HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor
China17 participantsStarted 2023-03-21
Plain-language summary
A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 TCR-T cell for HPV18 positive advanced solid tumor. The study will investigate DLT of HRYZ-T101 TCR-T cell injection.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. The patient must be willing to sign the informed consent form.
✓. Age ≥18 years and ≤70 years.
✓. Histologically-confirmed advanced metastatic or recurrent solid tumors with confirmed HPV18 infection and HLA-DRB1\*09:01 allele.
✓. Subjects who have failed at least first-line treatment in the past and lack effective treatment options.
✓. ECOG performance status of 0-1.
✓. Estimated life expectancy ≥ 3 months.
✓. Patients must have at least one measurable lesion defined by RECIST 1.1.
✓. Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 6 months after receiving HRYZ-T101 cell transfusion treatment.
Exclusion criteria
✕. Organ transplanters and allogeneic cell transplanters.
✕. Have a history of hypersensitivity to cyclophosphamide or fludarabine, and it is known that any ingredient used in the treatment of this study will produce allergic reactions.
✕. Those who have undergone major surgery within 4 weeks before enrollment, and those who have received conventional chemotherapy, large-area radiotherapy, targeted therapy, endocrine therapy, immunotherapy or biological therapy, and Chinese herbal medicine and other anti-tumor treatment.
What they're measuring
1
DLT
Timeframe: 28 days
2
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).