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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/11/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Prashant Kapoor, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20507130

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