DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Direct Biologics

Status and phase: Not yet enrolling; Phase 2

Conditions: Perianal Fistula Due to Crohn's Disease

Treatments: Biological: Placebo; Biological: DB-3Q

Study type: Interventional

Funder types: Industry

Identifiers

NCT06918808

3Q-PFCD-201

Details and patient eligibility

About

This is a double-blind, randomized, placebo-controlled, sequential cohort, ascending dose clinical trial to evaluate the safety and determine the efficacy of ascending doses of DB-3Q for the treatment of Perianal Fistulizing Crohn's Disease.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent from participant
2. Men and women 18-75 years of age with a diagnosis of Crohn's Disease for at least six months duration prior to Day 1
3. Single and/or multi-tract perianal fistula(s) with 2 or fewer openings, that are actively draining
4. Failed at least one medical therapy within the last year including, but not limited to, antibiotics, immunomodulators (6-MP, methotrexate, azathioprine), monoclonal antibodies (adalimumab, certolizumab, golimumab, guselkumab, infliximab, risankizumab, ustekinumab, vedolizumab), or small molecule inhibitors (tofacitinib, upadacitinib)
5. Previous failed surgical intervention, including seton placement at least two weeks prior to screening, or are not candidates for surgical intervention or are not willing to undergo surgical intervention for the management of their fistula
6. Medical therapy for CD stable for at least 2 months prior to Day 1 (Changes in dosing or dosing intervals related to serum drug levels are not permitted)

Exclusion criteria

1. Lack of informed consent
2. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test, or woman who is breast feeding
3. A participant who is unwilling to use medically acceptable contraception methods during participation in study
4. Active perianal abscess or infection at screening or Day 1
5. Clinically significant medical conditions within six months before Day 1 that would, in the opinion of the Investigator, compromise the safety of the participant
6. Confirmed HIV, Hepatitis B, or Hepatitis C infections
7. History of cancer including melanoma (with the exception of localized non-melanoma skin cancers) within one year of screening
8. History of colorectal cancer within 2 years of screening
9. Use of investigational therapy or treatment within 30 days prior to Day 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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36 participants in 6 patient groups, including a placebo group

Single dose DB-3Q 15 mL direct injection

Experimental group

Treatment:

Biological: DB-3Q

Single dose Placebo 15 mL direct injection

Placebo Comparator group

Treatment:

Biological: Placebo

Single dose DB-3Q 30 mL direct injection

Experimental group

Treatment:

Biological: DB-3Q

Single dose Placebo 30 mL direct injection

Placebo Comparator group

Treatment:

Biological: Placebo

Single dose DB-3Q 15 ml IV and DB-3Q 30 mL direct injection

Experimental group

Treatment:

Biological: DB-3Q

Single dose Placebo 15 ml IV and Placebo 30 mL direct injection

Placebo Comparator group

Treatment:

Biological: Placebo