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GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies

NCT04824794 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-05-19

Study results available
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Summary

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. In addition to safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed (disease has returned) or refractory (resistant to treatment) 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 identify 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.
3. Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries.

Participants will receive either GEN3014 into the vein or daratumumab under the skin; none will be given 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.

Conditions

  • Relapsed or Refractory Multiple Myeloma (RRMM)
  • Diffuse Large B Cell Lymphoma (DLBCL)
  • Acute Myeloid Leukemia (AML)

Interventions

BIOLOGICAL

GEN3014

GEN3014 is administered by IV infusion.

DRUG

Daratumumab

Daratumumab is administered by SC injections.

Sponsors & Collaborators

  • Genmab

    lead INDUSTRY

Principal Investigators

  • Study Official · Genmab

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2025-06-30
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bosnia and Herzegovina
  • Czechia
  • Denmark
  • France
  • Georgia
  • Greece
  • Hungary
  • Malaysia
  • Moldova
  • Netherlands
  • New Zealand
  • North Macedonia
  • Philippines
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824794 on ClinicalTrials.gov