NCT05787535RecruitingPhase 1
A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of HRYZ-T101 TCR-T Cell for HPV18 Positive Advanced Solid Tumor
HRYZ Biotech Co.1 site in 1 country17 target enrollmentStarted: March 21, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- DLT
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •Estimated life expectancy ≥ 3 months.
- •Patients must have at least one measurable lesion defined by RECIST 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%.
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.
- •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.
- •Other serious organic diseases and mental disorders.
- •Have received any gene therapy products before.
- •According to the judgment of the researcher, those who are not suitable for the group, such as poor compliance.
Arms & Interventions
HRYZ-T101 TCR-T cell therapy
Experimental
Patients will undergo lymphocytapheresis, then treatment with TCR-T cell.
Intervention: HRYZ-T101 TCR-T Cell (Biological)
HRYZ-T101 TCR-T cell therapy
Experimental
Patients will undergo lymphocytapheresis, then treatment with TCR-T cell.
Intervention: Fludarabine + Cyclophosphamide (Drug)
Outcomes
Primary Outcomes
DLT
Time Frame: 28 days
Dose-limiting toxicity
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).
Time Frame: 2 years
Assessed by CTCAE V5.0
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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