HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor
A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of HRYZ-T101 TCR-T Cell for HPV18 Positive Advanced Solid Tumor
1 other identifier
interventional
17
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2023
CompletedStudy Start
First participant enrolled
March 21, 2023
CompletedFirst Posted
Study publicly available on registry
March 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedFebruary 2, 2024
March 1, 2023
1.9 years
March 14, 2023
January 31, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
DLT
Dose-limiting toxicity
28 days
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).
Assessed by CTCAE V5.0
2 years
Secondary Outcomes (5)
Objective Response Rate（ORR）
2 years
Overall Survival (OS)
2 years
Duration of Response（DOR）
2 years
Progression-Free Survival（PFS）
2 years
Duration of TCR T cells in-vivo persistence
Up to 2 years
Study Arms (1)
HRYZ-T101 TCR-T cell therapy
EXPERIMENTALPatients will undergo lymphocytapheresis, then treatment with TCR-T cell.
Interventions
Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days
On day 1, the TCR-T cells will be administered one time.
Eligibility Criteria
You may qualify if:
- 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.
- Patients with any organ dysfunction as defined below:
- \) Leukocytes≥3.0 x 10\^9/L; 2) absolute neutrophil count ≤1.5 x 10\^9/L; 3) blood platelets ≥75 x 10\^9/L; 4) hemoglobin≥90g/L; 5) Serum albumin ≥ 3.0g/dL; 6) total bilirubin≤1.5×ULN; ALT/AST≤2.5×ULN; 7) Creatinine clearance ≥50mL/min; 8) INR≤1.5×ULN; APTT≤1.5×ULN; 9) LVEF≥50%; 10) SpO2≥92%.
You may not qualify if:
- 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.
- Have received live attenuated vaccine within 4 weeks before enrollment.
- Subjects with clinical cardiac symptoms or diseases that cannot be well controlled.
- The subject has active infection or fever more than 38.5 degrees of unknown cause during screening and before cell transfusion.
- Subjects have any active autoimmune disease or history of autoimmune disease.
- Subjects with other malignant tumors.
- Patients with central nervous system metastasis.
- Active, uncontrolled bacterial or fungal infection requiring systemic treatment.
- Known HIV or syphilis infection, and/or active hepatitis B virus or hepatitis C virus infection.
- It is planned to use immunosuppressive agents, or systemic corticosteroids, immunomodulators.
- Have received any investigational drug within 4 weeks before enrollment, or have participated in another clinical study at the same time.
- Pregnant or lactating subjects, or those who are unwilling to contraception during the test.
- Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HRYZ Biotech Co.lead
Study Sites (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200120, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Zhang, Doctor
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2023
First Posted
March 28, 2023
Study Start
March 21, 2023
Primary Completion
February 1, 2025
Study Completion
September 1, 2025
Last Updated
February 2, 2024
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share