Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma

Last updated: January 27, 2025
Sponsor: Y-mAbs Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Hematologic Cancer

Marginal Zone Lymphoma

Lymphoma

Treatment

CD38-SADA:177Lu-DOTA Complex

Clinical Study ID

NCT05994157
1201
  • Ages > 18
  • All Genders

Study Summary

Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Target population must have relapsed, progressive or refractory non-hodgkin lymphomaand be ineligible for or have exhausted standard therapeutic options that mayprolong survival

  • The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurabledisease

  • CD38 positive tumor at most recent biopsy (new or archival) documented at centrallaboratory

  • Subject must have an Eastern Cooperative Oncology Group (ECOG) performance statusscore of 0, 1, or 2

  • Each subject must sign an ICF indicating that he or she understands the purpose of,and procedures required for the trial and is willing to participate in the trial.

Exclusion

Exclusion Criteria:

  • Primary central nervous system lymphoma or known central nervous system involvementwith lymphoma

  • Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administeredwithin 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose ofCD38-SADA

  • Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA

  • Autologous stem cell transplantation within 42 days prior to the first dose ofCD38-SADA

  • Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA

  • >40% lymphoma bone marrow involvement

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: CD38-SADA:177Lu-DOTA Complex
Phase: 1
Study Start date:
February 01, 2025
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • The University of Arizona Cancer Center

    Tucson, Arizona 85719-1478
    United States

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • Corewell Health-BAMF Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Stony Brook Cancer Center

    Stony Brook, New York 11794
    United States

    Active - Recruiting

  • East Carolina University Leo W. Jenkins Cancer Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.