HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor

January 31, 2024 updated by: HRYZ Biotech Co.

A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of HRYZ-T101 TCR-T Cell for HPV18 Positive Advanced Solid Tumor

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Jian Zhang, Doctor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The patient must be willing to sign the informed consent form.
  2. Age ≥18 years and ≤70 years.
  3. Histologically-confirmed advanced metastatic or recurrent solid tumors with confirmed HPV18 infection and HLA-DRB1*09:01 allele.
  4. Subjects who have failed at least first-line treatment in the past and lack effective treatment options.
  5. ECOG performance status of 0-1.
  6. Estimated life expectancy ≥ 3 months.
  7. Patients must have at least one measurable lesion defined by RECIST 1.1.
  8. 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.
  9. Patients with any organ dysfunction as defined below:

1) 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:

  1. Organ transplanters and allogeneic cell transplanters.
  2. 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.
  3. 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.
  4. Have received live attenuated vaccine within 4 weeks before enrollment.
  5. Subjects with clinical cardiac symptoms or diseases that cannot be well controlled.
  6. The subject has active infection or fever more than 38.5 degrees of unknown cause during screening and before cell transfusion.
  7. Subjects have any active autoimmune disease or history of autoimmune disease.
  8. Subjects with other malignant tumors.
  9. Patients with central nervous system metastasis.
  10. Active, uncontrolled bacterial or fungal infection requiring systemic treatment.
  11. Known HIV or syphilis infection, and/or active hepatitis B virus or hepatitis C virus infection.
  12. It is planned to use immunosuppressive agents, or systemic corticosteroids, immunomodulators.
  13. Have received any investigational drug within 4 weeks before enrollment, or have participated in another clinical study at the same time.
  14. Pregnant or lactating subjects, or those who are unwilling to contraception during the test.
  15. Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure.
  16. Other serious organic diseases and mental disorders.
  17. Have received any gene therapy products before.
  18. According to the judgment of the researcher, those who are not suitable for the group, such as poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HRYZ-T101 TCR-T cell therapy
Patients will undergo lymphocytapheresis, then treatment with TCR-T cell.
Drug: Fludarabine + Cyclophosphamide
Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days
Biological: HRYZ-T101 TCR-T Cell
On day 1, the TCR-T cells will be administered one time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: 28 days
Dose-limiting toxicity
28 days
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).
Time Frame: 2 years
Assessed by CTCAE V5.0
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate（ORR）
Time Frame: 2 years
The percentage of subjects with PR or CR assessed by RECIST 1.1.
2 years
Overall Survival (OS)
Time Frame: 2 years
From enrollment to death of patients.
2 years
Duration of Response（DOR）
Time Frame: 2 years
The length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.
2 years
Progression-Free Survival（PFS）
Time Frame: 2 years
The length of time from enrollment until the time of progression of disease.
2 years
Duration of TCR T cells in-vivo persistence
Time Frame: Up to 2 years
Blood samples were collected to measure persistence of infused HRYZ-T101.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HRYZ Biotech Co.

Investigators

  • Principal Investigator: Jian Zhang, Doctor, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRYZ-T101-1002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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