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

Purpose

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.

Condition

  • Relapsed/Refractory Multiple Myeloma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ISB 1342 		Part 1: Cohorts of multiple ISB 1342 dose levels; Part 2: One dose regimen until disease progression or other discontinuation criterion is met
  • Biological: ISB 1342
    ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion or subcutaneous injection (SC)

Recruiting Locations

Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21287
Contact:
Carol Ann Huff, MD
huffca@jhmi.edu

Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota 55905
Contact:
Prashant Kapoor, MD
Kapoor.Prashant@mayo.edu

Mount Sinai Beth Israel
New York, New York 10029
Contact:
Joshua Richter, MD
joshua.richter@mountsinai.org

Memorial Sloan-Kettering Cancer Center
New York, New York 10065
Contact:
Alexander Lesokhin, MD
lesokhia@mskcc.org

Duke Clinical Research Institute
Durham, North Carolina 72205
Contact:
Cristiana Costa Chase, MD
cristiana.costa@duke.edu

Tennessee Oncology
Nashville, Tennessee 37203
Contact:
Jesus Berdeja, MD
jberdeja@tnonc.com

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Sanjay Mohan, MD
sanjay.mohan@vumc.org

More Details

NCT ID
NCT03309111
Status
Recruiting
Sponsor
Ichnos Sciences SA

Study Contact

Ichnos Sciences Clinical Trials Administrator
(315) 583-1249
clinicaltrials@ichnossciences.com

Detailed Description

This study is an open-label, multi-center, Phase 1 study of ISB 1342 in subjects with relapsed/refractory multiple myeloma refractory to proteasome inhibitors (PIs), immunomodulators (IMiDs), and daratumumab. There will be a dose escalation phase (Part 1) and dose expansion phase (Part 2). In Part 1 of the study, subjects will be treated at escalating dose levels. Once the recommended part 2 dose (RP2D) of ISB 1342 is declared in Part 1, the expansion phase (Part 2) will be initiated at the RP2D.