Must not have received alemtuzumab or other anti-T-cell antibody therapy within 28 days of entry onto this study
Prior therapy with an anti-CSF1R antibody
Prior severe reaction to treatment with a human antibody that cannot be managed with standard supportive measures.
Prior treatment with an antiPD1, antiPDL1, antiPDL2, antiCD137, or antiCTLA4 antibody, or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways.
Have received treatment with a therapeutic antibody less than 4 weeks before the first dose of AG-270. A minimum 2-week period between the last treatment with a therapeutic antibody and the first dose of AG-270 may be permitted in subjects with rapidly progressive or aggressive subtypes of lymphoma following discussion with the medical monitor.
Phase II only: Subjects must have presence of peripheral blood levels of IgG anti-?-glucan antibody (ABA) of ? 20 ?g/mL as determined by an ELISA test within 90 days prior to study registration.
Have baseline anti-vaccinia antibody titers < 10
Prior anti-human antibody response (anti-heart antibodies [AHA] or anti-drug antibody [ADA])
Must have anti-measles immunity as demonstrated by serum immunoglobulin (Ig)G anti-measles antibody levels of >= 1.1 EU/ml as determined by BioPlex Measles IgG multiplex flow immunoassay
Inclusion of participants with confirmed positive serology of at least one auto-antibody panel (anti-nuclear antibody, anti-double stranded DNA, cytoplasmic anti-neutrophil cytoplasmic antibody, and perinuclear anti-neutrophil cytoplasmic antibody) at screening should be discussed between Sponsor and investigators, and if judged clinically relevant could be referred to a specialist (Rheumatologist) to exclude an underlying auto-immune disease
Prior treatment with an anti-CTLA-4 antibody treatment; the course of sipuleucel-T therapy (i.e. three treatments) leading up to this investigational trial must be the first course of therapy these patients have received
Patients that have undergone treatment with anti-CTLA-4 (Cytotoxic T-Lymphocyte Antigen 4) antibody must have at least 3 months from last dose of CTLA-4 antibody before they can be enrolled into this study
Human anti-mouse antibody (HAMA) levels of > 100 ug/ml or human ricin antibodies (HARA) > 100 ug/ml HARA after cycle 1
Received treatment with anti-CTLA-4 antibody within 30 days prior to the start of CMP-001.
Have peripheral blood levels of IgG anti-?-glucan antibody (ABA) of ? 20 mcg/mL as determined by an ELISA test within 90 days prior to start of study treatment
Patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have human anti-human antibody (HAHA) antibody titer =< 1300 enzyme-linked immunosorbent assay (Elisa) units/ml; human anti-mouse antibody positivity is allowed
LYMPHODEPLETION: Subjects who have received prior therapy with murine antibodies must have documentation of absence of human anti-mouse antibodies (HAMA) prior to lymphodepletion on this study
Negative human anti-murine antibody (HAMA) test.
Prior treatment with murine and hu3F8 is allowed; patients with prior humanizing murine IgG3 anti-GD2 antibody m3F8 (m3F8), hu3F8, ch14.18 or hu14.18 treatment must have human anti-human antibody (HAHA) antibody titer < 1300 enzyme-linked immunosorbent assay (ELISA) units/ml; human anti-mouse antibody positivity is allowed
PHASE I: Patients who have previously received anti-cytotoxic T-lymphocyte antigen (CTLA)-4 antibody therapy
Prior treatment with an anti-ErbB3 antibody
Prior treatment with other anti-GD2 antibodies is allowed (prior treatment with hu3F8 is NOT allowed), but human anti-human antibody (HAHA) antibody titer must be =< 1300 enzyme-linked immunosorbent assay (ELISA) units/mL
Absence of human anti?mouse monoclonal antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)
ELIGIBILITY CRITERIA- LYMPHODEPLETION/INFUSION OF tvs-CTL: Patients who have received prior therapy with murine antibodies must have documentation of absence of human anti-mouse antibodies (HAMA) prior to enrollment on this study
Presence of antibody against basiliximab in serum (only required for patients who have received prior antibody)
Human anti-mouse antibody (HAMA) titer > 1000 enzyme-linked immunosorbent assay (Elisa) units/ml
Prior treatment with murine and humanized 3F8 is allowed; patients with prior m3F8, hu3F8, ch14.18 or hu14.18 treatment must have human anti-human antibody (HAHA) antibody titer =< 1300 enzyme-linked immunosorbent assay (Elisa) units/ml; human anti-mouse antibody positivity is allowed
Human anti-hu3F8 antibody (HAHA) titer > 1300 Elisa units/ml
Presence of antibody against basiliximab (only required for patients who have received prior antibody)
Prior treatment with murine 3F8 is allowed; patients with prior m3F8, chimeric (ch)14.18 or hu14.18 treatment must have human anti-hu3F8 antibody (HAHA) antibody titer less than the upper limit of normal (defined as mean + 3*standard deviation [SD] of normal volunteers)
Patients previously treated with murine monoclonal antibodies will be excluded if they have a human anti-murine antibody (HAMA) level of > 1000 U/ml
Patients with a history of having to discontinue anti-GD2 antibody therapy due to toxicity are not eligible.
Negative human anti-mouse antibody (HAMA) result.
Anti-measles virus immunity as demonstrated by IgG anti-measles antibody per institutional guidelines (within 21 days prior to study registration)
Has received study therapy (including investigational device) as part of a clinical trial within 4 weeks of the first dose of treatment, with the exclusion of an anti-PD1/L1 antibody given as either a single agent or non-CTLA-4 antibody containing combination
Anti-measles immunity as demonstrated by serum immunoglobulin (Ig)G anti-measles antibody levels of >= 1.1 EU/ml as determined by BioPlex Measles IgG multiplex flow immunoassay
Anti-measles virus immunity as demonstrated by immunoglobulin G (IgG) anti-measles antibody levels of >= 1.1 EU/ml as determined by enzyme immunoassay
Patients with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte antigen 4 (CTLA 4) antibody
Study participants with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte antigen 4 (CTLA 4) antibody and/or anti-PD-1 antibody
Patients with known immunodeficiency disorder, or presumed to be unable to respond to anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA 4) monoclonal antibody (mAb)
Absence of human anti-mouse antibodies (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies
Patients with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA 4) antibody
Circulating human anti-mouse antibody (HAMA), to be determined before each infusion
History of prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) blocking antibody
Patients with serum human anti-human antibody (HAHA) against daclizumab
Prior therapy with an anti-PD-1, anti-programmed death-ligand (PD-L)1, anti-PDL-2, or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) antibody (or any other antibody targeting T cell co-stimulation pathways)\r\n* In the fourth cohort at 3 mg/kg of BMS-936558, ten patients will be accrued that have had prior anti-CTLA-4 antibody at 3 or 10 mg/kg, and have not had any dose limiting immune-related adverse events (irAE) as defined in this protocol, i.e. none, or grades 1 or 2 non-dose limiting toxicity\r\n* In an additional fifth cohort, also at 3 mg/kg of BMS-936558, twenty patients will be accrued that have had prior anti-CTLA-4 antibody at 3 or 10 mg/kg, and may have had a dose limiting irAE of grades 3 or 4 as defined in this protocol\r\n* After amendment 9, grade 4 hepatotoxicity, skin toxicity or pancreatic enzyme elevations that did not require infliximab, mycophenolic acid, or any immune suppressive treatment beyond steroids will be allowed; those who experienced grade 4 colitis, hypophysitis, neurologic changes or any other grade 4 side effect other than liver, pancreatic or skin related will still be excluded from this cohort; after amendment 12, those with grades 3-4 side effects that required treatment with any immune suppressive in addition to steroids will be allowed in cohort 5; those with grade 4 side effects other than GI, endocrine, skin, liver and pancreatic will still be excluded from entry to cohort 5\r\n* In the sixth cohort at 3 mg/kg of BMS-936558, an extension cohort of sixty patients will be accrued that have had prior anti-CTLA-4 antibody at 3 or 10 mg/kg, and have not had any dose limiting irAE as defined in this protocol, i.e. they would have had none, or grade 1 or grade 2 non-dose limiting toxicity from ipilimumab\r\n* Within cohort 6, up to ten patients may be included that have four or fewer untreated brain metastases, with no lesion larger than 2 cm, and no evidence of cerebral edema requiring steroids
Circulating human anti-mouse antibody (HAMA), to be determined before each infusion
No CVA21 neutralising antibody (? 1:16)
Have a history of hypersensitivity to human or mouse antibody products.
No history of known human anti-chimeric antibody (HACA) positivity; this does not have to be checked prior to enrollment unless clinically indicated
Prior therapy with an anti-cytotoxic T-lymphocyte antigen 4 (CTLA4) antibody or an histone deacetylases (HDAC) inhibitor
Circulating human anti-mouse antibody (HAMA), to be determined before each infusion
Circulating antibody against mouse immunoglobulin (HAMA)
Received alemtuzumab or other anti-Tcell antibody within 28 days
Human anti-mouse antibody (HAMA) titer < 1000 enzyme-linked immunosorbent assay (Elisa) units/ml if applicable
HAMA titer > 1000 Elisa units/ml
Prior treatment with murine 3F8 is allowed; patients with prior m3F8, hu3F8, monoclonal antibody ch14.18 (ch14.18) or hu14.18 monoclonal antibody (hu14.18) treatment must have human anti-hu3F8 antibody (HAHA) titer =< 1300 enzyme-linked immunosorbent assay (ELISA) units/ml
Allergy to murine products or positive human anti-mouse antibody (HAMA)
Previous treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody or cancer vaccine
Circulating human anti-mouse antibody (HAMA)
Patients with positive antinuclear antibody (ANA) and/or anti-double strand (ds) DNA antibodies
Have peripheral blood levels of IgG anti-?-glucan antibody (ABA) of ? 20 mcg/mL as determined by an ELISA test within 28 days prior to start of study treatment
Circulating antibody against mouse immunoglobulin (HAMA)
Measles antibody titer on the BioRad Multiplex assay less than or equal to 1.0
History of treatment with a murine-derived biological product other than blinatumomab unless subject has been shown to be negative for human-anti-mouse-antibodies (HAMA) prior to or during screening
Prior treatment with an anti-4-1BB antibody
Has no known allergy to murine products or positive human anti-mouse antibody (HAMA)
For patients if they have a history of colitis or diarrhea during anti-CTLA4 monoclonal antibody therapy, it is recommended that they have a formal evaluation by a gastroenterologist and a colonoscopy/endoscopy should be considered to demonstrate the absence of active bowel inflammation before initiating IL-2 therapy on this protocol
Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody
Patients with known immune impairment who may be unable to respond to anti-cytotoxic T-lymphocyte antigen 4 (CTLA 4) antibody
Previously treated with an anti-Dickkopf-1 (anti-DKK-1) or antibody therapy, or have had a significant allergy to a known pharmaceutical therapy that, in the opinion of the Investigator, poses an increased risk to the patient
Donor must be HIV-1&2 antibody and HTLV-1&2 antibody sero-negative by FDA licensed test.
Recipient must be HIV-1&2 antibody and HTLV-1&2 antibody sero-negative by FDA licensed test.
For patients who have received prior anti-cytotoxic T-lymphocyte antigen (CTLA)4 monoclonal antibody therapy (ipilimumab or tremelimumab), there is a risk of bowel perforation with IL-2 therapy; therefore, for these patients if they have a history of colitis or diarrhea during anti-CTLA4 monoclonal antibody therapy, they should have a formal evaluation by a gastroenterologist and a colonoscopy should be considered to demonstrate the absence of active bowel inflammation before initiating IL-2 therapy on this protocol
Patients must not have received prior anti-disialoganglioside (GD2) antibody therapy
ANTIBODY PROPHYLAXIS:
Patients with known lupus anticoagulant or positive antiphospholipid antibody
Positive antinuclear antibody (ANA) result
Prior treatment with anti-GD2 monoclonal antibody is permitted only if human anti-human antibody titer is =< 1300 assay developed by Dr. Nai-Kong Cheung
Prior development of positive human anti-mouse antibody response (HAMA) or human anti-human antibody response (HAHA)
Positive human anti-hu3F8 antibody titer
Any patient who has had exposure to mouse or chimeric (human/mouse) immunoglobulin and has antibody to the M5A
Prior treatment with an anti-HER3 antibody
Received treatment with anti-CTLA-4 antibody within 30 days prior to the start of CMP-001 dosing on W1D1.