NCT07509450

Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cell Transplant: A Pilot Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single site pilot trial will evaluate the feasibility and safety of fecal microbiota transplantation (FMT) in patients with B-cell lymphoma who are undergoing CAR-T or in patients with moderate to high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing allogeneic stem cell transplantation.

Detailed description

This is a single centre, non-randomized, single-arm interventional pilot study examining fecal microbiota transplantation in patients undergoing CAR-T or allogeneic stem cell transplantation (alloSCT). 20 eligible patients will be enrolled in this study 10 patients with B-cell lymphoma undergoing CAR-T and 10 patients with AML/MDS undergoing alloSCT. FMT series occurring prior to cellular therapy and 30 days after cellular therapy treatment. Standard of care blood tests including HIV, Hepatitis B and C testing, pregnancy test and physical exam will be done during the study. Blood, urine, rectal swab, stool sample will be collected for correlative studies. Patients will be asked to complete a questionnaire questionnaire on perceptions and acceptability of FMT. The total study duration will be approximately 2.5 years, including 2 years of recruitment, minimum 1 series of FMT treatments and a minimum 6 months of follow-up.

Conditions

• Lymphoma Receiving CAR-T Therapy

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbial Transplant Enema	Rectal infusion of FMT will be administered every 48 hours for 2 doses, on 2 separate occasions, detailed in the study calendar. For each series of FMT administrations, the first dose will be 100g and the second will be 50g. Each FMT will be delivered using a single dose (300 ml of prepared fecal filtrate containing 100g or 50g of stool from a donor) delivered using an enema bag and rectal catheter. The procedure, including preparation steps, will take less than 20 - 30 minutes. The second FMT administration will occur in either the inpatient or outpatient setting depending on whether the patient has been discharged from hospital by the time their second FMT series is due at Day +30. The second FMT series will only occur if patients have a neutrophil count of ANC\>1.0 x 109/L without growth factor support for the last 7 days, documented within 7 days prior to the FMT administration.
BIOLOGICAL	Fecal Microbial Transplant Enema	Rectal infusion of FMT will be administered every 48 hours for 2 doses, on 2 separate occasions, detailed in the study calendar. For each series of FMT administrations, the first dose will be 100g and the second will be 50g. Each FMT will be delivered using a single dose (300 ml of prepared fecal filtrate containing 100g or 50g of stool from a donor) delivered using an enema bag and rectal catheter. The procedure, including preparation steps, will take less than 20 - 30 minutes. The second FMT administration will occur in either the inpatient or outpatient setting depending on whether the patient has been discharged from hospital by the time their second FMT series is due at Day +30. The second FMT series will only occur if patients have a neutrophil count of ANC\>1.0 x 109/L without growth factor support for the last 7 days, documented within 7 days prior to the FMT administration.

Timeline

• Start date: 2026-04-15
• Primary completion: 2029-04-15
• Completion: 2029-04-29
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Canada