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

Last updated: March 31, 2025
Sponsor: Dren Bio
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoproliferative Disorders

Leukemia

Mycosis Fungoides

Treatment

DR-01

Clinical Study ID

NCT05475925
DR-01-ONC-001
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria (All Subjects):

  1. ≥18 years of age.

  2. Able to understand and comply with protocol-required study procedures andvoluntarily sign a written informed consent document.

  3. Sufficient key organ performance and coagulation.

  4. Female subjects of childbearing potential (postmenarcheal, has an intact uterus andat least one ovary, and is <1 year postmenopausal) must agree to use a highlyeffective method of contraception from enrollment through at least 12 months afterlast dose of DR-01.

  5. Male subjects must agree to use acceptable effective method(s) of contraception. Subjects with LGLL must also meet inclusion criteria 6 and 7.

  6. Must have discontinued at least one prior line of systemic therapy.

  7. Additional immunophenotypic criteria must be met. Disease-specific Inclusion Criteria (Cytotoxic Lymphomas): Subjects with cytotoxic lymphomas must also meet inclusion criteria 8,9, and 10.

  8. Subjects must have failed at least two prior systemic regimens.

  9. Availability of post-progression tissue sample or willingness to consent to abaseline biopsy.

  10. Histologically confirmed diagnosis of a cytotoxic lymphoma by a hematopathologist (according to the WHO 2016 classification [Swerdlow 2016]).

  11. For Part A only, evaluable disease is acceptable.

  12. For Part B2 only:

Subjects must have radiographically measurable disease to be assessed by Lugano criteria. Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen criteria (Olsen 2021) or leukemic involvement that can be evaluated using a modified TPLL response criteria (Staber 2019).

Subjects with hepatosplenic disease or other variants that do not have measurable disease by Lugano criteria (Cheson 2014) may be eligible upon discussion with the Medical Monitor if they have identifiable leukemic involvement in BM or peripheral blood (meeting the CD8+ cytotoxic phenotype definition) that can be evaluated for response using a modified TPLL response criteria (Staber 2019), or skin involvement that can be evaluated using Olsen criteria (Olsen 2021).

Exclusion

Exclusion Criteria:

Disease-specific Exclusion Criteria; LGLL and ANKL:

  1. A reactive LGL lymphocytosis to a viral infection or LGL associated withmyelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). The following exclusion criteria apply to all subjects:

  2. Active systemic infection or severe localized infection requiring systemicantibiotics, 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), orhepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleicacid). Subjects with HCV with undetectable virus after treatment are eligible.

  8. History of clinically significant cardiac disease or congestive heart failuregreater than New York Heart Association (NYHA) Class II.

  9. Use of systemic corticosteroids (e.g., >5 mg/day prednisone or equivalent forsubjects with LGL leukemia (subjects on 20 mg prednisone or equivalent to treat LGLleukemia must be weaned within 28 days post C1D1 to 5 mg) and >10 mg/day prednisoneor equivalent for subjects with cytotoxic lymphoma) within 15 days (except forprophylaxis for radiodiagnostic contrast reactions), or other non-biologicalimmunosuppressive drugs within 15 days, prior to C1D1. Patients on stable prednisone ≤10 mg for documented rheumatologic/autoimmune conditions are exempted from thisrequirement.

  10. Any condition requiring hormonal therapy (except for contraception, hormonereplacement therapy and hormonal prophylaxis for a prior malignancy).

  11. Any other medical or psychiatric condition, or laboratory abnormality that wouldincrease the risk associated with study participation, in the opinion of theInvestigator or Medical Monitor.

  12. Toxicities from previous anticancer therapies must have resolved to baseline levelsor to Grade 1 (except for alopecia, peripheral neuropathy, or hematologic parametersmeeting 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 plexusblockade).

Study Design

Total Participants: 69
Treatment Group(s): 1
Primary Treatment: DR-01
Phase: 1/2
Study Start date:
July 13, 2022
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Dren Investigational Site

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Dren Investigational Site

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Dren Investigational Site

    Richmond, Victoria 3121
    Australia

    Active - Recruiting

  • Dren Investigational Site

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Dren Investigational Site

    Pierre-Bénite, 69310
    France

    Active - Recruiting

  • Dren Investigational Site

    Rennes, 35000
    France

    Active - Recruiting

  • Dren Investigational Site

    Toulouse, 31059
    France

    Active - Recruiting

  • Dren Investigational Site

    Berlin, 10117
    Germany

    Active - Recruiting

  • Dren Investigational Site

    Cologne, 50937
    Germany

    Site Not Available

  • Dren Investigational Site

    Leipzig, 04103
    Germany

    Active - Recruiting

  • Dren Investigational Site 1

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Dren Investigational Site 2

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Dren Investigational Site

    Bologna, 40126
    Italy

    Active - Recruiting

  • Dren Investigational Site 1

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Dren Investigational Site 2

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Dren Investigational Site

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • Dren Investigational Site 1

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Dren Investigational Site 2

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Dren Investigational Site 3

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Dren Investigational Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Dren Investigational Site

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Dren Investigational Site

    Tainan,
    Taiwan

    Active - Recruiting

  • Dren Investigational Site

    Taipei,
    Taiwan

    Active - Recruiting

  • Dren Investigational Site

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Dren Investigational Site

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Dren Investigational Site

    Duarte, California 91010
    United States

    Active - Recruiting

  • Dren Investigational Site

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Dren Investigational Site

    New Haven, Connecticut 06519
    United States

    Site Not Available

  • Dren Investigational Site

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Dren Investigational Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Dren Investigational Site

    New York, New York 10021
    United States

    Active - Recruiting

  • Dren Investigational Site 1

    New York, New York 10021
    United States

    Active - Recruiting

  • Dren Investigational Site 2

    New York, New York 10032
    United States

    Site Not Available

  • Dren Investigational Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Dren Investigational Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Dren Investigational Site

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Dren Investigational Site 1

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Dren Investigational Site 2

    Pittsburg, Pennsylvania 15213
    United States

    Active - Recruiting

  • Dren Investigational Site 2

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Dren Investigational Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Dren Investigational Site

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • Dren Investigational Site

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Dren Investigational Site

    Seattle, Washington 98109
    United States

    Active - Recruiting

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