RECRUITING

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

Description

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.

Conditions

Non-hodgkin Lymphoma
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Related Conditions:

Non-hodgkin Lymphoma

Study Overview

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Study Details

Study overview

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.

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

Condition
Non-hodgkin Lymphoma
Intervention / Treatment

-

Contacts and Locations

Scottsdale

HonorHealth, Scottsdale, Arizona, United States, 85258

Duarte

City of Hope, Duarte, California, United States, 91010

Grand Rapids

Corewell Health-BAMF Health, Grand Rapids, Michigan, United States, 49503

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Stony Brook

Stony Brook Cancer Center, Stony Brook, New York, United States, 11794

Greenville

East Carolina University Leo W. Jenkins Cancer Center, Greenville, North Carolina, United States, 27834

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Y-mAbs Therapeutics,

Study Record Dates

2028-01