Phase 1/2 Study of ISB 1442 in Relapsed/Refractory Multiple Myeloma

What's the purpose of this trial?

This study is a first-in-human, Phase 1/2, open label study that will evaluate safety and efficacy of ISB 1442 in relapsed/refractory multiple myeloma (R/R MM).

This is an upcoming trial that has not yet started accepting patients.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Male or female patients aged 18 years or older.
  • Be willing and able to provide written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act of 1996 [HIPAA]) prior to any protocol related procedures, including screening evaluations
  • Phase 1: Patients with pathologically confirmed multiple myeloma (MM) who have progressed on or after standard therapy (relapsed/refractory [R/R] patients):
    • Must have received at least 3 prior lines of therapy, including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit. (Note: Patients in Australia may have received any of the therapies including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent; and must not be candidates for regimens known to provide clinical benefit ).
  • Must have measurable M-protein (serum and/or 24-hr urine, or serum free light chains).
  • Phase 2: Patients with pathologically confirmed MM who have progressed on or after standard therapy (R/R patients):
    • Cohort A: R/R MM
      • Must have received at least 3 prior lines of therapy, including PIs, IMiDs, and anti CD38 therapies either in combination or as a single agent;
      • Must have measurable disease defined by at least 1 of the following abnormalities (as per IMWG criteria):
        • Serum M-protein ≥ 0.5 g/L (IgA ≥ 0.5 g/L), or
        • Urine light-chain (M-protein) of ≥ 200 mg/24 hours, or
        • Serum free light chain (sFLC) assay: involved free light chain (FLC) level ≥ 10 mg/dL provided sFLC ratio is abnormal.
    • Cohort B: R/R MM Post-T-Cell Directed Therapy
      • Must have received at least 3 prior lines of therapy, including PIs, IMiDs and anti-CD38 therapies either in combination or as a single agent; and have relapsed and/or be refractory to a T-cell directed therapy including cellular therapies or T cell engagers.
      • Must have measurable disease defined by at least 1 of the following abnormalities (as per IMWG criteria):
        • Serum M-protein ≥ 0.5 g/L (IgA ≥ 0.5 g/L), or
        • Urine light-chain (M-protein) of ≥ 200 mg/24 hours, or
        • sFLC assay: involved FLC level ≥ 10 mg/dL provided sFLC ratio is abnormal
  • Have a body weight ≥ 40.0 kg at screening.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
  • Have life expectancy of at least 3 months (from date of informed consent signing).
  • Have adequate organ function, including:
    • Aspartate aminotransferase (AST, GOT) and alanine aminotransferase (ALT, GPT) ≤3.0 × ULN; bilirubin ≤1.5 × ULN. Patients with Gilbert's syndrome may have a bilirubin level >1.5 × ULN, per discussion between the Investigator and medical monitor.
    • Estimated creatinine clearance ≥45 mL/min as calculated using the Cockcroft-Gault formula or 24-hour urine collection.
  • Left ventricular ejection fraction (LVEF) ≥45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) scan.

Exclusion Criteria:

  • Participants with relapsed disease where relapse is characterized only by minimal residual disease parameters (i.e., minimal residual disease positive).
  • Participants with MM with disease where the only measurable parameter is plasmacytoma.
  • Received treatment with anti-CD38 antibodies or CD47 targeted therapies within 1 month of C1D1; systemic anticancer treatments within 14 days before the first dose of study drug (C1D1) or any investigational products within 5 half-lives of C1D1, whichever is appropriate to last therapy received. (eg, non-IMP IMiD, proteasome inhibitor could be considered to be eligible if there is at least 14 days after last dose before C1D1. Note: Treatment with a single course of glucocorticoids is allowed (maximum dose of corticosteroids should not exceed the equivalent of 160 mg [for example, 40 mg/d for 4 days] of dexamethasone). Hormonal therapy for prostate cancer or breast cancer (as adjuvant treatment), and treatment with bisphosphonates and receptor activator of nuclear factor kappa-Β ligand inhibitors are allowed.
  • Received autologous stem cell transplantation within 12 weeks of C1D1.
  • Current participation in another interventional study, including other clinical trials with investigational agents (including investigational vaccines or investigational medical device for disease under study) within 4 weeks of C1D1 and throughout the duration of this trial.
  • Prior radiation therapy within 14 days of C1D1; or prior irradiation to > 25% of the bone marrow. Note: Prophylactic localized ("spot") radiation for areas of pain is allowed.
  • Active malignant central nervous system involvement
  • Known to be refractory to platelet or RBC transfusions
  • Known severe allergic or anaphylactic reactions to human recombinant proteins or excipients used in the ISB 1442 formulation.
  • QTc interval > 480 msec at screening using Fredericia's QT correction formula.

Additional Trial Information

Phase 1/2

Enrollment: 121 patients (estimated)

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Trial Locations

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New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Not Yet Accepting

Trial Links

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