DB-3Q for the Treatment of Medically Refractory Crohn's Disease

NCT07625293 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 3Q-CD-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying DB-3Q as a possible treatment for medically refractory Crohn's disease. The purpose of this study is to research and evaluate safety and effectiveness of the administration of bone marrow mesenchymal stem cell (bmMSC) derived extracellular vesicles product, DB-3Q, the study drug for Crohn's disease.

Conditions

Crohn Disease (CD)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in SES-CD Score

  Simple Endoscopic Score for Crohn's Disease (SES-CD) is a standardized tool used by gastroenterologists to assess and quantify the severity of Crohn's disease during an endoscopy or colonoscopy. The scale goes from 0 to greater than 15, with a lower score being better.

  12 Weeks

Study Arms (4)

DB-3Q 15 mL IV

EXPERIMENTAL

Biological: DB-3Q

DB-3Q 30 mL IV

EXPERIMENTAL

Biological: DB-3Q

DB-3Q 45 mL IV

EXPERIMENTAL

Biological: DB-3Q

Placebo IV

PLACEBO COMPARATOR

Other: Placebo

Interventions

DB-3Q BIOLOGICAL

bmMSC derived, extracellular vesicle enriched secretome product

DB-3Q 15 mL IV; DB-3Q 30 mL IV; DB-3Q 45 mL IV

Placebo OTHER

0.9% Saline

Placebo IV

Eligibility Criteria

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

You may qualify if:

• Written informed consent from participant
• Males and females 18-75 years of age
• Diagnosed with Crohn's disease of at least 6 months duration with medically refractory symptoms that failed to respond or responded but recurred after one advanced immunologic therapy (must have been receiving at least one advanced immunological therapy for 14 weeks duration prior to screening, including, but not limited to, adalimumab, certolizumab, , infliximab, risankizumab, upadacitinib, ustekinumab and vedolizumab), or is intolerant, or has a contraindication to advanced immunological therapy with a next step of subtotal colectomy or escalation in medical management
• Active CD as defined by a CDAI score ≥ 220 and/or SES-CD score ≥ 4
• Exposure to corticosteroids, 5-aminosalicylic acid (5-ASA) drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin and anti-interleukin in the past are permitted but a washout period of 8 weeks for any monoclonal antibody is necessary
• If receiving conventional immunomodulators (i.e., azathioprine \[AZA\], mercaptopurine \[6-MP\], or methotrexate \[MTX\]), must have been taking them for ≥12 weeks, and on a stable dose for at least 4 weeks prior to initial administration of IMP
• If AZA, 6-MP, or MTX has been recently discontinued, it must have been stopped for at least 4 weeks prior to initial administration of IMP
• If receiving oral 5-ASA compounds, the dose must have been stable for at least 4 weeks. If receiving oral corticosteroids, the dose must be ≤20 mg/day prednisone or its equivalent and must have been stable for at least 4 weeks prior to initial administration of IMP
• If receiving budesonide, the dose must have been stable for at least 2 weeks prior to initial administration of IMP
• If oral 5-ASA compounds or oral corticosteroids (including budesonide) have been recently discontinued, they must have been stopped for at least 2 weeks prior to initial administration of IMP
• The following medications/therapies must have been discontinued before initial administration of IMP:
• Monoclonal therapy (e.g., adalimumab, certolizumab, infliximab, risankizumab, ustenkinumab, and vedolizumab) for at least 8 weeks
• Cyclosporine, tacrolimus, or sirolimus, for at least 4 weeks
• thioguanine (6-TG) must have been discontinued for at least 4 weeks
• JAK inhibitors (e.g., upadacitinib) must have been discontinued for at least 4 weeks

You may not qualify if:

• Lack of informed consent
• Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
• Clinically significant medical conditions within the six months before initial administration of IMP: e.g., myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the participant
• Confirmed Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C infections
• Aspartate aminotransferase (AST) or Alanine transaminase (ALT) greater than 3 times the upper limit of normal at screening
• Abnormal basic laboratory values with the following cut-offs:
• Alkaline phosphate \> 200 U/L
• WBC \>13 109/L
• Hemoglobin \< 7 g/dL
• Platelets \< 50 or \> 109/L
• eGFR \< 60 mL/min/1.73m2
• HbA1C \> 8%
• Prothrombin time (PT), partial thromboplastin time (aPTT) or international normalized ratio (INR) greater than 1.5 times the upper limits of normal at screening
• Clinically significant abnormal vital signs prior to initial administration of IMP as defined by:
• Systolic blood pressure \>160 or \<90 mmHg

Sponsors & Collaborators

• Direct Biologics, LLC: lead

Study Sites (1)

Washington University, St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Central Study Contacts

Bill Arana

CONTACT

15123547124; barana@directbiologics.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)