RECRUITING

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

Talk to us

Conditions

LGLL - Large Granular Lymphocytic LeukemiaPrimary Cutaneous T-Cell Lymphoma - CategoryPrimary Cutaneous CD8-Positive 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 LymphomaIndolent Chronic Lymphoproliferative Disorder (CLPD) (CD8+ or NK Derived) of the GI TractOther CD8+/NK Cell Driven Lymphoma Not Listed AboveLGLLCytotoxicLymphomaANKLEATLMEITLENKLHVLPDLeukemia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2022-07-13
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05475925

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. A reactive LGL lymphocytosis to a viral infection or LGL associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
  2. 2. Active systemic infection or severe localized infection requiring systemic antibiotics, antivirals or antifungals.
  3. 3. Active or suspected malignant central nervous system involvement.
  4. 4. Life-threatening, severe complications of malignancy (e.g., uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation).
  5. 5. Active known second malignancy.
  6. 6. Infection with human immunodeficiency virus (HIV) type 1 or 2 (HIV-1 or HIV-2).
  7. 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. 8. History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II.
  9. 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. 10. Any condition requiring hormonal therapy (except for contraception, hormone replacement therapy and hormonal prophylaxis for a prior malignancy).
  11. 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. 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. 13. Autologous HSCT within 40 days of C1D1, allogeneic HSCT within 90 days
  14. 14. Any immunosuppressive therapy for GVHD for subjects who are post allogeneic HSCT.
  15. 15. Major surgery within 28 days of C1D1 (requires more than local anesthesia or plexus blockade).

Contacts and Locations

Study Contact

Dren Central Contact
CONTACT
415-737-5277
clinops@drenbio.com

Principal Investigator

Kimberley Dilley, MD, MPH
STUDY_DIRECTOR
Dren Bio

Study Locations (Sites)

Dren Investigational Site
Birmingham, Alabama, 35233
United States
Dren Investigational Site
Duarte, California, 91010
United States
Dren Investigational Site
Redwood City, California, 94063
United States
Dren Investigational Site 1
New York, New York, 10021
United States
Dren Investigational Site 2
New York, New York, 10032
United States
Dren Investigational Site
Columbus, Ohio, 43210
United States
Dren Investigational Site 1
Philadelphia, Pennsylvania, 19107
United States
Dren Investigational Site 2
Pittsburgh, Pennsylvania, 15213
United States
Dren Investigational Site
Houston, Texas, 77030
United States
Dren Investigational Site
Charlottesville, Virginia, 22903
United States
Dren Investigational Site
Fairfax, Virginia, 22031
United States
Dren Investigational Site
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Dren Bio

  • Kimberley Dilley, MD, MPH, STUDY_DIRECTOR, Dren Bio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-13
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-07-13
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • LGLL
  • Cytotoxic
  • Lymphoma
  • ANKL
  • EATL
  • MEITL
  • ENKL
  • HVLPD
  • Leukemia

Additional Relevant MeSH Terms

  • 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