NCT04824794 · OUTCOME

Dose Escalation, Expansion Part A and Expansion Part B: Duration of Response (DOR)

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.

Measure: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: Up to approximately 4 years 3 months

What was measured

DOR was defined as time from first response (PR or better) to timing of disease progression or death (due to any cause), whichever came first.

Analysis population: Full Analysis set=all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed=participants evaluable for the outcome measure with a response.

Groups in this outcome

RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg

Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by 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).

RRMM Dose Escalation: GEN3014 2 mg/kg

Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.

RRMM Dose Escalation: GEN3014 4 mg/kg

Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.

RRMM Dose Escalation: GEN3014 8 mg/kg

Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.

RRMM Dose Escalation: GEN3014 16 mg/kg

Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.

RRMM Dose Escalation: GEN3014 24 mg/kg

Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.

R/R AML Dose Escalation: GEN3014 Dose Level 1

Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.

RRMM Expansion Part A: GEN3014

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.

R/R DLBCL Expansion Part A: GEN3014

Participants with R/R DLBCL received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day cycles during Expansion Part A.

RRMM Expansion Part B: Daratumumab

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.

RRMM Expansion Part B: GEN3014

Participants with anti-CD38 mAb-naive RRMM received GEN3014 IV infusion at a dose of 16 mg/kg in 28-day treatment cycles.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg	0
RRMM Dose Escalation: GEN3014 2 mg/kg	0
RRMM Dose Escalation: GEN3014 4 mg/kg	1
RRMM Dose Escalation: GEN3014 8 mg/kg	0
RRMM Dose Escalation: GEN3014 16 mg/kg	1
RRMM Dose Escalation: GEN3014 24 mg/kg	1
R/R AML Dose Escalation: GEN3014 Dose Level 1	0
RRMM Expansion Part A: GEN3014	6
R/R DLBCL Expansion Part A: GEN3014	1
RRMM Expansion Part B: Daratumumab	22
RRMM Expansion Part B: GEN3014	23

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
RRMM Dose Escalation: GEN3014 4 mg/kg	30.9	Not reported	NA	NA	Could not be estimated due to the low number of events.
RRMM Dose Escalation: GEN3014 16 mg/kg	1.6	Not reported	NA	NA	Could not be estimated due to the low number of events.
RRMM Dose Escalation: GEN3014 24 mg/kg	7.9	Not reported	NA	NA	Could not be estimated due to the low number of events.
RRMM Expansion Part A: GEN3014	7.1	Not reported	2.6	NA	Could not be estimated due to the low number of events.
R/R DLBCL Expansion Part A: GEN3014	1.6	Not reported	Not reported	Not reported	Not reported
RRMM Expansion Part B: Daratumumab	8.3	Not reported	5.6	NA	Could not be estimated due to the low number of events.
RRMM Expansion Part B: GEN3014	7.7	Not reported	4.9	11.5	Not reported

Complete source fields

classes

categories
measurements
comment
Could not be estimated due to the low number of events.
group Id
OG002
lower Limit
NA
upper Limit
NA
value
30.9
comment
Could not be estimated due to the low number of events.
group Id
OG004
lower Limit
NA
upper Limit
NA
value
1.6
comment
Could not be estimated due to the low number of events.
group Id
OG005
lower Limit
NA
upper Limit
NA
value
7.9
comment
Could not be estimated due to the low number of events.
group Id
OG007
lower Limit
2.6
upper Limit
NA
value
7.1
group Id
OG008
value
1.6
comment
Could not be estimated due to the low number of events.
group Id
OG009
lower Limit
5.6
upper Limit
NA
value
8.3
group Id
OG010
lower Limit
4.9
upper Limit
11.5
value
7.7

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
1
group Id
OG005
value
1
group Id
OG006
value
0
group Id
OG007
value
6
group Id
OG008
value
1
group Id
OG009
value
22
group Id
OG010
value
23
units
Participants

description

DOR was defined as time from first response (PR or better) to timing of disease progression or death (due to any cause), whichever came first.

dispersion Type

95% Confidence Interval

groups

description
Participants with RRMM received GEN3014 at a dose of 0.2/0.6 mg/kg by 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
OG000
title
RRMM Dose Escalation: GEN3014 0.2/0.6 mg/kg
description
Participants with RRMM received GEN3014 at a dose of 2 mg/kg by IV infusion in 28-day treatment cycles.
id
OG001
title
RRMM Dose Escalation: GEN3014 2 mg/kg
description
Participants with RRMM received GEN3014 at a dose of 4 mg/kg by IV infusion in 28-day treatment cycles.
id
OG002
title
RRMM Dose Escalation: GEN3014 4 mg/kg
description
Participants with RRMM received GEN3014 at a dose of 8 mg/kg by IV infusion in 28-day treatment cycles.
id
OG003
title
RRMM Dose Escalation: GEN3014 8 mg/kg
description
Participants with RRMM received GEN3014 at a dose of 16 mg/kg by IV infusion in 28-day treatment cycles.
id
OG004
title
RRMM Dose Escalation: GEN3014 16 mg/kg
description
Participants with RRMM received GEN3014 at a dose of 24 mg/kg by IV infusion in 28-day treatment cycles.
id
OG005
title
RRMM Dose Escalation: GEN3014 24 mg/kg
description
Participants with R/R AML received GEN3014 at dose level 1 (low dose) in 28-day treatment cycles.
id
OG006
title
R/R AML Dose Escalation: GEN3014 Dose Level 1
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
OG007
title
RRMM Expansion Part A: GEN3014
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
OG008
title
R/R DLBCL Expansion Part A: GEN3014
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
OG009
title
RRMM Expansion Part B: Daratumumab
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
OG010
title
RRMM Expansion Part B: GEN3014

param Type

MEDIAN

population Description

Full Analysis set=all enrolled participants who received at least 1 dose of trial drug (GEN3014 or daratumumab SC). Overall number of participants analyzed=participants evaluable for the outcome measure with a response.

reporting Status

POSTED

time Frame

Up to approximately 4 years 3 months

title

Dose Escalation, Expansion Part A and Expansion Part B: Duration of Response (DOR)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice