Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

Last updated: July 26, 2022
Sponsor: Fudan University
Overall Status: Active - Recruiting

Phase

1

Condition

Vaginal Cancer

Dysfunctional Uterine Bleeding

Cervical Cancer

Treatment

N/A

Clinical Study ID

NCT05475847
1031-031
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 metastaticcervical cancer who failed the standard treatment.
  4. Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for thepreparation 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 atscreening

Exclusion

Exclusion Criteria:

  1. Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurologicalsymptoms (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 inflammatorydisease
  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 interferewith the study results

Study Design

Total Participants: 20
Study Start date:
July 01, 2022
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area

    Shanghai, Shanghai 201315
    China

    Active - Recruiting

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