Actively Recruiting
HRYZ-T101 Injection for HPV18 Positive Solid Tumor
Led by HRYZ Biotech Co. · Updated on 2024-02-02
32
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HRYZ-T101 Injection for HPV18 Positive Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to sign the informed consent form
- Age 18 to 75 years
- Metastatic or recurrent solid tumors confirmed positive for HPV18 by histopathology
- Previous anti-tumor treatments failed and no effective options available
- Presence of HLA-DRB1*0901 allele
- ECOG performance status 0 or 1
- Estimated life expectancy of at least 3 months
- At least one measurable lesion by RECIST 1.1 criteria
- Adequate organ function as defined by blood counts, liver and kidney tests, heart function, and oxygen saturation
- Agreement to use effective contraception during the study and for 1 year after treatment if of potential fertility
- Negative HCG test within 7 days before apheresis for females of potential fertility
You will not qualify if you...
- History of allergy to cyclophosphamide, fludarabine, or any treatment ingredient
- Systemic anti-tumor treatment within 4 weeks before apheresis, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biological therapy
- Use of small molecule targeted drugs, oral fluorouracils, or Chinese herbal medicine within 2 weeks before apheresis
- Participation in another clinical study or investigational drug use within 4 weeks before apheresis
- Previous cell therapy product receipt
- Major surgery within 4 weeks or minor surgery within 2 weeks before apheresis
- Ongoing toxicity from previous treatments above Grade 1
- Live attenuated or adenovirus vector vaccine within 4 weeks before apheresis
- Symptomatic central nervous system metastasis
- Uncontrolled cardiac symptoms or diseases
- Serious or uncontrolled systemic or unstable diseases
- Active infection requiring systemic anti-infective treatment within 2 weeks before apheresis
- Active or history of autoimmune disease
- Use of immunosuppressive agents, corticosteroids, or immunomodulators within 2 weeks before apheresis
- Other malignant tumors except carcinoma in situ cured for at least 2 years or primary tumor resected with complete remission for at least 2 years
- Grade 3 or higher thromboembolism within 6 months or ongoing anticoagulant therapy for high risk
- Known HIV, syphilis, or active hepatitis B or C infection
- Organ or allogeneic cell transplant recipients
- Active pulmonary tuberculosis within 1 year or untreated in the past year
- Pregnant or breastfeeding women or positive HCG test before enrollment
- Any condition judged by investigators as unsuitable for participation such as poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
X
Xuemin Rao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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