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 States, Australia, France200 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since DR-01 is in Phase 1/2 and Part A is still focused on finding the right dose and identifying side effects, what do we currently know about its safety profile, and how does being in an early-phase trial change the risk picture for someone in my situation?
2My specific diagnosis is one of several rare and quite different conditions included in this trial — can you help me understand whether the trial's design and the early efficacy data seem relevant to my particular subtype, like hepatosplenic T-cell lymphoma or LGLL?
3Part B of this trial is measuring overall response rate, meaning how many patients achieve a complete or partial response — based on what's been seen so far, is there any signal of whether DR-01 appears to be working in patients with my type of disease?
4Given that this is an actively recruiting early-phase trial, what would standard treatment options look like for me right now, and is it worth trying one of those first before considering an experimental therapy like DR-01?
5Some of the conditions in this trial, like extranodal NK/T-cell lymphoma or hepatosplenic T-cell lymphoma, can move quickly — how would enrolling in a dose-finding trial affect my ability to start treatment promptly, and what happens if my disease progresses while I'm on the study?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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).
. 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), 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.