Study of ISB 1342, a CD38/CD3 Bispecific Antibody, in Subjects With Previously Treated Multiple Myeloma

Overview

The purpose of this study is to determine the safety profile, maximum tolerable dose (MTD) and cohort expansion of single-agent ISB 1342 in subjects with multiple myeloma who have received prior therapies.

SparkCures ID 919
Trial Phase Phase 1/2
Enrollment 245 Patients
Treatments
Tags
Trial Sponsors
  • Ichnos Sciences SA
Trial Collaborators
  • Glenmark Pharmaceuticals S.A.
NCT Identifier

NCT03309111

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

Inclusion Criteria:

  • Documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per International Myeloma Working Group (IMWG) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (PIs), immunomodulators (IMiDs) and anti-CD38 targeted therapies (daratumumab, isatuximab).
  • Eastern Cooperative Oncology Group (ECOG) performance-status score of 2 or less and 1 or less (for France).
  • Adequate hematologic, renal, and hepatic functions
  • Seronegative for hepatitis B antigen; positive hepatitis B tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled.
  • Seronegative for hepatitis C antibody; if positive, then further test for the presence of antigen by hepatitis C virus polymerase chain reaction (HCV PCR). If HCV antigen tests are negative, then the subject can be enrolled.
  • Oxygen saturation level ≥92% on room air.
  • Left ventricular ejection fraction (LVEF) ≥50% and no pericardial or pleural effusion at Screening

Exclusion Criteria:

  • Active central nervous system involvement
  • Exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment
  • Active plasma cell leukemia
  • Active infectious disease
  • Clinically significant cardiovascular and respiratory conditions
  • History of HIV infection
  • Subjects requiring prohibited concomitant medications

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Memorial Sloan Kettering Cancer Center

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Maryland
Minnesota
Mayo Clinic (Rochester)

Rochester, MN

New York
Verified Memorial Sloan Kettering Cancer Center

SparkCures Verified Accurate, up-to-date information. Learn more


North Carolina
Tennessee

Resources

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