Health Trials

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

ConditionsLGLL - Large Granular Lymphocytic LeukemiaPrimary Cutaneous Gamma-Delta T-Cell LymphomaPrimary Cutaneous CD8+ Aggressive Epidermotropic T-Cell LymphomaHepatosplenic T-cell LymphomaSubcutaneous Panniculitis-Like T-Cell LymphomaAggressive NK Cell LeukemiaSystemic EBV1 T-cell Lymphoma, if CD8 PositiveHydroa Vacciniforme-Like Lymphoproliferative DisorderExtranodal NK/T Cell Lymphoma, Nasal TypeEnteropathy-Associated T-Cell LymphomaMonomorphic Epitheliotropic Intestinal T-Cell LymphomaCytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDren Bio

About this trial

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

Eligibility criteria

Qualifiers

≥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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • DR-01

Treatment groups

200 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

37
Australia
Dren Investigational Site3168, ClaytonVictoria, Australia
Dren Investigational Site3121, RichmondVictoria, Australia
Dren Investigational Site6009, NedlandsWashington, Australia
France
Dren Investigational Site69310, Pierre-Bénite France

Sponsors and collaborators

Dren Bio

Lead sponsor

Source ClinicalTrials.gov