GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Genmab
Study ID
NCT04824794
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GEN3014 — BIOLOGICAL
    GEN3014 is administered by IV infusion.
  • Daratumumab — DRUG
    Daratumumab is administered by SC injections.

Study Details

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.

Key Dates

Start date
Mar 9, 2021
Status verified
Apr 2026
Primary completion
Jun 30, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
130 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: GEN3014
    Experimental: GEN3014 Participants in Dose Escalation phase with * RRMM * R/R AML Participants in Expansion Part A with * RRMM (anti-CD38 mAb-naïve) * RRMM (anti-CD38 mAb-refractory) * R/R DLBCL * R/R AML Participants in Expansion Part B with • RRMM (anti-CD38 mAb-naïve)
  • Active Comparator: Daratumumab
    Participants in Expansion Part B with \- RRMM (anti-CD38 mAb-naïve)

Primary Outcome Measure

Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: 28 days during the first cycle (cycle =28 days) ]

Locations (3)

FacilityCityStateZIPSite coordinators
John Theurer Cancer CenterHackensackNew Jersey07601-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Medical college of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Hackensack, NJ

By research site
John Theurer Cancer Center· Hackensack, NJUniversity Hospitals Cleveland Medical Center· Cleveland, OHMedical college of Wisconsin· Milwaukee, WI

Related Studies