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GEN3014 Safety Trial in Relapsed or Refractory Hematologic Malignancies

Cancer Type
Hematopoietic Malignancies
Multiple Myeloma
Trial Phase
Phase I
Phase II
18 Years and older, Male and Female
Study Type
Protocol IDs
GCT3014-01 (primary)
Study Sponsor


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 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

3. Expansion Part B will compare intravenous (IV) GEN3014 with the approved multiple
myeloma drug, subcutaneous (SC) daratumumab. Participants in the US will not participate
Expansion Part B.

Participants will receive either investigational GEN3014 or daratumumab; 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.


This trial will be conducted in 3 parts: Dose Escalation (phase 1), Expansion Parts, A and B
(phase 2).

All participants in the Dose Escalation, GEN3014 will be evaluated in RRMM and R/R AML, will
receive GEN3014, administered at various dose levels in 28-day cycles. Dose Limiting
Toxicities (DLTs) will be assessed during the first treatment cycle and the Maximum Tolerated
Dose (MTD) and/or Recommended phase 2 dose (RP2D) will be determined.

Expansion Part A, GEN3014 will be further evaluated in 4 cohorts: anti-CD38 mAb-naive RRMM,
anti-CD38 mAb-refractory RRMM, R/R DLBCL, and R/R AML at the RP2D identified from the Dose
Escalation per protocol. Expansion Part B, GEN3014 IV will be compared to daratumumab SC,
head-to-head (H2H) to evaluate whether GEN3014 may be more potent in anti-CD38 mAb-naïve RRMM


  1. Must have fresh bone marrow samples collected at Screening.
  2. Dose Escalation phase, Expansion part A (for MM and AML) and Expansion part B- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2. Expansion part A (for DLBCL): ECOG PS 0 or 1.
  3. Expansion part A - Has acceptable laboratory test results during the Screening period.
  4. A woman of reproductive potential must agree to use adequate contraception during the trial and for 12 months after the last GEN3014 or daratumumab SC administration.
  5. A woman of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) at Screening and additionally, for Expansion Part B, within 72 hours of the first dose of study treatment prior to dosing.
  6. A woman must agree not to donate eggs (ova, oocytes) for assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC.
  7. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control and all men must not donate sperm during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC. Specific for RRMM:
  8. Must have documented multiple myeloma as defined by the criteria below and have evidence of disease progression on the most recent prior treatment regimen based on IMWG criteria:
  9. Prior documentation of monoclonal plasma cells in the bone marrow =10% or presence of a biopsy-proven plasmacytoma and,
  10. Measurable disease at baseline as defined by any of the following:
  11. Immunoglobulin (Ig) G, IgA, IgD, or IgM myeloma: Serum M-protein level =0.5 g/dL (=5 g/L) or urine M protein level =200 mg/24 hours or,
  12. Light chain myeloma: Serum Ig free light chain (FLC) =10 mg/dL and abnormal serum Ig kappa lambda FLC ratio. Note: Participants with RRMM must have exhausted standard therapies, at the investigator's discretion.
  13. For anti-CD38 mAb-naive RRMM Cohort: Participant received at least 3 prior lines of therapy including a PI and an IMiD in any order, or is double refractory to a PI and an IMiD; or participant received = 2 prior lines of therapy if 1 of those lines included a combination of PI and IMiD. Note: Participants should not have received any anti-CD38 antibody.
  14. Anti-CD38 mAb-naive RRMM subjects will be enrolled from ex-US countries
  15. Dose Escalation phase - For anti-CD38 mAb-treated RRMM Cohort: Participant has received at least 2 prior lines of therapy and must have discontinued daratumumab or isatuximab for at least 4 weeks prior to the first dose of GEN3014. Note: Participants should not have received any other anti-CD38 antibody except daratumumab or isatuximab. Specific for R/R AML:
  16. Relapsed or refractory AML, both de novo or secondary; must have failed all conventional therapy. Acute promyelocytic leukemia (APL) is excluded from this trial.
  17. Participant with relapsed AML who received at least 2 prior therapies for AML with the exception of hydroxyurea.
  18. Participant with refractory AML who received at least 1 prior line of therapy for AML with the exception of hydroxyurea.
  19. Participant's life expectancy at Screening is judged to be at least 3 months. Specific for DLBCL:
  20. Expansion phase: Relapsed or refractory DLBCL, both de novo or histologically transformed. Participants with R/R DLBCL must have exhausted standard therapies, at the investigator's discretion.
  21. Expansion phase: Received at least 2 prior lines of systemic therapy, with 1 being a CD20-containing chemoimmunotherapy.
  22. Expansion phase: Have at least 1 measurable site of disease as per Lugano criteria.
  23. Expansion phase: Must have available archival or fresh tumor tissue or both to submit to a central laboratory for CD38 assay.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

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