Last updated: July 26, 2022
Sponsor: Fudan University
Overall Status: Active - Recruiting
Phase
1
Condition
Vaginal Cancer
Dysfunctional Uterine Bleeding
Cervical Cancer
Treatment
N/AClinical Study ID
NCT05475847
1031-031
Ages 18-70 Female
Study Summary
Eligibility Criteria
Inclusion
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 metastaticcervical cancer who failed the standard treatment.
- Has access to tumor tissue and can isolate ≥1.0g of tumor tissue mass for thepreparation 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 atscreening
Exclusion
Exclusion Criteria:
- Uncontrolled CNS disease, severe cerebrovascular disease or obvious neurologicalsymptoms (including mental disease)
- Symptomic chronic obstructive pulmonary disease or persistent asthma
- Uncontrolled cardiovascular diseases
- History of primary immune deficiency, autoimmune disease or chronic inflammatorydisease
- 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 interferewith the study results
Study Design
Total Participants: 20
Study Start date:
July 01, 2022
Estimated Completion Date:
July 31, 2025
Study Description
Connect with a study center
Fudan University Shanghai Cancer Center, No. 270, Dong'an Road, Xuhui District
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Fudan University Shanghai Cancer Center, No. 4333, Kangxin Road, Pudong New Area
Shanghai, Shanghai 201315
ChinaActive - Recruiting

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