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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRYZ-T101 TCR-T cell therapy | Experimental | Patients will undergo lymphocytapheresis, then treatment with TCR-T cell. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fludarabine + Cyclophosphamide | Drug | Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | The percentage of subjects with PR or CR assessed by RECIST 1.1. | 2 years |
| Overall Survival (OS) | From enrollment to death of patients. |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuemin Rao | Contact | 021-61049928 | raoxuemin@shhryz.com | |
| Shuang Hao | Contact | haoshuang@shhryz.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang, Doctor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009959 | Oropharyngeal Neoplasms |
| D014625 | Vaginal Neoplasms |
| D010412 | Penile Neoplasms |
| D001005 | Anus Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| HRYZ-T101 TCR-T Cell | Biological | On day 1, the TCR-T cells will be administered one time. |
|
| 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. | 2 years |
| Progression-Free Survival(PFS) | The length of time from enrollment until the time of progression of disease. | 2 years |
| Duration of TCR T cells in-vivo persistence | Blood samples were collected to measure persistence of infused HRYZ-T101. | Up to 2 years |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014623 | Vaginal Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D010409 | Penile Diseases |
| D052801 | Male Urogenital Diseases |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D014845 | Vulvar Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |