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

Recruiting now · Phase 1/Phase 2

Conditions studied: LGLL - Large Granular Lymphocytic Leukemia, Primary Cutaneous Gamma-Delta T-Cell Lymphoma, Primary Cutaneous CD8+ Aggressive Epidermotropic T-Cell Lymphoma, Hepatosplenic T-cell Lymphoma, Subcutaneous Panniculitis-Like T-Cell Lymphoma, Aggressive NK Cell Leukemia, Systemic EBV1 T-cell Lymphoma, if CD8 Positive, Hydroa Vacciniforme-Like Lymphoproliferative Disorder, Extranodal NK/T Cell Lymphoma, Nasal Type, Enteropathy-Associated T-Cell Lymphoma, Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma, Cytotoxic PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker), Cutaneous PTCL-NOS (CD8+ or CD56+ and Cytotoxic Marker)

In brief

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

Key facts

Study ID

NCT05475925

Run by

Dren Bio

People needed

200

Starts

2022-07-13

Expected to finish

2026-12-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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).

Where it is running

• Dren Investigational Site — Taipei, Taiwan (enrolling)
• Dren Investigational Site — Duarte, California, United States (enrolling)
• Dren Investigational Site — Irvine, California, United States (enrolling)
• Dren Investigational Site — Redwood City, California, United States (enrolling)
• Dren Investigational Site — New Haven, Connecticut, United States (enrolling)
• Dren Investigational Site — Tampa, Florida, United States (enrolling)
• Dren Investigational Site — Boston, Massachusetts, United States (enrolling)
• Dren Investigational Site 1 — New York, New York, United States (enrolling)
• Dren Investigational Site — Birmingham, Alabama, United States (enrolling)
• Dren Investigational Site — Columbus, Ohio, United States (enrolling)
• Dren Investigational Site 2 — Pittsburgh, Pennsylvania, United States (enrolling)
• Dren Investigational Site — Houston, Texas, United States (enrolling)
• Dren Investigational Site — Charlottesville, Virginia, United States (enrolling)
• Dren Investigational Site — Fairfax, Virginia, United States (enrolling)
• Dren Investigational Site — Seattle, Washington, United States (enrolling)
• Dren Investigational Site — Clayton, Victoria, Australia (enrolling)
• Dren Investigational Site — Richmond, Victoria, Australia (enrolling)
• Dren Investigational Site — Nedlands, Washington, Australia (enrolling)
• Dren Investigational Site — Pierre-Bénite, France (enrolling)
• Dren Investigational Site — Rennes, France (enrolling)
• Dren Investigational Site — Toulouse, France (enrolling)
• Dren Investigational Site — Berlin, Germany (enrolling)
• Dren Investigational Site — Cologne, Germany (enrolling)
• Dren Investigational Site — Leipzig, Germany (enrolling)
• Dren Investigational Site 1 — Hong Kong, Hong Kong, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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