A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas (NCT05475925) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas
United States200 participantsStarted 2022-07-13
Plain-language summary
This is a multicenter, first-in-human, Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in adult patients with large granular lymphocytic leukemia or cytotoxic lymphomas
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥18 years of age.
✓. Able to understand and comply with protocol-required study procedures and voluntarily sign a written informed consent document.
✓. Sufficient key organ performance and coagulation.
✓. Female subjects of childbearing potential (postmenarcheal, has an intact uterus and at least one ovary, and is \<1 year postmenopausal) must agree to use a highly effective method of contraception from enrollment through at least 12 months after last dose of DR-01.
✓. Male subjects must agree to use acceptable effective method(s) of contraception.
✓. Must have discontinued at least one prior line of systemic therapy.
✓. Additional immunophenotypic and symptomatic criteria must be met.
✓. Subjects must have failed at least one prior systemic regimens.
Exclusion criteria
✕. A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
✕. Active systemic infection or severe localized infection requiring systemic antibiotics, 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).
What they're measuring
1
Part A: Safety and Tolerability. To determine the incidence and severity of adverse events as assessed by CTCAE v5.0.
Timeframe: Up to 25 months
2
Part A: Safety and Tolerability. To determine the incidence and severity of dose limiting toxicities (DLTs) as defined by protocol specified DLT criteria.
Timeframe: During First 28 days (Cycle 1)
3
Part A: To determine potential pharmacologically optimized dose/regimen for DR-01 in LGL leukemia and cytotoxic lymphoma populations as determined using an integrated assessment of efficacy, safety, PK/PD, and exposure-response relationships.
Timeframe: Up to 6 months
4
Part B: Overall Response Rate (ORR), defined as the proportion of subjects with Complete Response (CR) or Partial Response (PR) based on disease-specific response criteria.
✕. 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), or hepatitis C (hepatitis C virus \[HCV\] antibody positive, confirmed by HCV ribonucleic acid). Subjects with HCV with undetectable virus after treatment are eligible.
✕. History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.