drugset
drugset / Trial / NCT07371624

A Study of the Safety, Tolerability and Preliminary Efficacy of B2065 in Patients With Acute Ischemic Stroke.

NCT07371624 ↗

Phase 1/2 Recruiting 54 enrolled Tasly Pharmaceutical Group Co., Ltd
RandomizedParallel-groupDouble-blindTreatment

Summary

This Phase I/IIa, randomized, double-blind, placebo-controlled study evaluates the safety, tolerability, and preliminary efficacy of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection, in patients with acute ischemic stroke. Participants receive a single intravenous infusion of B2065 or placebo within 36 hours of stroke symptom onset. Phase I uses dose escalation with sentinel dosing to assess dose-limiting toxicities within 28 days and to inform dose selection. Phase IIa expands 1-2 selected dose level(s) and randomizes participants 2:1 (B2065:placebo). Safety and functional outcomes are assessed through 24 months.

Timeline

Start
2025-12-31
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject B2065 Cell therapy 5e+07 cells Intravenous
Subject B2065 Cell therapy 1.5e+08 cells Intravenous
Subject B2065 Cell therapy 4.5e+08 cells Intravenous

Indications

ischemic stroke