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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

• 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.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xuemin Rao
raoxuemin@shhryz.com
021-61049928
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2028-02
Participants
Target number of participants: 32
Treatments
Experimental: HRYZ-T101 Injection
Patients will undergo lymphocytapheresis, then treatment with HRYZ-T101 TCR-T cells.
Sponsors
Leads: HRYZ Biotech Co.

This content was sourced from clinicaltrials.gov

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