NCT01583686 · OUTCOME

Number of Patients With Objective Tumor Regression

CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer · Source last updated 2019-10-14

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 3.5 mos.

What was measured

Objective tumor regression response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Groups in this outcome

Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2

1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin

Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2

Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2

Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2

Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2

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
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2	3
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2	3
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2	3
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2	3
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2	3

Reported measurements

Source class 1

Complete Response

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2	Not reported	Not reported	Not reported	Not reported
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2	Not reported	Not reported	Not reported	Not reported
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2	Not reported	Not reported	Not reported	Not reported
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2	Not reported	Not reported	Not reported	Not reported
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
Group	Spread	Lower	Upper	Comment
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2	Not reported	Not reported	Not reported	Not reported
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2	Not reported	Not reported	Not reported	Not reported
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2	Not reported	Not reported	Not reported	Not reported
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2	Not reported	Not reported	Not reported	Not reported
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2	Not reported	Not reported	Not reported	Not reported

Stable Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2	0	Not reported	Not reported	Not reported	Not reported
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2	1	Not reported	Not reported	Not reported	Not reported
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2	0	Not reported	Not reported	Not reported	Not reported
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2	0	Not reported	Not reported	Not reported	Not reported
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2	0	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2	3	Not reported	Not reported	Not reported	Not reported
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2	2	Not reported	Not reported	Not reported	Not reported
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2	3	Not reported	Not reported	Not reported	Not reported
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2	3	Not reported	Not reported	Not reported	Not reported
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2	3	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Complete Response
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Partial Response
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Stable Disease
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
3
title
Progressive Disease

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
3
units
Participants

description

groups

description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
OG000
title
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
OG001
title
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
OG002
title
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
OG003
title
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
description
1/Phase I: Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days. Other Names: •Fludara Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL) Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes. Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr. Other Names: •Cytoxan Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses). Other Names: •Proleukin
id
OG004
title
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

3.5 mos.

title

Number of Patients With Objective Tumor Regression

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice