UnknownPhase 1

Study of C-TIL052A Cell Therapy in Advanced Cervical Cancer

China20 participantsStarted 2022-07

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexFEMALE

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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

What they're measuring

Adverse Events (AE)

Timeframe: up to 12 months or through study completion

Trial details

NCT IDNCT05475847

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07

Contact for this trial

Xiaohua Wu, MD, Ph.D

021-64175590-82900 docwxh@hotmail.com

View on ClinicalTrials.gov More Cervical Cancer trials