Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
DR-0201
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
At least 2 prior lines of therapy and without treatment options that are recognizedto offer clinical benefit
Adequate marrow reserve, renal function, and hepatic function
Measurable disease defined as ≥ 1 bi-dimensionally measurable nodal lesion of > 1.5cm in the longest dimension for subjects with PET avid disease for subtypes withnodular 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 ofchildbearing potential during study through 180 days post last dose; Females ofchildbearing potential need to have a negative serum pregnancy test within 7 daysprior to first dose.
Tumor tissue block or 3 to 5 unstained slides from lymph node or other relevantbiopsy collected in the past 6 months or subject must be willing to provide abaseline biopsy, unless not safely accessible
In subjects with prior CAR-T therapy, >90 days post CAR-T at day of first dosing
Exclusion
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 areexcluded if transplant occurred less than 100 days prior to Screening or if theyexhibit 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 antiphospholipidsyndrome, Wegener's granulamatosis, Sjorgen's syndrome, Guillain-Barre-syndrome,multiple sclerosis vasculitis, or glomerulonephritis (subjects with a remote historyof, 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 affectcompliance with study
Current or past history of CNS disease (Subjects with remote history of non-lymphomaCNS 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-0201administration or 5 half-lives of the drug, whatever is shorter. Treatment withcorticosteroid ≤ 25mg/day prednisone or equivalent is allowed. Inhaled and topicalsteroids are allowed.
Prior treatment with systemic immunotherapy agents included, but not limited toradio immunoconjugates, antibody drug conjugates, cytokines, immune checkpointinhibitors 4 weeks or 5 half-lives of the drug, whatever is shorter
Positive hepatitis B virus (HBV) polymerase chain reaction (PCR) test. Subjects witha 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 areHIV-positive with undetectable HIV RNA and at least 3 months on a highly effectiveantiviral therapy (HART) and subjects who are HCV-positive who have completed atleast 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-0201administration or anticipation that such vaccine administration would be necessaryduring the course of the study
Another invasive malignancy in the last 2 years (except basal cell carcinoma andtumors deemed by the investigator to be of low likelihood for recurrence)
Study Design
Connect with a study center
Dren Investigational Site
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Dren Investigational Site
Douglas, Queensland 4814
AustraliaActive - Recruiting
Dren Investigational Site
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Dren Investigational Site
Richmond, Victoria
AustraliaActive - Recruiting
Dren Investigational Site
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Dren Investigational Site
Hong Kong,
Hong KongActive - Recruiting
Dren Investigational Site
Busan, 48108
Korea, Republic ofActive - Recruiting
Dren Investigational Site
Goyang-si, 10408
Korea, Republic ofActive - Recruiting
Dren Investigational Site
Seoul, 06351
Korea, Republic ofSite Not Available
Dren Investigational Site
Belgrade,
SerbiaActive - Recruiting
Dren Investigational Site
Kragujevac,
SerbiaActive - Recruiting
Dren Investigational Site
Niš,
SerbiaActive - Recruiting
Dren Investigational Site
Sremska Kamenica,
SerbiaActive - Recruiting
Dren Investigational Site
Kent Ridge, 119228
SingaporeActive - Recruiting
Dren Investigational Site 3
Kent Ridge, 119228
SingaporeActive - Recruiting
Dren Investigational Site
Novena, 308433
SingaporeSite Not Available
Dren Investigational Site 1
Novena, 308433
SingaporeSite Not Available
Dren Investigational Site 2
Novena, 308433
SingaporeSite Not Available
Dren Investigational Site 2
Seng, 308433
SingaporeActive - Recruiting
Dren Investigational Site
Chang Hua,
TaiwanActive - Recruiting
Dren Investigational Site
Kaohsiung, 833
TaiwanSite Not Available
Dren Investigational Site
Taipei, 100
TaiwanActive - Recruiting
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