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NCT04824794 · FLOW

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GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies · Source last updated 2026-05-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Participants with RRMM received GEN3014 at a dose of 0.2/0.6 milligrams per kilogram (mg/kg) by intravenous (IV) infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
    id
    FG000
    title
    RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
  2. description
    Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG001
    title
    RRMM Dose Escalation: GEN3014 2 mg/kg
  3. description
    Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG002
    title
    RRMM Dose Escalation: GEN3014 4 mg/kg
  4. description
    Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG003
    title
    RRMM Dose Escalation: GEN3014 8 mg/kg
  5. description
    Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG004
    title
    RRMM Dose Escalation: GEN3014 16 mg/kg
  6. description
    Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG005
    title
    RRMM Dose Escalation: GEN3014 24 mg/kg
  7. description
    Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
    id
    FG006
    title
    R/R AML Dose Escalation: GEN3014 Dose Level 1
  8. description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
    id
    FG007
    title
    RRMM Expansion Part A: GEN3014
  9. description
    Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
    id
    FG008
    title
    R/R DLBCL Expansion Part A: GEN3014
  10. description
    Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
    id
    FG009
    title
    RRMM Expansion Part B: Daratumumab
  11. description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
    id
    FG010
    title
    RRMM Expansion Part B: GEN3014
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        9
      11. group Id
        FG010
        num Subjects
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        6
      type
      Lost to Follow-Up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Early Site Closure
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        30
      11. group Id
        FG010
        num Subjects
        26
      type
      Sponsor Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Started New Line Of Therapy Due To Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Started New Line Of Treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        7
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        11
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        43
      11. group Id
        FG010
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        11
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        43
      11. group Id
        FG010
        num Subjects
        45
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        11
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        43
      11. group Id
        FG010
        num Subjects
        45
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This study had 3 parts (Dose Escalation, Expansion Part A \& Part B) and was terminated early. Due to enrollment challenges, the acute myeloid leukemia (AML) Dose Escalation and diffuse large B-cell lymphoma (DLBCL) Expansion Part A cohorts were terminated early. The anti-CD38 monoclonal antibody (mAb)-refractory relapsed or refractory multiple myeloma (RRMM) Cohort and relapsed or refractory (R/R) AML Cohort in Expansion Part A were not opened.
Complete source fields
groups
  1. description
    Participants with RRMM received GEN3014 at a dose of 0.2/0.6 milligrams per kilogram (mg/kg) by intravenous (IV) infusion in 28-day treatment cycles. Intraparticipant dose escalation was performed in this arm (i.e., dose was escalated from 0.2-0.6 mg/kg).
    id
    FG000
    title
    RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
  2. description
    Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG001
    title
    RRMM Dose Escalation: GEN3014 2 mg/kg
  3. description
    Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG002
    title
    RRMM Dose Escalation: GEN3014 4 mg/kg
  4. description
    Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG003
    title
    RRMM Dose Escalation: GEN3014 8 mg/kg
  5. description
    Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG004
    title
    RRMM Dose Escalation: GEN3014 16 mg/kg
  6. description
    Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
    id
    FG005
    title
    RRMM Dose Escalation: GEN3014 24 mg/kg
  7. description
    Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
    id
    FG006
    title
    R/R AML Dose Escalation: GEN3014 Dose Level 1
  8. description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
    id
    FG007
    title
    RRMM Expansion Part A: GEN3014
  9. description
    Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.
    id
    FG008
    title
    R/R DLBCL Expansion Part A: GEN3014
  10. description
    Participants with anti-CD38 mAb-naive RRMM received daratumumab at a dose of 1,800 mg by subcutaneous (SC) injection in 28-day treatment cycles.
    id
    FG009
    title
    RRMM Expansion Part B: Daratumumab
  11. description
    Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.
    id
    FG010
    title
    RRMM Expansion Part B: GEN3014
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        5
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        9
      11. group Id
        FG010
        num Subjects
        4
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        2
      11. group Id
        FG010
        num Subjects
        6
      type
      Lost to Follow-Up
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        2
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Early Site Closure
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        2
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        4
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        30
      11. group Id
        FG010
        num Subjects
        26
      type
      Sponsor Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Started New Line Of Therapy Due To Disease Progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        1
      type
      Started New Line Of Treatment
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        7
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        11
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        43
      11. group Id
        FG010
        num Subjects
        45
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        11
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        43
      11. group Id
        FG010
        num Subjects
        45
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        11
      6. group Id
        FG005
        num Subjects
        5
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        11
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        43
      11. group Id
        FG010
        num Subjects
        45
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This study had 3 parts (Dose Escalation, Expansion Part A \& Part B) and was terminated early. Due to enrollment challenges, the acute myeloid leukemia (AML) Dose Escalation and diffuse large B-cell lymphoma (DLBCL) Expansion Part A cohorts were terminated early. The anti-CD38 monoclonal antibody (mAb)-refractory relapsed or refractory multiple myeloma (RRMM) Cohort and relapsed or refractory (R/R) AML Cohort in Expansion Part A were not opened.

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