Trial NCT07075185
A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma
- Phase
- Phase 1
- Sponsor
- Kelonia Therapeutics, Inc.
- Conditions
- Multiple Myeloma in Relapse; Myeloma Multiple; Multiple Myeloma Progression; Neoplasms by Histologic Type; Neoplasm; Hemostatic Disorders; Vascular Disorder; Paraproteinemias; Blood Protein Disorders; Hematologic Disease and Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Disease; Gene Therapy
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Participants must have relapsed and refractory multiple myeloma (RRMM) with measurable disease
* Participants must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and CD38-directed monoclonal antibody
* Participants must have an Eastern Cooperative Group (ECOG) performance status of 0-1Performance status
* Participants must have acceptable laboratory values as defined by the protocol
Exclusion Criteria:
* Participants must not have known central nervous system (CNS) involvement with myelomaBrain metastases
* Participants cannot have plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, or primary light chain amyloidosis
* Participants cannot have ongoing acute systemic infection requiring antimicrobial therapy
* Participants cannot require systemic steroids for any condition
Restrictions found (2)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County