A Study of DR-0201 in Subjects With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

Last updated: February 26, 2025
Sponsor: Dren Bio
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Lymphoma, B-cell

Treatment

DR-0201

Clinical Study ID

NCT06392477
DR-0201-ONC-001
  • Ages > 18
  • All Genders

Study Summary

This is a multicenter, multiple expansion cohort, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-0201 in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • At least 2 prior lines of therapy and without treatment options that are recognizedto offer clinical benefit

  • Adequate marrow reserve, renal function, and hepatic function

  • Measurable disease defined as ≥ 1 bi-dimensionally measurable nodal lesion of > 1.5cm in the longest dimension for subjects with PET avid disease for subtypes withnodular disease or at least one bi-dimensionally measurable extranodal lesion,defined as > 1.0 cm in its longest dimension

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • Life expectancy of ≥ 12 weeks

  • Use of a highly effective contraceptive measure all males and all females ofchildbearing potential during study through 180 days post last dose; Females ofchildbearing potential need to have a negative serum pregnancy test within 7 daysprior to first dose.

  • Tumor tissue block or 3 to 5 unstained slides from lymph node or other relevantbiopsy collected in the past 6 months or subject must be willing to provide abaseline biopsy, unless not safely accessible

  • In subjects with prior CAR-T therapy, >90 days post CAR-T at day of first dosing

Exclusion

Key Exclusion Criteria:

  • Burkitt's or Burkitt's like lymphoma or lymphoplastic lymphoma

  • Current or past history of central nervous system (CNS) lymphoma

  • Prior allogeneic stem cell transplantation except for those with FL and MCL, who areexcluded if transplant occurred less than 100 days prior to Screening or if theyexhibit active signs of or received treatment for graft versus host disease (GvHD)

  • Prior solid organ transplantation

  • Autologous stem cell transplantation ≤ 100 days

  • History of autoimmune disease, including but not limited to myasthenia gravis,myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis,inflammatory bowel disease, vascular thrombosis associated with antiphospholipidsyndrome, Wegener's granulamatosis, Sjorgen's syndrome, Guillain-Barre-syndrome,multiple sclerosis vasculitis, or glomerulonephritis (subjects with a remote historyof, or well-controlled autoimmune disease, may be eligible)

  • Major surgery in the last 28 days prior to dosing

  • Evidence of significant, uncontrolled concomitant disease that could affectcompliance with study

  • Current or past history of CNS disease (Subjects with remote history of non-lymphomaCNS disease and with no residual neurologic deficits may be eligible to enroll)

  • QT interval corrected by Fridericia's formula (QTcF) > 480 msec

  • Significant cardiovascular disease

  • Received systemic therapy with anti-cancer therapies 4 weeks prior to first DR-0201administration or 5 half-lives of the drug, whatever is shorter. Treatment withcorticosteroid ≤ 25mg/day prednisone or equivalent is allowed. Inhaled and topicalsteroids are allowed.

  • Prior treatment with systemic immunotherapy agents included, but not limited toradio immunoconjugates, antibody drug conjugates, cytokines, immune checkpointinhibitors 4 weeks or 5 half-lives of the drug, whatever is shorter

  • Positive hepatitis B virus (HBV) polymerase chain reaction (PCR) test. Subjects witha positive serologic test for HBV (i.e., positive hepatitis B core antibody [HBcAb]and negative for hepatitis B surface antigen [HBsAg]) must have a negative PCR test

  • Known infection with HIV, HBV, or hepatitis C virus (HCV). Subjects who areHIV-positive with undetectable HIV RNA and at least 3 months on a highly effectiveantiviral therapy (HART) and subjects who are HCV-positive who have completed atleast 1 month of highly effective antiviral therapy may be eligible.

  • Acute bacterial, viral, or fungal infection at baseline

  • Active infection requiring systemic (IV) treatment with antimicrobial, antifungal,or antiviral agents in the 2 weeks prior to dosing.

  • Administration of a live, attenuated vaccine within 4 weeks prior to first DR-0201administration or anticipation that such vaccine administration would be necessaryduring the course of the study

  • Another invasive malignancy in the last 2 years (except basal cell carcinoma andtumors deemed by the investigator to be of low likelihood for recurrence)

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: DR-0201
Phase: 1
Study Start date:
July 15, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Dren Investigational Site

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Dren Investigational Site

    Douglas, Queensland 4814
    Australia

    Active - Recruiting

  • Dren Investigational Site

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Dren Investigational Site

    Richmond, Victoria
    Australia

    Active - Recruiting

  • Dren Investigational Site

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Dren Investigational Site

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Dren Investigational Site

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Dren Investigational Site

    Goyang-si, 10408
    Korea, Republic of

    Active - Recruiting

  • Dren Investigational Site

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Dren Investigational Site

    Belgrade,
    Serbia

    Active - Recruiting

  • Dren Investigational Site

    Kragujevac,
    Serbia

    Active - Recruiting

  • Dren Investigational Site

    Niš,
    Serbia

    Active - Recruiting

  • Dren Investigational Site

    Sremska Kamenica,
    Serbia

    Active - Recruiting

  • Dren Investigational Site

    Kent Ridge, 119228
    Singapore

    Active - Recruiting

  • Dren Investigational Site 3

    Kent Ridge, 119228
    Singapore

    Active - Recruiting

  • Dren Investigational Site

    Novena, 308433
    Singapore

    Site Not Available

  • Dren Investigational Site 1

    Novena, 308433
    Singapore

    Site Not Available

  • Dren Investigational Site 2

    Novena, 308433
    Singapore

    Site Not Available

  • Dren Investigational Site 2

    Seng, 308433
    Singapore

    Active - Recruiting

  • Dren Investigational Site

    Chang Hua,
    Taiwan

    Active - Recruiting

  • Dren Investigational Site

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • Dren Investigational Site

    Taipei, 100
    Taiwan

    Active - Recruiting

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