Autologous T Cells Expressing Enhanced TCRs Specific for MAGEA3/A6/B18 or NYESO-1/LAGE in Patients With Ovarian Cancer
This study has been withdrawn prior to enrollment.
(Site decided to withdraw participation.)
Sponsor:
University of Pennsylvania
Collaborators:
Roswell Park Cancer Institute
Adaptimmune
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01567891
First received: March 16, 2012
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
This study, will take a subject's "T cells" and "teach" them to be able to recognize and attack the ovarian cancer cells. This is done by putting in a gene or genetic material that will change how a subject's T cells work and hopefully get them to attack and kill ovarian cancer cells. These new T cells are called "engineered T cells" because the new gene is causing them to become directed toward the ovarian cancer cells rather than their usual targets. These are also called "gene-modified T cells". For subjects who have the HLA A1 tissue-type marker, T cells would be engineered to recognize a substance on the ovarian cancer cells called "MAGE A3/A6/B18". For subjects who have the HLA A2 tissue-type marker, the T cells would be engineered to recognize a substance called "NY ESO 1/LAGE". After putting this new gene in T cells (a procedure called "gene therapy") the investigators will grow the cells in the laboratory and give these cells back to subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer |
Biological: T cells |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/IIa, Open Label, Dual Cohort, Triple Center Clinical Trial Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs Specific for MAGE-A3/A6/B18 or NYESO-1/LAGE in Patients With Recurrent or Treatment Refractory Ovarian Cancer |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3 [ Time Frame: Month: 9 ] [ Designated as safety issue: Yes ]This will evaluate safety of autologous genetically modified T cells transduced to express the high affinity MAGE-A3a3a TCR in HLA-A101 subjects, and the high affinity NY-ESO-1c259 TCR in HLA-A201 subjects.
Secondary Outcome Measures:
- Tumor Measurements [ Time Frame: Month 9 ] [ Designated as safety issue: No ]To measure the effect of MAGE-A3a3a-T and NY-ESO-1c259-T on tumor as measured by Immune-related Response Criteria and progression free survival
| Enrollment: | 0 |
| Study Start Date: | February 2012 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cohort 1
Subjects who are HLA A101 positive and their tumor expresses MAGE-A3/MAGE-A6/MAGE- B18 positive.
|
Biological: T cells
Subjects who are HLA A101 positive and their tumor expresses MAGE-A3/MAGE-A6/MAGE- B18 positive will undergo apheresis, T cell infusion and frequent follow up for 9 months. Subjects will then undergo long term follow up for up to 15 years.
|
|
Experimental: Cohort 2
Subjects who are HLA A201 positive and their tumor expresses NY-ESO-1 and/or LAGE positive.
|
Biological: T cells
Subjects who are HLA A201 positive and their tumor expresses NY-ESO-1 and/or LAGE positive will undergo apheresis, T cell infusion and frequent follow up for 9 months. Subjects will then undergo long term follow up for up to 15 years.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have a diagnosis of recurrent epithelial ovarian, primary peritoneal or fallopian tube carcinoma with refractory or platinum resistant disease and/or have received ≥ 2 lines of chemotherapy.
- Measurable disease as defined by RECIST Criteria (V1.1)
- HLA-A201 and tumor express NY-ESO-1 and/or LAGE or HLA-A101 then the tumor must express MAGE-A3 and/or MAGE-A6 and/or MAGE-B18.
- Last chemotherapy, radiotherapy or immunotherapy, or prior investigational agents was longer than 4 weeks prior to study entry.
- Normal organ and bone marrow function (ANC ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Creatinine ≤ 2.0 mg/dL; AST/ALT ≤ 2.5 x ULN; Total Bilirubin WNL; Leucocytes ≥ 3,000/mcL)
- Life expectancy of greater than 4 months; ECOG PS of 0 or 1
Exclusion Criteria:
- Pregnant
- Active brain metastases
- Active HIV, Hepatitis B, Hepatitis C infection
- Received an experimental vaccine within 6 months
- Received any previous gene therapy using an integrating vector
- Allergy to Cyclophosphamide, Mesna
- Prior malignancy within the past 3 years (except non-melanoma skin cancer)
- Active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
- Chronic use of the following within 30 days prior to study entry: corticosteroids, hydroxyurea or immunomodulating agents (interleukin-2, interferon-alpha, interferon gamma, granulocyte colony stimulating factors (inhaled steroids OK)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01567891
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
Sponsors and Collaborators
University of Pennsylvania
Roswell Park Cancer Institute
Adaptimmune
Investigators
| Study Chair: | Kunle Odunsi, MD, PhD | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01567891 History of Changes |
| Other Study ID Numbers: | 16811, 206611 |
| Study First Received: | March 16, 2012 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pennsylvania:
|
Ovarian Cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 22, 2013