Adults 18 to 70, any sex, with Cervical Cancer or Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Objective Tumor RegressionPrimary· 3.5 mos.
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 le
Group
Value
95% CI
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
0
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
0
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
0
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
0
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
0
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
0
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
0
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
0
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
0
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
0
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
0
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
1
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
0
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
0
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
0
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
3
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
2
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
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)Primary· 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.
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 o
Group
Value
95% CI
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
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with metastatic cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patients white blood cells with a retrovirus that has the gene for anti-mesothelin incorporated in the retrovirus.
Objective:
The purpose of this study is to determine a safe number of these cells to infuse and to see if these tumor fighting cells (anti-mesothelin cells) cause metastatic cancer tumors to shrink.
Eligibility:
\- Adults age 18-70 with metastatic cancer expressing the mesothelin molecule.
Design:
Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed
Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-mesothelin cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.}
Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-mesothelin cells, and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.
Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 14 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01583686.