Clinical trial · Interventional
Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer
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
NCT05475847CI-TRIAL-00059943TILunknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection | Biological | Lifileucel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-TIL052A treatment group
- description
- C-TIL052A autologous infiltrating lymphocytes injection followed by injection of Interleukin 2 (IL-2)
- interventionNames
- Biological: Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection
Primary outcomes (1)
- measure
- Adverse Events (AE)
- timeFrame
- up to 12 months or through study completion
- description
- 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.
Secondary outcomes (6)
- measure
- Objective Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Aged 18 to 70 years at screening 2. Voluntary participation and able to sign the informed consent form 3. Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment. 4. Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes 5. At least one measurable target lesion (per RECIST v1.1) 6. ECOG performance status score: 0\~1 7. Expected survival ≥ 3 months 8. Negative serum or urine pregnancy test results for females of child-bearing age at screening Exclusion Criteria: 1. Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease) 2. Symptomic chronic obstructive pulmonary disease or persistent asthma 3. Uncontrolled cardiovascular diseases 4. History of primary immune deficiency, autoimmune disease or chronic inflammatory disease 5. High-risk subjects with rapid tumor progression as judged by the Investigator(s) 6. Complicated with infectious diseases, such as hepatitis B/C, syphilis, AIDS 7. History of organ transplantation or allogeneic cell therapy 8. Any situation judged by the Investigator(s) that will have safety concern or interfere with the study results
References
Publications (0)
Data not yet available
No reference posted for this study.