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Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started2015-08
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-09-30
Primary completion pushed: 2026-08 → 2027-08
Completion pushed: 2026-08 → 2027-08
2026-07-31
Study Status v22
Re-verified, no change to tracked fields
2025-07-30
Study Status v21
Primary completion date2025-08→2026-08
Completion date2025-08→2026-08
2024-07-30
Study Status v20
Primary completion date2024-08→2025-08
Completion date2024-08→2025-08
2023-09-01
Study Status v19
Primary completion date2023-08→2024-08
Completion date2023-08→2024-08
Show 18 earlier versions
2022-09-01
Study Status v18
Primary completion date2022-08→2023-08
Completion date2022-08→2023-08
2022-02-07
Study Status v17
Re-verified, no change to tracked fields
2021-02-05
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v16
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2021-08→2022-08
Completion date2021-08→2022-08
Enrollment targetestimated 30→confirmed 18
Study sitesdetails revised at 1 of 1 site
2020-04-10
Study Status v15
Primary completion date2020-08→2021-08
Completion date2020-08→2021-08
2019-04-09
Study Status, Conditions, Study Design, Arms and Interventions, Outcome Measures v14
Primary completion date2019-08→2020-08
Completion date2019-08→2020-08
2018-10-10
2 amendments v12-v13
2 re-verifications since 2018-07-12, no change to tracked fields
2018-05-07
Study Status, Study Description, Arms and Interventions, Outcome Measures v11
InterventionsCyclophosphamide (Drug), Fludarabine (Drug), IP Catheter Insertion (Device), Infusion of 4H11-28z/fIL-12/EFGRt+ Genetically-modified T…→Cyclophosphamide (Drug), Fludarabine (Drug), IP Catheter Insertion (Device), Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T…
Study descriptionrevised
[...] uct will be thawed and used to generate the 4H11-28z/fIL-12/EFGRtEGFRt+ genetically-modified T cells. It is expected to take appro [...]
2018-03-27
Study Status v10
Re-verified, no change to tracked fields
2018-01-17
Study Status, Study Description, Arms and Interventions, Outcome Measures v9
Primary completion date2018-08→2019-08
Completion date2018-08→2019-08
InterventionsCyclophosphamide (Drug), IP Catheter Insertion (Device), Infusion of 4H11-28z/fIL-12/EFGRt+ Genetically-modified T cells (Genetic)…→Cyclophosphamide (Drug), Fludarabine (Drug), IP Catheter Insertion (Device), Infusion of 4H11-28z/fIL-12/EFGRt+ Genetically-modified T…
Study description+72 characters
[...] y 4-6 weeks to prepare the autologous CAR+ T cells. On day 1-3 patients in cohorts V will receive conditioning chemotherapy with cyclophosphamide 750 mg/m^2 or 300 mg/m2 cyclophosphamide concurrent with 25-30 mg/m2 fludarabine 2-47 days prior to the initial infusion of autologous CAR+T cell [...]
2017-09-05
Study Status v8
Re-verified, no change to tracked fields
2017-04-24
Study Status, Study Description, Arms and Interventions, Eligibility v7
Eligibility criteria+182 characters
[...] truction, or need for parenteral hydration and/or nutrition Any condition/anomaly which would interfere with appropriate placement of the IP catheter for study drug administration, including knownKnown or suspected extensive abdominal adhesions. Any of the foll [...] ejection fraction ≤20% Active autoimmune disease (excluding treatedautoimmune hypothyroidismthyroid disease on a stable thyroid regimen). Such conditions include but are not limited to systemic l [...] Crohn's disease and temporal arteritis. Known or suspected ovarianleptomeningeal cancerdisease; metastasispatients with metastases to the centr [...] [...]
Study description-2 characters
[...] e the autologous CAR+ T cells. On day 1 patients in cohorts II-V will receive conditioning chemotherapy with cyclophosphamide 750 mg/m2m^2 2-4 days prior to the initial infusion of autologous CAR+T [...]
2017-02-21
Study Identification, Study Status, Conditions, Outcome Measures, Contacts/Locations v6
Completion datenot stated→2018-08
Study sitescontacts updated at 1 of 1 site
Study title-51 characters
[...] the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ EpithelialSolid Ovarian, Fallopian Tube or Primary Peritoneal CancerTumors
2016-11-01
Study Status, Sponsor/Collaborators v5
Collaborators+75 characters
Stanford University Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
2016-10-28
Study Status v4
Re-verified, no change to tracked fields
2016-08-15
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v3
Eligibility criteria-128 characters
[...] nce of measurable recurrence, with RECIST measurable disease at the time of intervention consent Patient's carcinoma must express the MUC16ecto antigen dete [...] allowed to receive, but are not required to receive, up to 35 additional prior chemotherapy treatment regimens (including [...] rement, and must be discontinued at least one week prior to registrationT cell infusion. Continuation of hormone replacement therapy is permitted P [...] allowed to receive, but are not required to receive, up to 35 biologic/targeted therapies as part of their treatment regi [...] gent) in the 6 months prior to the T cell infusion (a [...]
Study sitescontacts updated at 1 of 1 site
2016-05-31
Study Status v2
Re-verified, no change to tracked fields
2015-11-25
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2015-07-13
Original filing
The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected called "modified T cells". In the screening part of this study the tumor was found to have a protein called MUC16. This protein is present on about 70% of ovarian cancers. The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard chemotherapy. We also want to find out what effects these modified T cells have on the patient and their cancer.
Trial Details
NCT Number NCT02498912
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Stanford University, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Conditions Solid Tumors
Enrollment 18 participants
Start Date 2015-08
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-29