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

July 6, 2026 updated by: University Health Network, Toronto
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • University Health Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women ≥ 18 years of age

  2. Diagnosis of the following:

    1. Indolent or aggressive B-cell lymphoma eligible for standard or care CAR-T therapy (Cohort A), or
    2. Patients with AML or high risk MDS with indication to undergo reduced-intensity conditioning alloSCT, with an available matched related, unrelated, or haploidentical donor (Cohort B)
  3. ECOG 0-1

  4. Adequate marrow function defined by:

    1. Hemoglobin >80 g/L without transfusion dependence within the last 7 days
    2. Platelet count >20 x 109/L without transfusion dependence within the last 7 days
    3. Neutrophil count >1.0 x 109/L without growth factor support within the last 7 days
  5. Adequate liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 1.5 x ULN (unless documented Gilbert's syndrome)
  6. Adequate renal function as defined as creatinine clearance ≥ 30 mL/min directly measured with a 24-hour urine collection or calculated according to the modified formula of Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) calculation
  7. Life expectancy >6 months
  8. Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of protocol therapy. Men who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of protocol therapy. Men require an agreement to remain abstinent (ie, refrain from heterosexual intercourse) or use a condom, and an agreement to refrain from donating sperm. Periodic abstinence and withdrawal are not acceptable methods of contraception. Fertility preservation options should be discussed. Examples of highly effective contraceptive methods include an agreement to remain abstinent (ie, refrain from heterosexual intercourse), bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  9. Willing and able to participate in all required evaluations and procedures in this study.
  10. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

  1. For patients undergoing alloSCT (Cohort B): plan to undergo myeloablative conditioning
  2. Use of investigational agents within the last 4 weeks before enrollment.
  3. Active or uncontrolled infection
  4. Autoimmune disorder currently being treated with disease-modifying therapy or with >10mg/day prednisone
  5. Inflammatory bowel disease
  6. History of intestinal perforation
  7. Gastrointestinal surgical procedure within the past 4 weeks before enrollment
  8. Pregnant or breast-feeding patients
  9. HIV infection with detectable viral load or CD4 count <200

  10. Serologic status reflecting active hepatitis B or C infection as follows:

    1. Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA. (Note, patients with undetectable HBV DNA are permitted to enroll if they are on Hepatitis B suppressive therapy)
    2. Patients with presence of hepatitis C virus (HCV) antibody and HCV RNA detectable
  11. History of infection or known colonization with antibiotic resistant organism in the last two years before enrollment (including ESBL, MRSA, VISA, VRSA, VRE, CPE)
  12. Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CAR-T cell transplant
Patients will receive Fecal microbiota transplantation and CAR-T cell infusion
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.
Experimental: Allogenic stem cell transplant
Patients will receive Fecal microbiota transplantation and allogenic cell trnsplant
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the feasibility of fecal microbiota transplantation (FMT) in patients undergoing CAR-T or allogeneic stem cell transplantation.
Time Frame: 2.5 years
The study hypothesizes successful recruitment of at least 50% of approached patients, retain at least 80% of patients on the study, and successfully administer at least one FMT series to 80% of retained patients.
2.5 years
To evaluate the safety of fecal microbiota transplantation (FMT) in patients undergoing CAR-T or allogeneic stem cell transplantation.
Time Frame: 2.5 years
The study hypothesizes that FMT will be safe in this population. Each cohort will be considered separately in considering the differing risks of CAR-T and alloSCT. The study hypothesizes that in each cohort there will be no greater than 10% incidence (N< 1 of 10 participants in each cohort), of serious adverse events, or Grade >3 adverse events of special interest (sepsis and/or bacteremia, ICU admission, bowel perforation, or death) within 48 hours of administration of FMT, which are judged to be possibly, probably or definitely related to FMT.
2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMT Pilot Study
  • OZUHN-038 (Other Identifier: Ozmosis Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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