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

What's the purpose of this trial?

The purpose of this study is to assess safety, efficacy, pharmacokinetic (PK)/pharmacodynamic (PD), and immunogenicity with ISB 1342 in subjects with relapsed/refractory multiple myeloma.

This trial is currently open and 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:

  • 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

Additional Trial Information

Phase 1/2

Enrollment: 245 patients (estimated)

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Published Results

Initial Results of Dose Escalation of ISB 1342, a Novel CD3xCD38 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM)

July 07, 2022

As of July 7, 2022, 24 patients had received a once weekly, IV infusion of ISB 1342 in 6 dose-escalation groups from 0.2/0.3 mg/kg dose level to 1.0 / 4.0 mg/kg dose level. The majority were males (63%) and white (67%); 21% were black or African American. The median age was 67 years (range, 54-76) and the median disease duration since onset was 6.7 years (range, 2.8-22.2). The median number of prior anti-myeloma lines of therapy was 6 (range 1-10); 8 (33%) patients had received prior B cell maturation antigen (BCMA)-targeted therapy including bi-specifics, antibody drug conjugates (ADCs) and/or cell therapies. Twenty-one (88%) patients were considered to be triple-refractory and 18 (75%) were considered to be penta-refractory. Twenty-two (92%) patients experienced treatment-related adverse events (TRAEs) of any grade. Most TRAEs were grade 1-2, including infusion related reactions (42%), anemia (21%), cytokine release syndrome (CRS, 17%), thrombocytopenia (17%), and diarrhoea (13%). Nine (38%) patients had grade 3 or higher TRAEs with only infusion related reactions occurring in more than 5% of patients (17%, all grade 3 events). No grade 5 TRAE was observed. One dose limiting toxicity (DLT), a Grade 3 delirium was observed in a 73-year-old patient treated at 0.3/0.55 dose level after the third dose of ISB 1342, and who also presented with Grade 4 pneumonia; three additional patients were enrolled at that dose level, no other DLT was observed, and dose escalation continued. The median duration of treatment was 2 months (range, 1-5). The ISB 1342 serum concentration-time profiles showed Cmax near the end of infusion, followed by a biphasic decline. The serum exposures showed a dose-dependent increase following both Q2W and Q1W regimens. With the Q1W regimen, the serum Ctrough was higher than that with the Q2W regimen at similar dose levels. Transient increases in serum cytokine levels were observed within 24 hours following ISB 1342 administration, including IFNg, TNFa, IL-2, IL-6 and IL-10.

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Kentucky

Norton Cancer Institute (St. Matthews) St. Matthews Campus

Louisville, KY

Open and Accepting

Maryland

Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Medicine

Baltimore, MD

Open and Accepting

Minnesota

Mayo Clinic (Rochester)

Rochester, MN

Open and Accepting

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Open and Accepting

North Carolina

Duke Cancer Center Duke University Medical Center

Durham, NC

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Vanderbilt-Ingram Cancer Center Henry-Joyce Cancer Clinic

Nashville, TN

Open and Accepting
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