Cervical CancerPhase 1NCT05787535
HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor
A Phase 1 study testing Fludarabine + Cyclophosphamide and HRYZ-T101 TCR-T Cell in people with Cervical Cancer and Head and Neck Squamous Cell Carcinoma, run by HRYZ Biotech Co. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Oropharyngeal Cancer
- What is being tested?
- Fludarabine + Cyclophosphamide and HRYZ-T101 TCR-T Cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 21 Mar 2023to Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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%.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Shuang Hao contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200120
Shuang Hao, haoshuang@shhryz.com
Jian Zhang, Doctor
About this study
Official title: 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.
- Conditions
- Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Oropharyngeal Cancer, Vagina Tumor, Carcinoma of Penis, Anal Carcinoma
- Being tested
- Fludarabine + Cyclophosphamide, HRYZ-T101 TCR-T Cell
- Medical subject headings
- Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms, 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.
Fludarabine + CyclophosphamideDrug
Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days
HRYZ-T101 TCR-T CellBiological
On day 1, the TCR-T cells will be administered one time.
| Study group | Role | What they receive |
|---|---|---|
| HRYZ-T101 TCR-T cell therapy | Experimental | Patients will undergo lymphocytapheresis, then treatment with TCR-T cell. Receives: Drug: Fludarabine + Cyclophosphamide; Biological: HRYZ-T101 TCR-T Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-limiting toxicity
Measured: 28 days
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).
Assessed by CTCAE V5.0
Measured: 2 years
Secondary outcomes (5)
Objective Response Rate（ORR）
The percentage of subjects with PR or CR assessed by RECIST 1.1.
Measured: 2 years
Overall Survival (OS)
From enrollment to death of patients.
Measured: 2 years
Duration of Response（DOR）
The length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.
Measured: 2 years
Progression-Free Survival（PFS）
The length of time from enrollment until the time of progression of disease.
Measured: 2 years
Duration of TCR T cells in-vivo persistence
Blood samples were collected to measure persistence of infused HRYZ-T101.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start21 Mar 2023
- Primary completionFeb 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HRYZ Biotech Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian Zhang, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787535
- Sponsor's protocol ID
- HRYZ-T101-1002
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of HRYZ-T101 TCR-T Cell for HPV18 Positive Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05787535
- Acronym / sponsor ID
- HRYZ-T101-1002
- Conditions
- Cervical Cancer, Head and Neck Squamous Cell Carcinoma, Oropharyngeal Cancer, Vagina Tumor, Carcinoma of Penis, Anal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- HRYZ Biotech Co.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRYZ-T101 TCR-T cell therapy | Experimental | Drug: Fludarabine + Cyclophosphamide, Biological: HRYZ-T101 TCR-T CellPatients will undergo lymphocytapheresis, then treatment with TCR-T cell. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fludarabine + CyclophosphamideFludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days | Drug | HRYZ-T101 TCR-T cell therapy |
| HRYZ-T101 TCR-T CellOn day 1, the TCR-T cells will be administered one time. | Biological | HRYZ-T101 TCR-T cell therapy |
Primary outcome
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
5 secondary outcomes
Objective Response Rate（ORR）
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Duration of Response（DOR）
Time frame: 2 years
Progression-Free Survival（PFS）
Time frame: 2 years
Duration of TCR T cells in-vivo persistence
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuang Hao contact
Jian Zhang, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fludarabine + Cyclophosphamide and HRYZ-T101 TCR-T Cell 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 10 inclusion and 18 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: status not confirmed, 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?
Results are not available in the source record.
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?
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.