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

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Conditions

Non-hodgkin Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-12
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05994157

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease
  3. * CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory
  4. * Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
  5. * 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.
  1. * Primary central nervous system lymphoma or known central nervous system involvement with lymphoma
  2. * Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA
  3. * Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA
  4. * Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA
  5. * Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA
  6. * \>40% lymphoma bone marrow involvement

Contacts and Locations

Study Contact

Joris Wilms
CONTACT
+4570261414
clinicaltrials@ymabs.com

Study Locations (Sites)

HonorHealth
Scottsdale, Arizona, 85258
United States
City of Hope
Duarte, California, 91010
United States
Corewell Health-BAMF Health
Grand Rapids, Michigan, 49503
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Stony Brook Cancer Center
Stony Brook, New York, 11794
United States
East Carolina University Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834
United States

Collaborators and Investigators

Sponsor: Y-mAbs Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12
Study Completion Date2028-01

Study Record Updates

Study Start Date2024-12
Study Completion Date2028-01

Terms related to this study

Additional Relevant MeSH Terms

  • Non-hodgkin Lymphoma