GEN3014

An Open-Label, Multicenter, Phase 1/2 Trial of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies

Study No: GEN3014 

Study Overview: The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. Besides safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess the preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed or refractory multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts:

1. The Dose Escalation will test increasing doses of GEN3014 to find a safe dose level to be tested in the other two parts.
2. Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation Part.
3. Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries.

Participants will receive either GEN3014 or daratumumab; none will be given a placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment

Condition/Disease:

1. Relapsed or Refractory Multiple Myeloma (RRMM)
2. Diffuse Large B Cell Lymphoma (DLBCL)
3. Acute Myeloid Leukemia (AML)
   

Intervention / Treatment: GEN3014 (Biological), Daratumumab (Drug)

Study Start: 9-3-2021

Enrollment: Ongoing

Study Phase: Expansion Part B (phase 2)

Investigator site:

Sponsor: Genmab