Treatment of Advanced Solid Tumors With TSA-CTL(Tumor Specific Antigen-Induced Cytotoxic T Lympho… (NCT02959905) | Clinical Trial Compass
CompletedPhase 1
Treatment of Advanced Solid Tumors With TSA-CTL(Tumor Specific Antigen-Induced Cytotoxic T Lymphocytes)
China11 participantsStarted 2016-12-22
Plain-language summary
The primary objective of this study is to evaluate the safety of TSA-CTL in the treatment of advanced solid tumors.
The secondary objective of this study is to evaluate preliminarily the effect of TSA-CTL in the treatment of advanced solid tumors.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Greater than or equal to 18 years of age and less than or equal to 70 years of age; all genders.
✓. Advanced solid tumors including but not limited to some high frequency somatic mutations, such as melanoma, colorectal cancer, gastric cancer, esophageal cancer, squamous cell carcinoma of the lung, triple-negative breast cancer, etc.
✓. Advanced solid tumors patients who are HLA - A0201 /A1101/A2402 subtypes.
✓. Measurable solid tumors with at least one lesion that is resectable or tumor biopsies for DNA extraction.
✓. Patients who failed or were intolerant to standard treatment.
✓. Patients (or their legal representatives) who are able to understand and sign the Informed Consent Form and willing to sign a durable power of attorney.
✓. Clinical performance status of ECOG is 0 or 1 and expected lifetime is greater than six month and patients who are able to cooperate to observe adverse reactions and the effect of the treatment.
✓. Patients of both genders must be willing to practice birth control from the time of enrollment to five months after treatment on this study.
Exclusion criteria
✕. Pregnant or lactating women.
✕. Any primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
✕. Opportunistic infection.
What they're measuring
1
Number of participants with adverse events as assessed by CTCAE v5.0.