A Phase IB Study of SER-155 in Adults Who Will Receive a Stem Cell Transplant and Are at Risk of Infections and Graft-versus-Host Disease

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Full Title

A Phase 1b Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of SER-155 in Adults Undergoing Hematopoietic Stem Cell Transplantation to Reduce the Risk of Infection and Graft vs. Host Disease

Purpose

Patients receiving an allogeneic stem cell transplant (blood-forming cells from a healthy donor) may have an increased risk of developing an infection and/or a disease called graft-versus-host disease(GVHD). GVHD occurs when the stem cells from the donor attack the organs and tissues in the recipient’s body, causing serious health problems. GVHD can affect the skin, liver, stomach, and intestines and may be mild or severe.

The treatment during and after a stem cell transplant may affect the balance of various kinds of bacteria found in the small intestine or colon (the gut “microbiome”), which may make it more difficult to fight infections and/or increase the risk of GVHD. Researchers think that an investigational treatment called SER-155 may be able to prevent infections and GVHD in people who receive a stem cell transplant.

SER-155 is a capsule made from naturally occurring, healthy bacteria that will replace the bacteria in the gut, which may reduce the risk of infections and GVHD. Researchers are doing this study to find out if SER-155 is a safe and effective treatment that can prevent infections and GVHD after a stem cell transplant.

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants in this study must be planning to receive a stem cell transplant from a donor.
  • People with a history severe colitis (colon inflammation), inflammatory bowel disease, or total colectomy (removal of the colon) may not participate.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Doris Ponce at 646-608-3739.

Protocol

21-319

Phase

I

Investigator

Co-Investigators