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

Non-hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994157
• Other study ID #: 1201
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2024
• Est. completion date: January 2028

Study information

• Verified date: January 2024
• Source: Y-mAbs Therapeutics
• Contact: Joris Wilms
• Phone: +4570261414
• Email: clinicaltrials[@]ymabs.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-hodgkin Lymphoma

Intervention

Drug:
• CD38-SADA:177Lu-DOTA Complex
The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA. Both will be administered as an IV infusions.

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California
United States	Corewell Health-BAMF Health	Grand Rapids	Michigan
United States	East Carolina University Leo W. Jenkins Cancer Center	Greenville	North Carolina
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	HonorHealth	Scottsdale	Arizona
United States	Stony Brook Cancer Center	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Y-mAbs Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)		4 weeks
Primary	Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)		4 weeks