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

NCT07655453 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Autoimmune Diseases

Interventions

DRUG

STR-P005

Dose escalation follows the traditional "3+3" design, with multiple, multi-cycle intravenous infusions

Sponsors & Collaborators

  • Starna Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-07-30
Completion
2028-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07655453 on ClinicalTrials.gov