Crohn Disease (CD)Phase 2NCT07625293
DB-3Q for the Treatment of Medically Refractory Crohn's Disease
A Phase 2 study testing DB-3Q in people with Crohn Disease (CD), run by Direct Biologics, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease (CD)
- What is being tested?
- DB-3Q
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- 6-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
- Rectal corticosteroids (i.e., corticosteroids [including budesonide] administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks
- Rectal 5-ASA compounds (i.e., 5-ASAs administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks
- Parenteral corticosteroids for at least 2 weeks
- Total parenteral nutrition for at least 2 weeks
- Antibiotics for the treatment of CD (e.g., ciprofloxacin, metronidazole, or rifaximin) for at least 2 weeks
- No colonic dysplasia and malignancy as ruled out by colonoscopy within 90 days prior to initial administration of IMP
- If participant is of reproductive capacity, willing to use adequate birth control measures while in the study
Who cannot join
- 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:
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- 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
- Diastolic blood pressure >90 or <60 mmHg
- Pulse <55 or >105 bpm
- Respiratory Rate (RR) <9 and >25 breaths per minute
- Temperature >100.4 degrees Fahrenheit
- SpO2 <92%
- History of cancer including melanoma (with the exception of localized skin cancers) within 5 years of study enrollment
- Ulcerative colitis or indeterminate colitis
- Suspicion or presence of an intraabdominal or perianal abscess
- Microscopic, ischemic or infectious colitis
- Neoplasia of the colon on preoperative biopsy
- Evidence of colonic perforation
- Colonic stricture that unable to pass an adult colonoscope
- Three or more prior small bowel resections
- Presence of an ostomy
- Massive hemorrhage from the colon requiring emergent surgery in the 6 months prior to screening
- Fulminant colitis requiring emergency surgery
- Concurrent active clostridium difficile infection of the colon
- Concurrent Cytomegalovirus infection of the colon via colonic biopsy with CMV stain taken within 90 days prior to screening
- Active or latent tuberculosis
- Unable to wean off corticosteroids
- Primary sclerosing cholangitis
- History of or current alcohol or drug abuse or dependence, recreational use of illicit drugs or prescription medications, or use of medical marijuana within 90 days prior to screening
- Known allergy to local anesthetics
- Concurrent use of anticoagulant medications (e.g. warfarin, heparin) or clopidogrel (Plavix)
- History of known inherited or acquired hypercoagulable states.
- Electrocardiogram demonstrating cardiac arrhythmia, except for sinus tachycardia within the predefined limit of no greater than 105 bpm.
- Use of investigational therapy or treatment within 6 months prior to initial IMP administration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University, St. Louis
St Louis, Missouri, 63110
Study Coordinator, 314-273-0301, luluhuang@wustl.edu
About this study
Official title: A Phase 2a Study of DB-3Q for the Treatment of Medically Refractory Crohn's Disease
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)
- Being tested
- DB-3Q, Placebo
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DB-3QBiological
bmMSC derived, extracellular vesicle enriched secretome product
PlaceboOther
0.9% Saline
| Study group | Role | What they receive |
|---|---|---|
| DB-3Q 15 mL IV | Experimental | Not described Receives: Biological: DB-3Q |
| DB-3Q 30 mL IV | Experimental | Not described Receives: Biological: DB-3Q |
| DB-3Q 45 mL IV | Experimental | Not described Receives: Biological: DB-3Q |
| Placebo IV | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Direct Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625293
- Sponsor's protocol ID
- 3Q-CD-201
- Status last verified
- Aug 2026
- First submitted
- 29 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study of DB-3Q for the Treatment of Medically Refractory Crohn's Disease
- ClinicalTrials.gov ID
- NCT07625293
- Acronym / sponsor ID
- 3Q-CD-201
- Conditions
- Crohn Disease (CD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Direct Biologics, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (42 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DB-3QbmMSC derived, extracellular vesicle enriched secretome product | Biological | DB-3Q 15 mL IV, DB-3Q 30 mL IV, DB-3Q 45 mL IV |
| Placebo0.9% Saline | Other | Placebo IV |
Primary outcome
Change from baseline in SES-CD Score
Time frame: 12 Weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DB-3Q in people with Crohn Disease (CD), run by Direct Biologics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bill Arana (15123547124, barana@directbiologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in SES-CD Score (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.