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

NCT07371624 | Recruiting Phase 1

• 1 other identifier: TSL-BM-B2065-I/IIa
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (5)

• Incidence of participants with dose-limiting toxicity

  Tolerability assessment (Phase l dose-escalation stage only). Dose-limiting toxicity (DLT) was defined as Grade ≥3 adverse events related to B2065 occurring within 28 days after dosing, assessed according to CTCAE (v6.0).

  Within 28 days after dosing.

• Infusion reactions

  Infusion-related reactions include hypersensitivity reactions and systemic complications.

  Within 7 days, 14 days, and 28 days.

• All-cause mortality

  Within 14 days,12 months, and 24 months.

• Tumorigenicity surveillance

  Tumorigenicity assessments included chest and abdominal CT scans and tumor markers, including alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA125), carbohydrate antigen 19-9 (CA199), squamous cell carcinoma antigen (SCCA), prostate-specific antigen (PSA), and neuron-specific enolase (NSE). Additional tumor markers assessed in female participants included carbohydrate antigen 15-3 (CA15-3), human chorionic gonadotropin (hCG), serum ferritin (SF), and beta-2 microglobulin (β2-MG).

  Month 6 and month 24.

• Adverse events (AEs)

  Occurrence rate of AEs.

  Day1 to month 24.

Secondary Outcomes (6)

• Proportion of participants with an modified Rankin Scale score of 0-2 after treatment

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

• Proportion of participants with an modified Rankin Scale score of 0-1 after treatment

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

• Proportion of participants with a decrease in NIH Stroke Scale score of ≥4 points from baseline or an NIHSS score ≤1 after treatment

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

• Change from baseline in NIH Stroke Scale score after treatment

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

• Proportion of participants with a Barthel Index score of 95-100 after treatment

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

Other Outcomes (3)

• Immune Biomarkers [Exploratory Outcome 1]

  Pre-dose (within 20 minutes prior to dosing) and Day 3, Day 28, and Day 90 post-dose.

• Nerve Growth Factor [Exploratory Outcome 2]

  Pre-dose (within 20 minutes prior to dosing) and Day 7, Day 28, Day 90, and Month 12 post-dose.

• Anti-drug Antibodies [Exploratory Outcome 3]

  Pre-dose (within 20 minutes prior to dosing) and Day 14, Day 28, Day 90, and Month 12 post-dose.

Study Arms (2)

B2065

EXPERIMENTAL

Phase I dose escalation includes 5.0×10\^7 cells (1 bag), 1.5×10\^8 cells (3 bags), and 4.5×10\^8 cells (9 bags), formulated in 1% human serum albumin and sodium chloride injection. Phase IIa dose expansion will select 1-2 dose cohorts from Phase I. Participants will be randomized in a 2:1 ratio (B2065:placebo).

Drug: B2065

Placebo

PLACEBO COMPARATOR

Placebo (1% human serum albumin in sodium chloride injection) administered by intravenous infusion, with matched volume and number of bags.

Drug: Placebo

Interventions

B2065 DRUG

Administered by intravenous infusion.

B2065

Placebo DRUG

Administered by intravenous infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The patient or legally authorized representative is willing to participate in this trial and agrees to sign the informed consent form.

You may not qualify if:

• 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.
• Patients with decreased level of consciousness (NIHSS item 1a score ≥2).
• Patients who may have major neurologic or psychiatric disorders that seriously interfere with the participant's compliance with trial assessments.
• Body temperature \>38°C prior to dosing, and the investigator assesses that there is a risk of infection.
• Patients with uncontrollable active infection; or patients who have received systemic anti-infective therapy within 7 days prior to dosing and, in the investigator's judgment, may be likely to convert to uncontrollable active infection in the short term.
• Patients with current or prior severe diseases of other organ systems, including but not limited to:
• Patients with severe heart failure (NYHA Class III or IV) and/or severe respiratory failure;
• Patients with renal disease with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²;
• Advanced liver disease, such as hepatitis or liver cirrhosis;
• Patients positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); patients positive for hepatitis B e antibody (HBeAb) and/or hepatitis B core antibody (HBcAb) with quantitative HBV-DNA above the upper limit of normal; patients with any of the following test results positive: hepatitis C virus antibody (HCV-Ab), Treponema pallidum antibody (TP-Ab), or human immunodeficiency virus antibody (HIV-Ab);
• Patients with hypertension not controlled after taking therapeutic medications, with systolic blood pressure ≥185 mmHg and/or diastolic blood pressure ≥110 mmHg;
• Blood glucose \<2.8 mmol/L (50 mg/dL) or \>22.2 mmol/L (400 mg/dL).

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 28, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

CN (1)