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A Study of B2065 in Patients With Acute Ischemic Stroke

StatusRecruiting
PhasePhase 1/2
Started2025-12-31
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 5 → 6 primary endpoints
See other at-risk trials from Tasly Pharmaceutical Group Co., Ltd

Amendment history

2026-08-11
Study Identification, Study Status, Study Description, Outcome Measures v1
Primary endpoint(s) modified5 to 6 entries
WasAdverse events (AEs), All-cause mortality, Incidence of participants with dose-limiting toxicity, Infusion reactions, Tumorigenicity surveillance
NowAll-Cause Mortality Rate [Safety], Change from baseline in serum tumor marker levels [Safety], Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) [Safety], Incidence of Dose-Limiting Toxicities (DLTs) [Safety], Incidence of Infusion-Related Reactions [Safety], Incidence of abnormal imaging findings indicative of tumorigenicity [Safety]
Secondary endpoints6 entries, revised
Proportion of participants withachieving ana modified Rankin Scale (mRS) score of 0-2 after[Efficacy] Proportion treatmentof participants achieving a modified Rankin Scale (mRS) score of 0-1 [Efficacy] Proportion of participants with anneurological modifiedimprovement Rankinbased Scale score of 0-1 after treatment Proportion of participants with a decrease inon NIH Stroke Scale score(NIHSS) of ≥4 points from baseline or an NIHSS score ≤1 after treatment[Efficacy] Change from baseline in NIH Stroke Scale (NIHSS) score after treatment[Efficacy] Proportion of participants withachieving a Barthel [...] [...]
Study title-54 characters
A Study of the Safety, Tolerability and Preliminary Efficacy of B2065 in Patients With Acute Ischemic Stroke.
2026-01-19
Original filing
The goal of this clinical trial is to evaluate the safety of B2065, an allogeneic adipose-derived mesenchymal stromal cell (AD-MSC) injection. It will also assess whether B2065 works to treat acute ischemic stroke. The main questions it aims to answer are: At what dose range is the drug safe for participants? Which dose shows preliminary efficacy? Researchers will compare B2065 to a placebo (a look-alike substance that contains no drug) to see if B2065 works to treat acute ischemic stroke. Participants will: Receive a single dose of B2065 during hospitalization Visit the hospital as scheduled for safety and efficacy assessments
Trial Details
NCT Number NCT07371624
Lead Sponsor Tasly Pharmaceutical Group Co., Ltd
Conditions Acute Ischemic Stroke
Enrollment 54 participants
Start Date 2025-12-31
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-13