C-TIL052A cell therapy for 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

This study is testing a new cell therapy for people with advanced cervical cancer who haven't had success with other treatments to see if it can help fight their cancer safely.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Locations: 2 sites (Shanghai, Shanghai and 1 other locations)
• Trial ID: NCT05475847 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with histologically confirmed persistent, recurrent, or metastatic cervical cancer who have failed standard treatments.

Not a fit: Patients with uncontrolled CNS disease, severe cardiovascular issues, or significant autoimmune conditions may not benefit from this therapy.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced cervical cancer who have limited alternatives.

How similar studies have performed: Other studies using tumor infiltrating lymphocytes have shown promise in treating various cancers, suggesting potential for success in this novel application.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai and 1 other locations

• 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

Conditions Cervical Cancer; Gynecological tumor; Tumor Infiltrating Lymphocytes