Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of cilta-cel out-of-specification (OOS).

Official Title

A Safety and Efficacy Study of JNJ-68284528 (Ciltacabtagene Autoleucel) Out-of-Specification (OOS) for Commercial Release in Patients With Multiple Myeloma

Keywords

Multiple Myeloma Neoplasms, Plasma Cell Cyclophosphamide Fludarabine Cilta-cel Lymphodepleting Therapy (Cyclophosphamide and Fludarabine) Ciltacabtagene Autoleucel (Cilta-cel)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Eligible for treatment with cilta-cel per United States prescribing information (USPI) or locally approved label
  • Participant is suffering from serious or life threatening multiple myeloma per USPI (or locally approved label, respectively), and re-apheresis, re-manufacturing, or other anti-myeloma directed therapies is not considered feasible or adequate per investigator
  • Has adequate general health status and organ function per investigator assessment and meets the criteria to receive cilta-cel out-of-specifications (OOS)
  • Meets the criteria to receive lymphodepleting chemotherapy
  • A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at consenting and prior to the first dose of cyclophosphamide and fludarabine

You CAN'T join if...

  • History of active uncontrolled infection or condition where an administration of cilta-cel OOS constitutes serious health risk to the participant
  • Known allergies, hypersensitivity, or intolerance to the excipients of cilta-cel OOS including dimethyl sulfoxide (DMSO), dextran 40, or residual kanamycin per USPI
  • Hepatitis B infection
  • Hepatitis C infection defined as (anti hepatitis C virus [HCV] antibody positive or detectable HCV ribonucleic acid [RNA]) or known to have a history of hepatitis C
  • Seropositive for human immunodeficiency virus (HIV)
  • Uncontrolled autoimmune disease

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Stanford University Medical Center not yet accepting patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Scientific Affairs, LLC
ID
NCT05347485
Phase
Phase 2 Multiple Myeloma Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated