Early Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of STR-P005

Summary

This study is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in subjects with relapsed/refractory autoimmune diseases. The study will employ the traditional "3+3" dose escalation model, setting up 3 dose groups: Amg/kg, Bmg/kg, C mg/kg. Dose Group 1 will serve as the starting dose, with two cohorts A and B within this group aimed at optimizing the dosing frequency of STR-P005. Cohort A will receive dosing every 3 days (Q3D), on D1, D4, D7 (3 doses) constituting one cycle, which can be repeated for 2 cycles. Cohort B will receive dosing every 4 days (Q4D), on D1, D4 (2 doses) constituting one cycle, which can be repeated for 2 cycles. Based on the preliminary safety data, efficacy information, and PK/PD parameters obtained from Cohorts 1A and 1B, the investigators will select the superior regimen and escalate sequentially to Dose Groups 2 and 3. If no MTD is found after dose escalation through the 3 groups, based on all available preliminary safety data, efficacy information, and PK/PD parameters, higher doses may be added for further exploration of safety and efficacy after discussion by the SRC.

Timeline

Start

2026-08-01

Primary completion

2027-07-30

Completion

2028-07-30

Drugs

Indications

No indication recorded.