ClinicalTrials.gov record NCT05475925

A Study of DR-01 in Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Multicenter, Open-Label, First-In-Human, Multiple Expansion Cohort, Phase 1/2 Study to Evaluate the Safety and Efficacy of DR-01 in Adult Subjects With Large Granular Lymphocytic Leukemia or Cytotoxic Lymphomas

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).
Age18 years old and older
SexAll
LocationAustralia, France, Germany, Hong Kong, Italy, South Korea, Spain, Taiwan, United States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1/2, first‑in‑human study gives the investigational monoclonal antibody DR-01 to adults with large granular lymphocytic leukemia or various cytotoxic T‑cell and NK‑cell lymphomas. Part A uses dose‑escalation (with a possible de‑escalation cohort) to assess safety, tolerability, and pharmacology; Part B expands cohorts at an optimized dose/regimen to assess anti‑tumor activity. Dosing regimens vary during the first month and then move to monthly dosing for up to 25 cycles.

What it is studying. The study is testing how safe and tolerable DR-01 is, how the body processes it (pharmacokinetics/pharmacodynamics), what dose/regimen is appropriate, and whether it shows anti‑tumor activity in these diseases.

What the researchers hope to learn. To determine the safety and tolerability of DR-01 and the incidence of dose‑limiting toxicities; to identify a pharmacologically optimized dose and regimen using integrated safety, efficacy, and pharmacology data; and to measure anti‑tumor activity, including overall response rate, in the enrolled disease groups.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • DR-01

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • (All Subjects):
  • ≥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.
  • Subjects with LGLL must also meet inclusion criteria 6 and 7.
  • Must have discontinued at least one prior line of systemic therapy.
  • Additional immunophenotypic and symptomatic 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 one prior systemic regimens.
  • Availability of post-progression tissue sample or willingness to consent to a baseline 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, evaluable by the following response criteria as documented during Screening:
  • For cytotoxic PTCL-NOS, ENKTL, MEITL, EATL, SPTCL - Subjects must have radiographically measurable disease by computed tomography (CT) or CT/positron emission tomography (PET) scan defined as at least one node measuring >1.5 cm or measurable extranodal lesion of at least 1.0 cm in longest diameter to be evaluated by Lugano criteria (Cheson 2014).
  • For PCGDTCL, ET-CTCL, HVLPD, cytotoxic CuPTCL-NOS - Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or have leukemic involvement that can be evaluated using modified TPLL response criteria (Staber 2019).
  • For HSTCL, ANKL, SysEBV TCL - Subjects with hepatosplenic disease without measurable disease by Lugano criteria (Cheson 2014) or leukemic involvement in BM or peripheral blood that is evaluable for response using a modified TPLL response criteria (Staber 2019).

Exclusion criteria

  • Disease-specific Exclusion Criteria; LGLL and ANKL:
  • A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • The following exclusion criteria apply to all subjects:
  • 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.
  • Use of systemic corticosteroids at prohibited dose levels within 15 days prior to C1D1 (except for prophylaxis for radiodiagnostic contrast reactions and study-defined premedication) or use of other non-biological immunosuppressive drugs within 15 days or 5 half-lives (whichever is less) prior to C1D1.
  • Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).
  • Any other medical or psychiatric condition, or laboratory abnormality that would increase the risk associated with study participation, in the opinion of the Investigator or Medical Monitor.
  • Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, peripheral neuropathy, or hematologic parameters meeting 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 plexus blockade).

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If enrolled you would receive the experimental drug DR‑01 in a dose‑finding Phase 1/2 study: Part A tests escalating (or if needed de‑escalating) dose levels and schedules, and Part B treats groups at the optimized dose/regimen determined in Part A. Initial first‑month schedules may be bi‑weekly, on Days 1, 8, 15, 29, or on Days 1–5, 15, 29, followed by monthly dosing thereafter for up to 25 cycles total. Study visits include receiving the study drug, regular safety checks and blood draws for safety and pharmacokinetic/pharmacodynamic testing; disease assessments with CT or CT/PET scans or standardized skin lesion measurements; and for some lymphoma participants the need to provide a recent post‑progression tissue sample or agree to a baseline biopsy. You would be monitored for side effects and treatment response during and after dosing according to the protocol's safety and response assessments.

How the study is structured. Open‑label, non‑randomized Phase 1/2 trial with a sequential design. Part A is dose‑escalation (multiple dose levels, with a de‑escalation option if needed) using one of several first‑month dosing patterns, followed by monthly dosing thereafter. Part B has two dose‑expansion cohorts (one for LGL leukemia, one for cytotoxic lymphomas) given the pharmacologically optimized dose/regimen identified in Part A. There is no masking.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Australia, France, Germany, Hong Kong, Italy, South Korea, Spain, Taiwan, United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on large granular lymphocytic leukemia

Clinical trials16 trials listed for large granular lymphocytic leukemiaEvery trial the registry lists for large granular lymphocytic leukemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in large granular lymphocytic leukemia researchLatest monthly update: September 2026. Includes: Treatment response reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 13, 2022
Primary completion
December 2026 (estimated)
Study completion
December 2026 (estimated)
Target enrollment
200 participants (estimated)
Last updated on registry
Jun 17, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Dren Bio

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (37)

Terms used on this page · explanations by MedicalUpdates.ai

first-in-human
The first study in which a treatment is given to people. Safety is the main question and the number of participants is usually small.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
pharmacodynamics
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
during Screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
immunosuppressive
A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
HSCT
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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