A Study to Evaluate a Novel Gene Therapy in Patients With Relapsed and Refractory Multiple Myeloma

a study on Multiple Myeloma Neoplasms Hemostatic Disorders Vascular Disease Paraproteinemias Blood Protein Disorders Hematologic Disease Lymphoproliferative Disorders Immunoproliferative Disorders Gene Therapy

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Jodi Lipof, MD (ucsf)

Description

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.

Official Title

A Phase 1 Study to Evaluate the Safety of KLN-1010, a Novel, In Vivo Gene Therapy to Generate Anti-B Cell Maturation Antigen (Anti-BCMA) Chimeric Antigen Receptor-T Cells (CAR-T) in Patients With Relapsed and Refractory Multiple Myeloma

Keywords

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, in vivo CAR-T, multiple myeloma, BMCA, Neoplasms, Vascular Diseases, Hematologic Diseases, Disease, Immune System Diseases, KLN-1010

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 0-1
  • Participants must have acceptable laboratory values as defined by the protocol

You CAN'T join if...

  • Participants must not have known central nervous system (CNS) involvement with myeloma
  • 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

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Palo Alto California 94304 United States
  • City of Hope accepting new patients
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Jodi Lipof, MD (ucsf)
    Assistant Professor, Medicine, School of Medicine. Authored (or co-authored) 9 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kelonia Therapeutics, Inc.
ID
NCT07075185
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated
Contact us about this trial