| Eligibility |
Key Inclusion Criteria:
- Demonstrated CD20 expression and one of the following disease subtypes: CLL/small
lymphocytic lymphoma (SLL); indolent NHL (marginal zone lymphoma and follicular
lymphoma Grades 1-3A); or aggressive NHL (follicular lymphoma Grade 3B+, mantle cell
lymphoma, nodular lymphocyte-predominant Hodgkin lymphoma, DLBCL, HGBCL, transformed
follicular lymphoma, Richter transformation, or other CD20+ aggressive non-Hodgkin
large cell lymphoma)
- At least 2 prior lines of therapy and without treatment options that are recognized to
offer clinical benefit
- Adequate marrow reserve, renal function, and hepatic function
- Measurable disease defined as = 1 bi-dimensionally measurable nodal lesion of > 1.5 cm
in the longest dimension for subjects with PET avid disease for subtypes with nodular
disease or at least one bi-dimensionally measurable extranodal lesion, defined as >
1.0 cm in its longest dimension
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Life expectancy of = 12 weeks
- Use of a highly effective contraceptive measure all males and all females of
childbearing potential during study through 180 days post last dose; Females of
childbearing potential need to have a negative serum pregnancy test within 7 days
prior to first dose.
- Tumor tissue block or 3 to 5 unstained slides from lymph node or other relevant biopsy
collected in the past 6 months or subject must be willing to provide a baseline
biopsy, unless not safely accessible
- In subjects with prior CAR-T therapy, >90 days post CAR-T at day of first dosing
Key Exclusion Criteria:
- Burkitt's or Burkitt's like lymphoma or lymphoplastic lymphoma
- Current or past history of central nervous system (CNS) lymphoma
- Prior allogeneic stem cell transplantation except for those with FL and MCL, who are
excluded if transplant occurred less than 100 days prior to Screening or if they
exhibit active signs of or received treatment for graft versus host disease (GvHD)
- Prior solid organ transplantation
- Autologous stem cell transplantation = 100 days
- History of autoimmune disease, including but not limited to myasthenia gravis,
myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis associated with antiphospholipid
syndrome, Wegener's granulamatosis, Sjorgen's syndrome, Guillain-Barre-syndrome,
multiple sclerosis vasculitis, or glomerulonephritis (subjects with a remote history
of, or well-controlled autoimmune disease, may be eligible)
- Major surgery in the last 28 days prior to dosing
- Evidence of significant, uncontrolled concomitant disease that could affect compliance
with study
- Current or past history of CNS disease (Subjects with remote history of non-lymphoma
CNS disease and with no residual neurologic deficits may be eligible to enroll)
- QT interval corrected by Fridericia's formula (QTcF) > 480 msec
- Significant cardiovascular disease
- Received systemic therapy with anti-cancer therapies 4 weeks prior to first DR-0201
administration or 5 half-lives of the drug, whatever is shorter. Treatment with
corticosteroid = 25mg/day prednisone or equivalent is allowed. Inhaled and topical
steroids are allowed.
- Prior treatment with systemic immunotherapy agents included, but not limited to radio
immunoconjugates, antibody drug conjugates, cytokines, immune checkpoint inhibitors 4
weeks or 5 half-lives of the drug, whatever is shorter
- Positive hepatitis B virus (HBV) polymerase chain reaction (PCR) test. Subjects with a
positive serologic test for HBV (i.e., positive hepatitis B core antibody [HBcAb] and
negative for hepatitis B surface antigen [HBsAg]) must have a negative PCR test
- Known infection with HIV, HBV, or hepatitis C virus (HCV). Subjects who are
HIV-positive with undetectable HIV RNA and at least 3 months on a highly effective
antiviral therapy (HART) and subjects who are HCV-positive who have completed at least
1 month of highly effective antiviral therapy may be eligible.
- Acute bacterial, viral, or fungal infection at baseline
- Active infection requiring systemic (IV) treatment with antimicrobial, antifungal, or
antiviral agents in the 2 weeks prior to dosing.
- Administration of a live, attenuated vaccine within 4 weeks prior to first DR-0201
administration or anticipation that such vaccine administration would be necessary
during the course of the study
- Another invasive malignancy in the last 2 years (except basal cell carcinoma and
tumors deemed by the investigator to be of low likelihood for recurrence)
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