Phase
Condition
Lymphoproliferative Disorders
Leukemia
Mycosis Fungoides
Treatment
DR-01
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria (All Subjects):
≥18 years of age.
Able to understand and comply with protocol-required study procedures andvoluntarily sign a written informed consent document.
Sufficient key organ performance and coagulation.
Female subjects of childbearing potential (postmenarcheal, has an intact uterus andat least one ovary, and is <1 year postmenopausal) must agree to use a highlyeffective method of contraception from enrollment through at least 12 months afterlast dose of DR-01.
Male subjects must agree to use acceptable effective method(s) of contraception. Subjects with LGLL must also meet inclusion criteria 6 and 7.
Must have discontinued at least one prior line of systemic therapy.
Additional immunophenotypic criteria must be met. Disease-specific Inclusion Criteria (Cytotoxic Lymphomas): Subjects with cytotoxic lymphomas must also meet inclusion criteria 8,9, and 10.
Subjects must have failed at least two prior systemic regimens.
Availability of post-progression tissue sample or willingness to consent to abaseline biopsy.
Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification [Swerdlow 2016]).
For Part A only, evaluable disease is acceptable.
For Part B2 only:
Subjects must have radiographically measurable disease to be assessed by Lugano criteria. Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or leukemic involvement that can be evaluated using a modified TPLL response criteria (Staber 2019).
Subjects with hepatosplenic disease or other variants that do not have measurable disease by Lugano criteria (Cheson 2014) may be eligible upon discussion with the Medical Monitor if they have identifiable leukemic involvement in BM or peripheral blood (meeting the CD8+ cytotoxic phenotype definition) that can be evaluated for response using a modified TPLL response criteria (Staber 2019), or skin involvement that can be evaluated using Olsen criteria (Olsen 2021).
Exclusion
Exclusion Criteria:
Disease-specific Exclusion Criteria; LGLL and ANKL:
A reactive LGL lymphocytosis to a viral infection or LGL associated withmyelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The following exclusion criteria apply to all subjects:
Active systemic infection or severe localized infection requiring systemicantibiotics, antivirals or antifungals.
Active or suspected malignant central nervous system involvement.
Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding,pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).
Active known second malignancy.
Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).
Hepatitis B infection (hepatitis B virus surface antigen [HBsAg] positive), orhepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleicacid). Subjects with HCV with undetectable virus after treatment are eligible.
History of clinically significant cardiac disease or congestive heart failuregreater than New York Heart Association (NYHA) Class II.
Use of systemic corticosteroids (e.g., >5 mg/day prednisone or equivalent forsubjects with LGL leukemia (subjects on 20 mg prednisone or equivalent to treat LGLleukemia must be weaned within 28 days post C1D1 to 5 mg) and >10 mg/day prednisoneor equivalent for subjects with cytotoxic lymphoma) within 15 days (except forprophylaxis for radiodiagnostic contrast reactions), or other non-biologicalimmunosuppressive drugs within 15 days, prior to C1D1. Patients on stable prednisone ≤10 mg for documented rheumatologic/autoimmune conditions are exempted from thisrequirement.
Any condition requiring hormonal therapy (except for contraception, hormonereplacement therapy and hormonal prophylaxis for a prior malignancy).
Any other medical or psychiatric condition, or laboratory abnormality that wouldincrease the risk associated with study participation, in the opinion of theInvestigator or Medical Monitor.
Toxicities from previous anticancer therapies must have resolved to baseline levelsor to Grade 1 (except for alopecia, peripheral neuropathy, or hematologic parametersmeeting inclusion criteria).
Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days
Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.
Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexusblockade).
Study Design
Connect with a study center
Dren Investigational Site
Clayton, Victoria 3168
AustraliaActive - Recruiting
Dren Investigational Site
East Melbourne, Victoria 3002
AustraliaSite Not Available
Dren Investigational Site
Richmond, Victoria 3121
AustraliaActive - Recruiting
Dren Investigational Site
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Dren Investigational Site
Pierre-Bénite, 69310
FranceActive - Recruiting
Dren Investigational Site
Rennes, 35000
FranceActive - Recruiting
Dren Investigational Site
Toulouse, 31059
FranceActive - Recruiting
Dren Investigational Site
Berlin, 10117
GermanyActive - Recruiting
Dren Investigational Site
Cologne, 50937
GermanySite Not Available
Dren Investigational Site
Leipzig, 04103
GermanyActive - Recruiting
Dren Investigational Site 1
Hong Kong,
Hong KongActive - Recruiting
Dren Investigational Site 2
Hong Kong,
Hong KongActive - Recruiting
Dren Investigational Site
Bologna, 40126
ItalyActive - Recruiting
Dren Investigational Site 1
Busan,
Korea, Republic ofActive - Recruiting
Dren Investigational Site 2
Busan,
Korea, Republic ofActive - Recruiting
Dren Investigational Site
Goyang-si,
Korea, Republic ofActive - Recruiting
Dren Investigational Site 1
Seoul,
Korea, Republic ofActive - Recruiting
Dren Investigational Site 2
Seoul,
Korea, Republic ofActive - Recruiting
Dren Investigational Site 3
Seoul,
Korea, Republic ofActive - Recruiting
Dren Investigational Site
Barcelona, 08035
SpainActive - Recruiting
Dren Investigational Site
Salamanca, 37007
SpainActive - Recruiting
Dren Investigational Site
Tainan,
TaiwanActive - Recruiting
Dren Investigational Site
Taipei,
TaiwanActive - Recruiting
Dren Investigational Site
Birmingham, Alabama 35233
United StatesActive - Recruiting
Dren Investigational Site
Phoenix, Arizona 85054
United StatesSite Not Available
Dren Investigational Site
Duarte, California 91010
United StatesActive - Recruiting
Dren Investigational Site
Redwood City, California 94063
United StatesActive - Recruiting
Dren Investigational Site
New Haven, Connecticut 06519
United StatesSite Not Available
Dren Investigational Site
Jacksonville, Florida 32224
United StatesSite Not Available
Dren Investigational Site
Rochester, Minnesota 55905
United StatesSite Not Available
Dren Investigational Site
New York, New York 10021
United StatesActive - Recruiting
Dren Investigational Site 1
New York, New York 10021
United StatesActive - Recruiting
Dren Investigational Site 2
New York, New York 10032
United StatesSite Not Available
Dren Investigational Site
Cleveland, Ohio 44106
United StatesSite Not Available
Dren Investigational Site
Columbus, Ohio 43210
United StatesActive - Recruiting
Dren Investigational Site
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Dren Investigational Site 1
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Dren Investigational Site 2
Pittsburg, Pennsylvania 15213
United StatesActive - Recruiting
Dren Investigational Site 2
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Dren Investigational Site
Houston, Texas 77030
United StatesActive - Recruiting
Dren Investigational Site
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Dren Investigational Site
Fairfax, Virginia 22031
United StatesActive - Recruiting
Dren Investigational Site
Seattle, Washington 98109
United StatesActive - Recruiting
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