Non-hodgkin Lymphoma
Conditions
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.
Interventions
DRUGCD38-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.
Sponsors
Y-mAbs Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A) | 4 weeks |
| Occurrence of dose limiting toxicities during the DLT evaluation period (Part B) | 4 weeks |
Countries
United States
Outcome results
None listed