NCT03430011 · OUTCOME

Area Under the Concertation-Time Curve (AUC) From Time Day 1 to Day 29 [AUC (0-28 Days)]

Study Evaluating the Safety and Efficacy of JCARH125 in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-05-24

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

Measure: GEOMETRIC_MEAN
Unit: Day*copies/UG
Interval / dispersion: Geometric Coefficient of Variation
Time frame: From JCARH125 infusion through 28 days after the infusion

What was measured

AUC (0-28) of JCARH125 CAR T cells in the blood as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.

Analysis population: All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest

Groups in this outcome

Phase 1 50 x 10^6 Cells

JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 150 x 10^6 Cells

JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 300 x 10^6 Cells

JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 450 x 10^6 Cells

JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 600 x 10^6 Cells

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells

Phase 1 Anakinra 600 x 10^6 Cells

2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells

Phase 2 600 x 10^6 Cells

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion

Phase 2a 600 x 10^6 Cells Anti-BCMA

JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy

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
Phase 1 50 x 10^6 Cells	13
Phase 1 150 x 10^6 Cells	30
Phase 1 300 x 10^6 Cells	26
Phase 1 450 x 10^6 Cells	20
Phase 1 600 x 10^6 Cells	20
Phase 1 Anakinra 600 x 10^6 Cells	13
Phase 2 600 x 10^6 Cells	23
Phase 2a 600 x 10^6 Cells Anti-BCMA	10

Reported measurements

Source class 1

Values in Day*copies/UG · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Phase 1 50 x 10^6 Cells	556080.86	288.83	Not reported	Not reported	Not reported
Phase 1 150 x 10^6 Cells	610142.64	276.50	Not reported	Not reported	Not reported
Phase 1 300 x 10^6 Cells	1307054.13	159.86	Not reported	Not reported	Not reported
Phase 1 450 x 10^6 Cells	1390556.32	188.93	Not reported	Not reported	Not reported
Phase 1 600 x 10^6 Cells	1956613.78	80.39	Not reported	Not reported	Not reported
Phase 1 Anakinra 600 x 10^6 Cells	2052280.38	104.12	Not reported	Not reported	Not reported
Phase 2 600 x 10^6 Cells	1427277.29	226.53	Not reported	Not reported	Not reported
Phase 2a 600 x 10^6 Cells Anti-BCMA	1287032.03	145.22	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
288.83
value
556080.86
group Id
OG001
spread
276.50
value
610142.64
group Id
OG002
spread
159.86
value
1307054.13
group Id
OG003
spread
188.93
value
1390556.32
group Id
OG004
spread
80.39
value
1956613.78
group Id
OG005
spread
104.12
value
2052280.38
group Id
OG006
spread
226.53
value
1427277.29
group Id
OG007
spread
145.22
value
1287032.03

denoms

counts
group Id
OG000
value
13
group Id
OG001
value
30
group Id
OG002
value
26
group Id
OG003
value
20
group Id
OG004
value
20
group Id
OG005
value
13
group Id
OG006
value
23
group Id
OG007
value
10
units
Participants

description

AUC (0-28) of JCARH125 CAR T cells in the blood as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.

dispersion Type

Geometric Coefficient of Variation

groups

description
JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
id
OG000
title
Phase 1 50 x 10^6 Cells
description
JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
id
OG001
title
Phase 1 150 x 10^6 Cells
description
JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
id
OG002
title
Phase 1 300 x 10^6 Cells
description
JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
id
OG003
title
Phase 1 450 x 10^6 Cells
description
JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
id
OG004
title
Phase 1 600 x 10^6 Cells
description
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
id
OG005
title
Phase 1 Anakinra 600 x 10^6 Cells
description
JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
id
OG006
title
Phase 2 600 x 10^6 Cells
description
JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
id
OG007
title
Phase 2a 600 x 10^6 Cells Anti-BCMA

param Type

GEOMETRIC_MEAN

population Description

All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest

reporting Status

POSTED

time Frame

From JCARH125 infusion through 28 days after the infusion

title

Area Under the Concertation-Time Curve (AUC) From Time Day 1 to Day 29 [AUC (0-28 Days)]

type

SECONDARY

unit Of Measure

Day*copies/UG

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice