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

Description

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

Conditions

LGLL - Large Granular Lymphocytic Leukemia, Primary Cutaneous T-Cell Lymphoma - Category, Primary Cutaneous CD8-Positive 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, Indolent Chronic Lymphoproliferative Disorder (CLPD) (CD8+ or NK Derived) of the GI Tract, Other CD8+/NK Cell Driven Lymphoma Not Listed Above

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Study Overview

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Study Details

Study overview

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

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

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

Condition
LGLL - Large Granular Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Birmingham

Dren Investigational Site, Birmingham, Alabama, United States, 35233

Duarte

Dren Investigational Site, Duarte, California, United States, 91010

Redwood City

Dren Investigational Site, Redwood City, California, United States, 94063

New York

Dren Investigational Site 1, New York, New York, United States, 10021

New York

Dren Investigational Site 2, New York, New York, United States, 10032

Columbus

Dren Investigational Site, Columbus, Ohio, United States, 43210

Philadelphia

Dren Investigational Site 1, Philadelphia, Pennsylvania, United States, 19107

Pittsburgh

Dren Investigational Site 2, Pittsburgh, Pennsylvania, United States, 15213

Houston

Dren Investigational Site, Houston, Texas, United States, 77030

Charlottesville

Dren Investigational Site, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  • 2. Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.
  • 3. Active or suspected malignant central nervous system involvement.
  • 4. Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).
  • 5. Active known second malignancy.
  • 6. Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).
  • 7. 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.
  • 8. History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.
  • 9. Use of systemic corticosteroids (e.g., \>5 mg/day prednisone or equivalent for subjects with LGL leukemia (subjects on 20 mg prednisone or equivalent to treat LGL leukemia must be weaned within 28 days post C1D1 to 5 mg) and \>10 mg/day prednisone or equivalent for subjects with cytotoxic lymphoma) within 15 days (except for prophylaxis for radiodiagnostic contrast reactions), or other non-biological immunosuppressive drugs within 15 days, prior to C1D1. Patients on stable prednisone ≤10 mg for documented rheumatologic/autoimmune conditions are exempted from this requirement.
  • 10. Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).
  • 11. 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.
  • 12. 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).
  • 13. Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days
  • 14. Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.
  • 15. Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Dren Bio,

Kimberley Dilley, MD, MPH, STUDY_DIRECTOR, Dren Bio

Study Record Dates

2025-12