847
- Sponsor's protocol ID
- 1031-031
- Acronym
- TIL
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate Safety and Efficacy of C-TIL052A Cell Therapy (Autologous Tumor Infiltrating Lymphocytes Injection Combined With IL-2) in Subjects With Persistent, Recurrent and/or Metastatic Cervical Cancer
- ClinicalTrials.gov ID
- NCT05475847
- Acronym / sponsor ID
- TIL / 1031-031
- Conditions
- Cervical Cancer
- Keywords
- Gynecological tumor, Tumor Infiltrating Lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Jul 2022 (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.
A study that aimed to assess the safety and anti-tumor activity of C-TIL052A cell therapy in subjects with persistent, recurrent and/or metastatic cervical cancer.
Detailed description
For patients with advanced cervical cancer who have failed the standard treatment, no recognized alternative follow-up treatment regimens are available and the prognosis is poor. The study is a single center phase I trial planning to assess the safety, tolerability and the preliminary anti-tumor activity of C-TIL052A cell therapy in persistent, recurrent and/or metastatic cervical cancer. Eligible subjects will receive injection of C-TIL052A (Autologous Tumor Infiltrating Lymphocytes, TIL) and interleukin 2 (IL-2) after lymphodepletion. All subjects will be followed up post treatment for safety and efficacy monitoring and the follow-up period will be 12 months or through study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-TIL052A treatment group | Experimental | Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) InjectionC-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 70 years at screening
- Voluntary participation and able to sign the informed consent form
- Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment.
- Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes
- At least one measurable target lesion (per RECIST v1.1)
Key exclusion criteria (8 listed)
- Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease)
- Symptomic chronic obstructive pulmonary disease or persistent asthma
- Uncontrolled cardiovascular diseases
- History of primary immune deficiency, autoimmune disease or chronic inflammatory disease
- High-risk subjects with rapid tumor progression as judged by the Investigator(s)
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 |
|---|---|---|
| Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) InjectionC-TIL052A injection followed by injection of IL-2 | Biological | C-TIL052A treatment group |
Primary outcome
Adverse Events (AE)
Time frame: up to 12 months or through study completion
To characterize the safety profile and evaluate tolerability of C-TIL052A cell therapy by collecting, analyzing the treatment emergent adverse events (TEAEs) and adverse events of special interest (AESIs) during and post treatment, especially the incidence and severity of adverse events (AE) within 28 days post TIL infusion.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: up to 12 months or through study completion
Disease Control Rate (DCR)
Time frame: up to 12 months or through study completion
Duration of Response (DOR)
Time frame: up to 12 months or through study completion
Time to Response (TTR)
Time frame: up to 12 months or through study completion
Overall Survival（OS）
Time frame: up to 12 months or through study completion
Progression Free Survival（PFS）
Time frame: up to 12 months or through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
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.
Xiaohua Wu, MD, Ph.D principal investigator
Fudan University
Jian Zhang, MD, Ph.D principal investigator
Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection in people with Cervical Cancer, run by Fudan University at 2 sites 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 8 inclusion and 8 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Xiaohua Wu, MD, Ph.D (021-64175590-82900, docwxh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AE) (time frame: up to 12 months or through study completion). 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 28 Jul 2022.