About this trial
A multicenter, open label, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 injection for HPV18 positive solid tumor. The study will investigate RP2D of HRYZ-T101 TCR-T cell injection.
Eligibility criteria
Qualifiers
1. The patient must be willing to sign the informed consent form.
2. Age ≥18 years and ≤75 years.
3. Metastatic or recurrent solid tumors with confirmed HPV18 infection based on TNM & FIGO staged histopathological investigation. .
4. Subjects who have failed anti-tumor treatment in the past and lack effective treatment options.
Disqualifiers
1. 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.
2. Those who have undergone systemic anti-tumor treatment within 4 weeks before apheresis, including who have received conventional chemotherapy, large-area radiotherapy, targeted therapy, immunotherapy or biological therapy, and other anti-tumor treatment. Have received small molecule targeted drugs and oral fluorouracils or Chinese herbal medicine within 2 weeks before apheresis.
3. Have received any investigational drug within 4 weeks before apheresis, or have participated in another clinical study at the same time.
4. Have received any cell therapy products before.
Trial design
Treatments tested in this trial
- HRYZ-T101 Injection
- Fludarabine + Cyclophosphamide