NCT01583686 · STUDY IN CONTEXT

CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

→

primary · POSTED

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-cervical-cancer-jobevne-5a0678d2
nct id: NCT01583686
trial label: CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 2
harms Count: 5
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0000
source section id
NCT01583686-om-0000
source outcome index
0
endpoint
Number of Patients With Objective Tumor Regression
endpoint definition
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.
time origin
3.5 mos.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0001
source section id
NCT01583686-om-0001
source outcome index
1
endpoint
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
endpoint definition
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
time origin
Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0000
arm key
OG000
arm label
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0000
arm key
OG001
arm label
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0000
arm key
OG002
arm label
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0000
arm key
OG003
arm label
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0000
arm key
OG004
arm label
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0001
arm key
OG000
arm label
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0001
arm key
OG001
arm label
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0001
arm key
OG002
arm label
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0001
arm key
OG003
arm label
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
outcome key
om-0001
arm key
OG004
arm label
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
regimen
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
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01583686-om-0001#groups/OG004

harms

release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
harm key
EG000
source section id
NCT01583686-ae
event group key
EG000
event group label
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
harm key
EG001
source section id
NCT01583686-ae
event group key
EG001
event group label
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
harm key
EG002
source section id
NCT01583686-ae
event group key
EG002
event group label
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
serious affected
0
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
harm key
EG003
source section id
NCT01583686-ae
event group key
EG003
event group label
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
serious affected
1
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-cervical-cancer-jobevne-5a0678d2
nct id
NCT01583686
harm key
EG004
source section id
NCT01583686-ae
event group key
EG004
event group label
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
serious affected
2
serious at risk
3
other affected
3
other at risk
3
frequency threshold
0
collection period
Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice