C-TIL052A cell therapy for advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I trial evaluates the safety and anti-tumor activity of C-TIL052A cell therapy in patients with advanced cervical cancer who have not responded to standard treatments. Participants will receive injections of autologous tumor infiltrating lymphocytes (TIL) along with interleukin 2 (IL-2) following a lymphodepletion process. The study aims to monitor the safety and efficacy of this treatment over a follow-up period of 12 months. The trial is conducted at a single center, focusing on patients with persistent, recurrent, or metastatic cervical cancer.

Why it matters

Who can join: the full rules

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

Where it's running

• Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District
  Shanghai, Shanghai, China Recruiting
• Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area
  Shanghai, Shanghai, China Recruiting

Study contacts

• Principal investigator: Xiaohua Wu, MD, Ph.D — Fudan University
• Study coordinator: Xiaohua Wu, MD, Ph.D
• Email: docwxh@hotmail.com
• Phone: 021-64175590-82900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.