Recruiting
Phase 1

LBP-MARCO & Ruxolitinib

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07913672

Conditions

Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ruxolitinib

LBP- MARCO

Study Details

Brief summary:

The researchers are doing this study to find out whether the combination of LBP-MARCO (Microbiota Augmentation to Reestablish Commensal Organisms) and ruxolitinib is a safe treatment for people with graft-versus-host disease (GVHD) after receiving a stem cell (allogeneic hematopoietic cell transplantation).

Conditions

Transplant Failure or Rejection of Bone Marrow (Graft vs Host Disease, GVHD)

Study ID

NCT07913672

Start date

Oct 27, 2026

Status verified date

Oct, 2026

Completion date

Oct 27, 2028

Anticipated

Primary completion date

Oct 27, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18
  • Ability to swallow capsules
  • Have undergone allo-HCT from any donor source
  • Upper GI aGVHD stage 1 and/or lower GI aGVHD stage 1-4. aGVHD affecting other organs (e.g. skin, liver) are allowed

  • Steroid-refractory, steroid-dependent or intolerant, defined as:
  • Progressive (i.e., increase in stage of the lower GI tract) after 3 days of treatment with corticosteroids (≥1 mg/kg/day prednisone or IV equivalent), or
  • Failure to improve (i.e., decrease in stage in the GI tract) after 5 days of corticosteroid treatment (≥1 mg/kg/day prednisone or IV equivalent), or
  • Incomplete response after >28 days of corticosteroids, or
  • Corticosteroid dependent (inability to taper prednisone <1 mg/kg/day or recurrence of aGVHD activity or flare during steroid taper), or
  • Corticosteroid intolerance (unacceptable toxicity due to the use of corticosteroids).
  • Absolute neutrophil count (ANC) ≥0.5 x10\^9/L and platelets >20,000/mm3. Use of growth factor supplementation and platelet transfusional support is allowed
  • Ability to start ruxolitinib therapy for aGVHD

Exclusion Criteria:

Has received more than one systemic treatment for aGVHD other than corticosteroids +/- CNI or sirolimus prophylaxis or treatment

  • Active GI bleeding requiring intervention or transfusional support
  • Toxic megacolon
  • Active uncontrolled infection requiring systemic antibiotic treatment including persistent bacteremia (controlled infection receiving definitive therapy for 48 hours prior to enrollment are eligible).
  • Treatment with broad spectrum antibiotic with anaerobic coverage for 48 hours prior to enrollment
  • Elevated total bilirubin not caused by GVHD or Gilbert's disease of >5 x upper limit of normal (ULN)
  • Use of investigational agent within 14 days pre-treatment
  • Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
  • Uncontrolled psychiatric illness
  • Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 3 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance
  • Female patient who is pregnant or breastfeeding
  • Known allergy or sensitivity to ruxolitinib and/or MARCO live biotherapeutic

Study Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Consortia A

Participants in Cohort 1 will receive LBP-MARCO with the same combination of 7 specific types of bacteria.

experimental: Consortia B

If the bacteria do not grow or produce enough metabolites, the next group of participants (Cohort 2) will get LBP-MARCO with a different combination of bacteria.

experimental: Consortia C

If that combination does not grow in participants' guts, the next group of participants (Cohort 3) will get LBP-MARCO with a different combination of the bacteria.

Interventions

Ruxolitinib

Ruxolitinib will be initiated concurrently with LBP treatment at a starting dose of 10 mg twice daily and will continue for at least 28 days.

LBP- MARCO

The LBP-MARCO consists of five capsules of individual bacterial strains that will be given at least 1 day apart from one another and within 7-10 days of the first dose.

Primary outcome measure

  • incidence and severity of SAEs [ Time Frame: up to 100 days ]

Central Contacts and Locations

Central contacts

Doris Ponce, MD

646-608-3739ponced@mskcc.org

Jonathan Peled, MD

646-888-2803

Locations

Memorial Sloan Kettering Basking Ridge (Consent Only)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Doris Ponce, MD

646-608-3739

Memorial Sloan Kettering Monmouth (Consent Only)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Doris Ponce, MD

646-608-3739

Memorial Sloan Kettering Bergen (Consent Only)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Doris Ponce, MD

646-608-3739

Memorial Sloan Kettering Suffolk-Commack (Consent Only)

Recruiting

Commack, New York, United States, 11725

Contacts

Doris Ponce, MD

646-608-3739

Memorial Sloan Kettering Westchester (Consent Only)

Recruiting

Harrison, New York, United States, 10604

Contacts

Doris Ponce, MD

646-608-3739

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Doris Ponce, MD

646-608-3739

Memorial Sloan Kettering Nassau (Consent Only)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Doris Ponce, MD

646-608-3739

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Keywords

  • Rauxolitinibfor
  • Live Biotherapeutic Product
  • Microbiota Augmentation to Reestablish Commensal Organisms)
  • allo-HCT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.