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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Ovarian Cancer

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3

Outcome Description:

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.

Outcome Time Frame:

Month: 9

Safety Issue:

Yes

Principal Investigator

Kunle Odunsi, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

16811

NCT ID:

NCT01567891

Start Date:

February 2012

Completion Date:

January 2019

Related Keywords:

  • Ovarian Cancer
  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263