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NCT05994157 | RECRUITING | Non-hodgkin Lymphoma

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

Y-mAbs Therapeutics

Brief 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.

Condition or disease

Non-hodgkin Lymphoma

Intervention/treatment

CD38-SADA:177Lu-DOTA Complex

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma
Actual Study Start Date : 2025-02
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2028-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival
  • * The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease
  • * CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory
  • * Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score 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 Criteria
  • * Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
  • * Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-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 of CD38-SADA
  • * Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
  • * \>40% lymphoma bone marrow involvement
Phase 1, Open-label, Dose-escalation Trial with CD38-SADA:177 Lu-DOTA Drug Complex in Subjects with Relapsed or Refractory Non-Hodgkin Lymphoma

Location Details

NCT05994157

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

HonorHealth

Scottsdale, Arizona, United States, 85258

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, Road cancer

Corewell Health-BAMF Health

Grand Rapids, Road cancer, United States, 49503

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, New York

Stony Brook Cancer Center

Stony Brook, New York, United States, 11794

NOT YET RECRUITING

United States, North Carolina

East Carolina University Leo W. Jenkins Cancer Center

Greenville, North Carolina, United States, 27834