RecruitingPhase 1

HRYZ-T101 Injection for HPV18 Positive Solid Tumor

China32 participantsStarted 2023-11-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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;

What they're measuring

DLT

Timeframe: 28 days

Adverse events and serious adverse events

Timeframe: 2 years

Trial details

NCT IDNCT05952947

SponsorHRYZ Biotech Co.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Xuemin Rao

021-61049928 raoxuemin@shhryz.com

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