Clinical Trial Details for Study "GCC 1056"

Official Title: Phase I/IIa dual-cohort, two-site, clinical trial evaluating the safety and activity of redirected autologous T cells expressing a high-affinity TCR specific for MAGE-A3/6 or NY-ESO-1 administered post-ASCT in patients with advanced myeloma
Investigator: Aaron P. Rapoport, M.D.
Summary: In this Phase I/IIa study patients with advanced myeloma and who are candidates for autologous stem cell transplants will be eligible. The purpose of the study is to evaluate the safety and tolerability of autologous genetically modified T cells transduced to express the high affinity MAGE-A3 TCR in HLA-A1 subjects, and the high affinity NYESO-1 TCR in HLA-A2 subjects.
Disease site: Multiple Myeloma,Stem Cell Transplant
Disease stage: Relapsed, progressed, or failed to respond after at least one prior course of therapy.
Condition: Advanced Multiple Myeloma
Intervention: Redirected autologous T cells expressing a high affinity TCR specific for MAGE-A3/6 or NY-ESO-1 post ASCT
Phase: I/IIa
Study number: GCC 1056
Eligibility*
(inclusion criteria)
    Patients must have a diagnosis of myeloma as per the protocol;patients must have measurable disease on study entry;Patients must be between ages 18-80 (inclusive);Patients should have adequate vital organ function as defined by the protocol; ECOG performance status 0-2; Prior to Lenalidomide maintenance phase, all study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®;Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test as per the protocol; HLA-A1 patients must have confirmed MAGE-A3, and/or /A6 and/or B18 expression on the marrow biopsy specimen and HLA-A2 patients must have confirmed expression of NY-ESO-1 and/or LAGE as per the protocol.
(exclusion criteria)
    Pregnant or nursing females; HIV or HTLV-1/2 seropositivity; Known history of myelodysplasia; Prior allogeneic transplant (prior autologous transplant is allowed); History of severe autoimmune disease requiring steroids or other immunosuppressive treatments; Active bacterial, viral or fungal infections; Active Hepatitis B as defined by the protocol; Evidence or history of other significant cardiac, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which would likely increase the risks of participating in the study. For any transplant patient over 60 and for patients with prior history of heart disease, a pre transplant cardiac stress test is recommended. The specific type of stress test will be selected at the PIs discretion.
Contact Person
 Sunita Philip, MS 410-328-8199
* Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823.


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