Cervical CarcinomaPhase 1/2NCT05357027
HPV16 E6 TCR T Cells for Cervical Carcinoma
A Phase 1/2 study testing TC-E202 cells, IL-2 and Fludarabine in people with Cervical Carcinoma, run by TCRCure Biopharma Ltd. at 1 site in China.
Trial summary
Background: Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection. Cancer cells infected by HPV expressing an HPV protein called E6. E6 is the main factors of HPV 16 carcinogenesis. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Carcinoma
- What is being tested?
- TC-E202 cells, IL-2 and Fludarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2022to 15 Jan 2026
- Phase
- Phase 1/2
- 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
- Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial.
- Age ≥ 18 years and ≤ 70 years.
- Expected survival time > 3 months.
- ECOG score 0-1.
- Recurrent or metastatic cervical carcinoma based on TNM \& FIGO staged histopathological investigation.
- Received at least second-line standard treatment and diagnosed as PD through image assessment. (previously received radio-therapy, chemo-therapy, targeted-therapy or immune-therapy, wash-out period > 14 or 5 half life)
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- Be able provide fresh or preserved tissue specimen. (fresh specimen first, paraffine specimen or at least 12 tumor section, tumor tissue >20%)
- At least 1 measurable lesion (according to RECIST1.1 standard）.
- HPV16 positive.
- HLA-A2 positive.
- Hematology should at least meet the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5× 109/L (±20%)； Platelet (PLT） ≥ 75× 109/L (±20%）； Hemoglobin (HGB) ≥ 90 g/L (±20%).
- Blood biochemistry should at least meet the following criteria:
- Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min; Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal; Total bilirubin (TBIL) ≤ 15 times of upper limit of normal.
- Blood coagulation function is normal: Prothrombin time (PT) ≤ 1.5 ULN, International Normalized Ratio (INR) ≤ 1.5 ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN.
- Women of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug.
- Recovered from toxic effect of previous treatment (CTCAE ≤ 1), or related AE(s) is not defined as safety issue.
- Catheter insertion is feasible and No White Blood Cells collection contraindications.
Who cannot join
- Under pregnancy or lactation, or positive based on blood pregnancy test.
- Severe allergic to related ingredients in the clinical trial.
- Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time (exception: the other treatment is observational and non-investigational or the patient is under follow-up period)
- Primary central nerve system (CNS) cancer, or subjects with CNS metastasis after localized treatment (except patients without CNS metastasis, clinically stable and neither steroid treatment nor treatment for CNS metastasis).
- Patients with active autoimmune disease or require systemic steroid treatment. (except patients with cutaneous condition but without systemic treatment, or subjects with asthma in childhood but without intervention after grown-up, or subjects with hypothyroidism mediated by autoimmune dysfunction and receiving thyroxine as replaced treatment)
- Immunodeficiency including HIV positive, harvested or natural immunodeficiency.
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- Patients with ≥ grade 3 thromboembolic events within 2 years or under thrombolysis treatment.
- Patients with hereditary or acquired hemorrhagic disease
- Patients with cardiovascular disease or symptoms:
- congestive heart failure (NYHA > 2); history of unstable angina pectoris; miocardial infarction within 48 weeks; clinically significant malignant arrhythmia (except atrial fibrillation and paroxysmal supraventricular tachycardia); Clinically significant prolonged QTcF (Male QTcF > 450 msec, Female QTcF > 470 msec); Uncontrolled hypertension.
- Patients under active infection (except subjects with fever caused by tumor)
- Patients with active tuberculosis, or history of active tuberculosis within 1 year before enrollment, or history of active tuberculosis over a year before enrollment but without standard treatment.
- Patient with Active Hepatitis B or Active Hepatitis C.
- Treponema pallidum antibody positive.
- Received major surgery or under severe injury within 4 weeks before enrollment.
- History of drug abuse, alcohol or drug addiction.
- Received cell therapy before enrollment，such as TCR-T，CAR-T and TIL .
- Allergic to IL-2.
- Received treatment related chemo-therapy within 14 days of TC-E202 infusion (except lymphodepletion) .
- Patient not suitable for the clinical trial according to investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Clinical Trail of TC-E202 Targeting HPV16 E6 for Relapsed/Refractory to Standard Treatment or Metastatic Cervical Carcinoma
Background:
Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection. Cancer cells infected by HPV expressing an HPV protein called E6. E6 is the main factors of HPV 16 carcinogenesis. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting HPV E6. The genetically engineered cells are called E6 TCR-T cells. The engineered cells are re-infused in the patients with cervical carcinoma.
Read more
Objective:
To evaluate the safety and efficacy of TCR-T cells in the treatment of cervical carcinoma.
Eligibility:
Adults aging 18-70 with relapsed/refractory to standard treatment or metastatic cervical carcinoma.
Design:
Patients will have many screening tests, including imaging procedures, heart and lung tests, and lab tests.
Patients will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.
Engineered T cells will be re-infused into the patients will stay in hospital and be evaluated.
Read the detailed description
Background:
Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection.
Cancer cells infected by HPV expressing an HPV protein called E6. E6 is the main factors of HPV 16 carcinogenesis. T cells genetically engineered with a TCR targeting HPV-16 E6 (E6 TCR) display specific reactivity against HLA-A2+, HPV-16+ target cells.
T cell receptor (TCR) gene engineered T cells infusion can induce objective tumor responses in certain malignancies including HPV-16+ cancer.
Objective:
Phase I: Determine the safety and tolerability of TC-E202 inHPV16 positive patients with relapsed/refractory to standard treatment or metastatic cervical carcinoma and determine the Recommended Phase II Dose (RPIID).
Primary endpoints: safety and tolerability. The evaluation of safety and tolerability will be based on the following endpoints: 1) Whether DLT occurs or MTD is achieved; 2) The incidence of various adverse events and serious adverse events and their relationship with TCR-T, IL-2, lymphodepletion chemotherapy and leukapheresis.
Secondary endpoints: efficacy. Objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were assessed based on RECIST 1.1 and iRECIST.
Eligibility:
Adults aging 18-70 with relapsed/refractory to standard treatment or metastatic cervical carcinoma.
Eligible patients were HLA-A*02 and had metastatic HPV16-positive cervical cancer. Patients had received or declined previous systemic therapy, with more than 4 weeks elapsed since previous systemic treatment. Patients had an Eastern Cooperative Oncology Group performance score of 0 or 1 and adequate hematologic, hepatic, and renal function.
Design:
This is a Phase I/II clinical trial to evaluate the efficacy and safety of TC-E202.
Dose escalation will proceed according to 3+3 procedure. All patients will receive a lymphocyte-depleting preparative regimen of cyclophosphamide and fludarabine followed by an infusion of E6 TCR (TC-E202) cells. Cell infusion will be followed by IL-2 administration.
All patents will be evaluated based on ORR according to RECIST v1.1\&iRECIST. Phase I clinical trials establish a Drug Safety Review Committee (SRC), and the SRC will hold regular and irregular meetings to evaluate the safety data of the subjects, the clinical pharmacology, along with associated clinical efficacy, to decide escalating dose and RPIID. In addition, the SRC will decide whether to explore higher or lower doses than planned doses based on specific data.
- Conditions
- Cervical Carcinoma
- Being tested
- TC-E202 cells, IL-2, Fludarabine, Cyclophosphamide Capsules
- Keywords
- HPV16 E6, TCR T Cells, Cervical Carcinoma
- 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.
TC-E202 cellsBiological
Also called TCR T Cells
T cells genetically engineered with a TCR targeting HPV16 E6 (E6 TCR) that display specific reactivity against HLA-A2+, HPV-16+ target cells
IL-2Drug
Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance. IL-2 improves the survival of TC-E202 cells after infusion.
FludarabineDrug
Part of the non-myeloablative lymphocyte-depleting preparative regimen.
Cyclophosphamide CapsulesDrug
Part of the non-myeloablative lymphocyte-depleting preparative regimen.
| Study group | Role | What they receive |
|---|---|---|
| TC-E202 dose | Experimental | This study uses the "3+3" dose escalation method. The initial dose is Dose1, the maximum dose that patients can tolerate is determined as the phase II recommended dose (RPIID), and at least 6 patients are receiving RPIID treatment . If patients develop intolerance in Dose 1 (≥3 subjects with DLT), then the subsequent enrolled patients will receive Dose-1 infusion. Receives: Biological: TC-E202 cells; Drug: IL-2; Drug: Fludarabine; Drug: Cyclophosphamide Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD)
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by SRC, and should be possibly related to TC-E202 cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication.
The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.
Measured: Day 28 after the first TC-E202 infusion
Overall response rate
The efficacy of TC-E202 will be assessed by the objective response rate (ORR) is evaluated according to RECIST 1.1 and iRECIST. ORR is described as patients assessed with partial response (PR) and complete response (CR).
Measured: Day0-Day730
Treatment-related adverse events as assessed by CTCAE v5.0
The type, incidence and severity of adverse events include abnormal laboratory examination results with clinical significance after treatment, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory adverse events will be classified according to the National Cancer Institute general terminology standard for adverse events (NCI CTCAE) version 5.0.
Measured: Day0-Day730
Secondary outcomes (7)
Duration of response
The efficacy of TC-E202 will be assessed by duration of response (DOR). The DOR refers to the length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.
Measured: Day0-Day730
Progression free survival
The efficacy of TC-E202 will be assessed by progression free survival (PFS). The PFS refers to the time from treatment to progressive disease or death for any reason.
Measured: Day0-Day730
Overall survival
The efficacy of TC-E202 will be assessed by overall survival (OS). The OS refers to the time from treatment to death.
Measured: Day0-Day730
Maximum Persistence (Cmax) of TC-E202
Blood samples were collected to measure persistence of infused TC-E202 using polymerase chain reaction of a vector specific sequence in deoxyribonucleic acid (DNA) extracted from peripheral blood mononuclear cell (PBMC).
Measured: Day0-Day730
Time to Maximum Persistence
Blood samples were collected to measure persistence of infused TC-E202 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC.
Measured: Day0-Day730
Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC[0-28])
Blood samples were collected to measure persistence of infused TC-E202 using polymerase chain reaction of a vector specific sequence in DNA extracted from PBMC.
Measured: Day 28 after the first TC-E202 infusion
Anti-PD-1 single chain antibody concentration
The pharmacodynamics of TC-E202 will be assessed by Anti-PD-1 single chain antibody content.
Measured: Day0-Day730
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start10 Aug 2022
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Why it stopped: Study terminated due to strategic portfolio decision to reallocate resources to higher-priority programs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CarcinomaStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCRCure Biopharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Responsible party
- Sponsor
- Investigators
- XiaoHua Wu, doctor, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357027
- Sponsor's protocol ID
- TC-E202-CC-PI
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2022
- Last updated
- 21 Jan 2026
- Results posted
- 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 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trail of TC-E202 Targeting HPV16 E6 for Relapsed/Refractory to Standard Treatment or Metastatic Cervical Carcinoma
- ClinicalTrials.gov ID
- NCT05357027
- Acronym / sponsor ID
- TC-E202-CC-PI
- Conditions
- Cervical Carcinoma
- Keywords
- HPV16 E6, TCR T Cells, Cervical Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to strategic portfolio decision to reallocate resources to higher-priority programs
- Enrolment
- 5 participants (actual)
- Lead sponsor
- TCRCure Biopharma Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Fudan University
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 2 May 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.
Background:
Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection. Cancer cells infected by HPV expressing an HPV protein called E6. E6 is the main factors of HPV 16 carcinogenesis. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting HPV E6. The genetically engineered cells are called E6 TCR-T cells. The engineered cells are re-infused in the patients with cervical carcinoma.
Objective:
To evaluate the safety and efficacy of TCR-T cells in the treatment of cervical carcinoma.
Eligibility:
Adults aging 18-70 with relapsed/refractory to standard treatment or metastatic cervical carcinoma.
Design:
Patients will have many screening tests, including imaging procedures, heart and lung tests, and lab tests.
Patients will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm.
Engineered T cells will be re-infused into the patients will stay in hospital and be evaluated.
Detailed description
Background:
Cervical cancer is the most common gynecologic malignant tumor. The occurrence and progression of cervical carcinoma is firmly relevant to HPV (Human papilloma virus) infection.
Cancer cells infected by HPV expressing an HPV protein called E6. E6 is the main factors of HPV 16 carcinogenesis. T cells genetically engineered with a TCR targeting HPV-16 E6 (E6 TCR) display specific reactivity against HLA-A2+, HPV-16+ target cells.
T cell receptor (TCR) gene engineered T cells infusion can induce objective tumor responses in certain malignancies including HPV-16+ cancer.
Objective:
Phase I: Determine the safety and tolerability of TC-E202 inHPV16 positive patients with relapsed/refractory to standard treatment or metastatic cervical carcinoma and determine the Recommended Phase II Dose (RPIID).
Primary endpoints: safety and tolerability. The evaluation of safety and tolerability will be based on the following endpoints: 1) Whether DLT occurs or MTD is achieved; 2) The incidence of various adverse events and serious adverse events and their relationship with TCR-T, IL-2, lymphodepletion chemotherapy and leukapheresis.
Secondary endpoints: efficacy. Objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were assessed based on RECIST 1.1 and iRECIST.
Eligibility:
Adults aging 18-70 with relapsed/refractory to standard treatment or metastatic cervical carcinoma.
Eligible patients were HLA-A*02 and had metastatic HPV16-positive cervical cancer. Patients had received or declined previous systemic therapy, with more than 4 weeks elapsed since previous systemic treatment. Patients had an Eastern Cooperative Oncology Group performance score of 0 or 1 and adequate hematologic, hepatic, and renal function.
Design:
This is a Phase I/II clinical trial to evaluate the efficacy and safety of TC-E202.
Dose escalation will proceed according to 3+3 procedure. All patients will receive a lymphocyte-depleting preparative regimen of cyclophosphamide and fludarabine followed by an infusion of E6 TCR (TC-E202) cells. Cell infusion will be followed by IL-2 administration.
All patents will be evaluated based on ORR according to RECIST v1.1\&iRECIST. Phase I clinical trials establish a Drug Safety Review Committee (SRC), and the SRC will hold regular and irregular meetings to evaluate the safety data of the subjects, the clinical pharmacology, along with associated clinical efficacy, to decide escalating dose and RPIID. In addition, the SRC will decide whether to explore higher or lower doses than planned doses based on specific data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TC-E202 dose | Experimental | Biological: TC-E202 cells, Drug: IL-2, Drug: Fludarabine, Drug: Cyclophosphamide CapsulesThis study uses the "3+3" dose escalation method. The initial dose is Dose1, the maximum dose that patients can tolerate is determined as the phase II recommended dose (RPIID), and at least 6 patients are receiving RPIID treatment . If patients develop intolerance in Dose 1 (≥3 subjects with DLT), then the subsequent enrolled patients will receive Dose-1 infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial.
- Age ≥ 18 years and ≤ 70 years.
- Expected survival time > 3 months.
- ECOG score 0-1.
- Recurrent or metastatic cervical carcinoma based on TNM \& FIGO staged histopathological investigation.
Key exclusion criteria (20 listed)
- Under pregnancy or lactation, or positive based on blood pregnancy test.
- Severe allergic to related ingredients in the clinical trial.
- Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time (exception: the other treatment is observational and non-investigational or the patient is under follow-up period)
- Primary central nerve system (CNS) cancer, or subjects with CNS metastasis after localized treatment (except patients without CNS metastasis, clinically stable and neither steroid treatment nor treatment for CNS metastasis).
- Patients with active autoimmune disease or require systemic steroid treatment. (except patients with cutaneous condition but without systemic treatment, or subjects with asthma in childhood but without intervention after grown-up, or subjects with hypothyroidism mediated by autoimmune dysfunction and receiving thyroxine as replaced treatment)
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 |
|---|---|---|
| TC-E202 cellsAlso: TCR T CellsT cells genetically engineered with a TCR targeting HPV16 E6 (E6 TCR) that display specific reactivity against HLA-A2+, HPV-16+ target cells | Biological | TC-E202 dose |
| IL-2Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance. IL-2 improves the survival of TC-E202 cells after infusion. | Drug | TC-E202 dose |
| FludarabinePart of the non-myeloablative lymphocyte-depleting preparative regimen. | Drug | TC-E202 dose |
| Cyclophosphamide CapsulesPart of the non-myeloablative lymphocyte-depleting preparative regimen. | Drug | TC-E202 dose |
Primary outcome
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD)
Time frame: Day 28 after the first TC-E202 infusion
Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by SRC, and should be possibly related to TC-E202 cell therapy, and should be unrelated to the disease itself, disease progression, concomitant diseases or concomitant medication. The MTD is the highest dose at which ≤1 of 6 patients experienced a dose limiting toxicity (DLT) or the highest dose level studied if DLTs are not observed at any of the dose levels.
Overall response rate
Time frame: Day0-Day730
The efficacy of TC-E202 will be assessed by the objective response rate (ORR) is evaluated according to RECIST 1.1 and iRECIST. ORR is described as patients assessed with partial response (PR) and complete response (CR).
Treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Day0-Day730
The type, incidence and severity of adverse events include abnormal laboratory examination results with clinical significance after treatment, abnormal physical examination and blood examination results, bone marrow examination results, etc. Clinical and laboratory adverse events will be classified according to the National Cancer Institute general terminology standard for adverse events (NCI CTCAE) version 5.0.
7 secondary outcomes
Duration of response
Time frame: Day0-Day730
Progression free survival
Time frame: Day0-Day730
Overall survival
Time frame: Day0-Day730
Maximum Persistence (Cmax) of TC-E202
Time frame: Day0-Day730
Time to Maximum Persistence
Time frame: Day0-Day730
Area Under the Plasma Concentration-time Curve From Zero to Day 28 (AUC[0-28])
Time frame: Day 28 after the first TC-E202 infusion
Anti-PD-1 single chain antibody concentration
Time frame: Day0-Day730
Results and safety
The study was stopped early (reason given: Study terminated due to strategic portfolio decision to reallocate resources to higher-priority programs). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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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, doctor study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TC-E202 cells, IL-2 and Fludarabine in people with Cervical Carcinoma, run by TCRCure Biopharma 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 18 inclusion and 20 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: stopped early, as of the sponsor's last update on 21 Jan 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to strategic portfolio decision to reallocate resources to higher-priority programs). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity or Maximum Tolerated Dose (MTD) (time frame: Day 28 after the first TC-E202 infusion). The study lists 3 primary outcomes in all. 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 21 Jan 2026.