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Lead
Cogent Biosciences, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
signed written informed consent obtained prior to study procedures
histologically-confirmed relapsed or refractory CD20+ B-cell lymphoma of one of the following types, with documented disease progression or recurrence following the immediate prior therapy: DLBCL (regardless of cell of origin or underlying molecular genetics), MCL, PMBCL, Gr3b-FL, TH-FL (prior dx of FL before transforming to DLBCL).
biopsy-confirmed CD20+ expression of the underlying malignancy with disease progression following immediate prior therapy
at least 1 measurable lesion on imaging.
must have received adequate prior therapy for the underlying CD20+ B-cell lymphoma, defined as an anti-CD20 mAb in combination with an anthracycline-containing chemotherapy regimen (i.e. chemo-immunotherapy) and at least one of the following:
* biopsy-proven refractory disease after frontline chemo-immunotherapy
* relapse within 1 year from frontline chemo-immunotherapy and ineligible for autologous hematopoietic stem cell transplant (auto-HSCT)
* for subjects with DLBCL, PMBCL, and Gr3b-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT
* for subjects with TH-FL: relapsed or refractory disease following at least 2 prior regimens or following an auto-HSCT. At least 1 prior regimen with an anti-CD20 mAb in combination with chemotherapy is required following documented transformation
* for subjects with MCL (confirmed with cyclin D1 expression or evidence of t(11;14) by cytogenetics, fluorescent in situ hybridization (FISH) or polymerase chain reaction (PCR): relapsed or refractory disease after at least 1 prior regimen with chemo-immunotherapy (prior auto-HSCT is allowable)
ECOG 0 or 1
life expectancy of at least 6 months
platelet count greater than 50,000/µL
You may not be if
known active central nervous system (CNS) involvement by malignancy.
prior treatment as follows:
* alemtuzumab within 6 months of enrollment
* fludarabine, cladribine, or clofarabine within 3 months of enrollment
* external beam radiation within 2 weeks of enrollment
* mAb (including rituximab) within 2 weeks of enrollment
* other lymphotoxic chemotherapy (including steroids except as below) within 2 weeks of enrollment
* experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy
clinically significant cardiac disease
clinically significant active infection
clinically significant CNS disorder
clinical history, prior diagnosis, or overt evidence of autoimmune disease
known bone marrow involvement due to underlying malignant disease, in dose-escalation phase only
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