A Multiple Dose Study to Evaluate Safety, Tolerability, PK, and Efficacy of SER-155 in Adults Undergoing HSCT

Overview

About this study

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and effectiveness of SER-155 in adults undergoing hematopoietic stem cell transplantation to reduce the risk of infection and graft vs. host disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Male and female subjects ≥ 18 years of age undergoing HSCT.

- Planning to undergo allogeneic hematopoietic stem cell transplantation from a human
leukocyte antigen matched sibling, haploidentical related donor, HLA-matched unrelated
donor, or HLA 1-antigen mismatched unrelated donor, with either bone marrow or
peripheral blood stem cells as a graft source, and with any conditioning regimen

Exclusion Criteria:

- Severe colitis of any etiology or active/currently-treated inflammatory bowel disease
(IBD) or total colectomy.

- Evidence of relapse or progression of hematologic malignancy (minimal residual disease
is allowed).

- Transplant using umbilical cord blood or ex vivo T-cell-depleted HSCT

- Receipt of chimeric antigen receptor T-cell (CAR-T) therapy.

- Received a fecal microbiota transplant (FMT) or any live microbial therapeutic within
3 months prior to Screening.

- Known allergy or intolerance to oral vancomycin.

- Concomitant participation or participation within 14 days or 5 half-lives of another
investigational unapproved treatment, whichever is longer.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated12/22/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

William Hogan, M.B., B.Ch.

Closed for enrollment

Contact information:

Anton Mett CCRP

(507) 538-9812

Mett.Anton@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Nandita Khera, M.D., M.P.H.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Hemant Murthy, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available