Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer (TIL)

  • STATUS
    Recruiting
  • End date
    Jul 11, 2025
  • participants needed
    20
  • sponsor
    Fudan University
Updated on 11 August 2022
metastatic cervical cancer

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.

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.

Details
Condition Cervical Cancer
Treatment Autologous Tumor Infiltrating Lymphocytes (C-TIL052A) Injection
Clinical Study IdentifierNCT05475847
SponsorFudan University
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 to 70 years at screening
Voluntary participation and able to sign the informed consent form
Patients with histologically confirmed persistent, recurrent and/or metastatic cervical cancer who failed the standard treatment
Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for the preparation of autologous tumor infiltrating lymphocytes
At least one measurable target lesion (per RECIST v1.1)
ECOG performance status score: 0~1
Expected survival ≥ 3 months
Negative serum or urine pregnancy test results for females of child-bearing age at screening

Exclusion Criteria

Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurological symptoms (including mental disease)
Symptomic chronic obstructive pulmonary disease or persistent asthma
Uncontrolled cardiovascular diseases
History of primary immune deficiency, autoimmune disease or chronic inflammatory disease
High-risk subjects with rapid tumor progression as judged by the Investigator(s)
Complicated with infectious diseases, such as hepatitis B/C, syphilis, AIDS
History of organ transplantation or allogeneic cell therapy
Any situation judged by the Investigator(s) that will have safety concern or interfere with the study results
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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