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Cervical CancerPhase 1NCT05952947

HRYZ-T101 Injection for HPV18 Positive Solid Tumor

A Phase 1 study testing HRYZ-T101 Injection and Fludarabine + Cyclophosphamide in people with Cervical Cancer and Head and Neck Squamous Cell Carcinoma, run by HRYZ Biotech Co. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
HRYZ-T101 Injection and Fludarabine + Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
1 Nov 2023to Feb 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 5. HPV18 positive and HLA-DRB1*0901 allele.
  • 6. ECOG performance status ≤1.
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  • 7. Estimated life expectancy ≥ 3 months.
  • 8. Patients must have at least one measurable lesion defined by RECIST 1.1.
  • 9. Patients with any organ dysfunction as defined below:
  • Leukocytes≥3.0 x 10^9/L;
  • blood platelets ≥75 x 10^9/L;
  • hemoglobin≥85g/L;
  • Absolute lymphocyte count≥0.8 x 10^9/L
  • Serum albumin ≥ 30g/L;
  • total bilirubin≤1.5×ULN; ALT/AST≤3×ULN or ≤5×ULN for liver metastases;
  • Creatinine clearance ≥50mL/min; or serum creatinine ≤1.5×ULN;
  • INR≤1.5×ULN; APTT≤1.5×ULN;
  • LVEF≥50%;
  • SpO2≥92%.
  • 10. Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 1 year after receiving HRYZ-T101 cell transfusion treatment. HCG test for female with potential fertility must be negative within 7 days before apheresis.

Who cannot join

  • 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.
  • 5. Those who have undergone major surgery within 4 weeks before apheresis, or minor surgery within 2 weeks before apheresis.
  • 6. Toxicity of previous treatment has not been mitigated or ≤ Grade 1 before apheresis.
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  • 7. Have received live attenuated vaccine or adenovirus vector vaccine within 4 weeks before apheresis.
  • 8. Have central nervous system metastasis with symptoms.
  • 9. Subjects with clinical cardiac symptoms or diseases that cannot be well controlled.
  • 10. Subjects with serious or uncontrolled systemic disease or any unstable systemic disease.
  • 11. Subjects with active infection requiring systemic treatment with anti-infective drugs within 2 weeks before apheresis.
  • 12. Subjects have any active autoimmune disease or history of autoimmune disease.
  • 13. Have received immunosuppressive agents, or systemic corticosteroids, immunomodulators within 2 weeks before apheresis.
  • 14. Subjects with other malignant tumors. Except for: (1) Carcinoma in situ with curative treatment and no evidence of recurrence for at least 2 years; (2) the primary malignant tumor has been completely resected and achieved CR for ≥ 2 years.
  • 15. Subjects with history of thromboembolism ≥ Grade 3 within 6 months before apheresis, or is receiving thrombolytic or anticoagulant for high-risk of thromboembolism.
  • 16. Known HIV or syphilis infection, and/or active hepatitis B virus or hepatitis C virus infection.
  • 17. Organ transplanters and allogeneic cell transplanters.
  • 18. Subjects with active pulmonary tuberculosis infection within 1 year or have not received treatment at least 1 year before apheresis.
  • 19. Pregnant or lactating female, or those whose HCG test is positive before enrollment.
  • 20. According to the judgment of the researcher, those who are not suitable for the group, such as poor compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xuemin Rao contact

021-61049928

raoxuemin@shhryz.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Xuemin Rao, raoxuemin@shhryz.com

    Jian Zhang, Doctor

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Single Arm, Open Label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HRYZ-T101 Injection for HPV18 Positive Solid Tumor

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.

Being tested
HRYZ-T101 Injection, Fludarabine + Cyclophosphamide
Medical subject headings
Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck, Vaginal Neoplasms, Penile Neoplasms, Anus Neoplasms, Vulvar Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRYZ-T101 InjectionBiological

    On day 1, the TCR-T cells will be administered intravenously.

  • Fludarabine + CyclophosphamideDrug

    Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days

Study groups in NCT05952947
Study groupRoleWhat they receive
HRYZ-T101 InjectionExperimentalPatients will undergo lymphocytapheresis, then treatment with HRYZ-T101 TCR-T cells.
Receives: Biological: HRYZ-T101 Injection; Drug: Fludarabine + Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Dose-limiting toxicity

    Measured: 28 days

  2. Adverse events and serious adverse events

    Incidence of adverse events and serious adverse events

    Measured: 2 years

Secondary outcomes (8)

  1. Objective Response Rate（ORR）

    The percentage of subjects with PR or CR assessed by RECIST 1.1.

    Measured: 2 years

  2. Disease Control Rate (DCR)

    The percentage of subjects with a confirmed CR, PR, or stable disease (SD) assessed by RECIST 1.1.

    Measured: 2 years

  3. Duration of response (DoR)

    Subjects who show a confirmed CR or PR as assessed by RECIST 1.1.

    Measured: 2 years

  4. Time to response (TTR)

    Time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by RECIST 1.1.

    Measured: 2 years

  5. Progression-Free Survival（PFS）

    The length of time from enrollment until the time of progression of disease.

    Measured: 2 years

  6. Overall Survival (OS)

    The interval of time between the date of T-cell infusion and the date of death.

    Measured: 2 years

  7. Duration of TCR T cells in-vivo persistence

    Blood samples were collected to measure persistence of infused HRYZ-T101.

    Measured: 2 years

  8. Concentration of Cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ)

    Collect blood samples and analyze for presence of cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ) at specified intervals before and after treatment with HRYZ-T101.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2023
  2. Study start1 Nov 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05952947
Sponsor's protocol ID
H-T01-C2001
Status last verified
Jun 2023
First submitted
5 Jul 2023
Last updated
2 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HRYZ-T101 Injection and Fludarabine + Cyclophosphamide in people with Cervical Cancer and Head and Neck Squamous Cell Carcinoma, run by HRYZ Biotech Co. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xuemin Rao (021-61049928, raoxuemin@shhryz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05952947.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024; AzTrials last refreshed its copy on 30 Oct 2026.

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