A Study of B2065 in Patients With Acute Ischemic Stroke

ConditionAcute Ischemic Stroke

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years (inclusive of the boundary values), with no restriction on sex.

Patients with ischemic stroke confirmed by imaging examinations (CT/MRI).

Time from onset of stroke symptoms to administration of the investigational product ≤36 hours; for wake-up stroke, the time of onset is defined as the last-known-well time (the last time the patient was observed to be normal).

NIHSS score at screening is 8 to 20.

Disqualifiers

Patients who have received intravenous thrombolysis and/or mechanical thrombectomy prior to dosing.

Modified Rankin Scale (mRS) score ≥2 before stroke onset.

Patients who currently have intracranial hemorrhagic diseases (e.g., intracerebral hemorrhage, epidural hematoma, subarachnoid hemorrhage, etc.), or who have brain tumors, cerebrovascular malformations, multiple sclerosis, a history of severe traumatic brain injury, encephalitis, or other conditions causing stroke-like symptoms.

Patients who are unable to undergo CT and/or MRI examinations.

Trial design

Design model

Parallel

Treatments tested in this trial

B2065
Drug
Administered by intravenous infusion.
Placebo
Drug
Administered by intravenous infusion.

Treatment groups

54 Participants

are divided into 2 treatment groups

Group A: B2065Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Incidence of Dose-Limiting Toxicities (DLTs) [Safety]

Percentage of participants experiencing DLTs during the Phase 1 dose-escalation stage.

Time frame

Within 28 days after dosing.

Incidence of Infusion-Related Reactions [Safety]

Percentage of participants experiencing infusion-related reactions, including hypersensitivity reactions and systemic complications.

Time frame

Within 7 days, 14 days, and 28 days.

All-Cause Mortality Rate [Safety]

Proportion of participants who die from any cause during the study period.

Time frame

Within 14 days,12 months, and 24 months.

Incidence of abnormal imaging findings indicative of tumorigenicity [Safety]

Percentage of participants with newly detected tumorous lesions as assessed by chest and abdominal CT scans.

Time frame

Month 6 and month 24.

Secondary outcomes

Proportion of participants achieving a modified Rankin Scale (mRS) score of 0-2 [Efficacy]

Percentage of participants achieving functional independence (mRS score 0-2). The mRS is a 7-level scale ranging from 0 (no symptoms) to 6 (death).

Time frame

Day 28, day 90, month 6, and month 12.

Proportion of participants achieving a modified Rankin Scale (mRS) score of 0-1 [Efficacy]

Percentage of participants achieving a favorable clinical outcome (mRS score 0-1).

Time frame

Day 28, day 90, month 6, and month 12.

Proportion of participants with neurological improvement based on NIH Stroke Scale (NIHSS) [Efficacy]

Percentage of participants with a decrease in NIHSS score of ≥4 points from baseline, or achieving an absolute NIHSS score ≤1.

Time frame

24 hours, day 3, day 7, day 14, and month 12.

Change from baseline in NIH Stroke Scale (NIHSS) score [Efficacy]

Quantitative assessment of neurological deficit changes from baseline. Scores range from 0 (no deficit) to 42 (severe deficit).

Time frame

24 hours, day 3, day 7, day 14, and month 12.

Other outcomes

Change from baseline in serum Immunoglobulin levels (IgG, IgM, IgA, IgE) [Exploratory]

Evaluation of humoral immune function changes post-dose.

Time frame

Change from baseline at Day 3, Day 28, and Day 90 post-dose.

Change from baseline in Regulatory T cells (Treg) percentage [Exploratory]

Assessment of immune regulation response.

Time frame

Change from baseline at Day 3, Day 28, and Day 90 post-dose.

Change from baseline in serum Tumor Necrosis Factor-alpha (TNF-α) concentration [Exploratory]

Assessment of systemic inflammatory response post-dose.

Time frame

Change from baseline at Day 3, Day 28, and Day 90 post-dose.

Change from baseline in serum Nerve Growth Factor (NGF) concentration [Exploratory]

Quantitative assessment of neurotrophic factor levels post-dose.

Time frame

Pre-dose and Day 7, Day 28, Day 90, and Month 12 post-dose.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tasly Pharmaceutical Group Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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