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

Y-mAbs Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Non-hodgkin Lymphoma

Treatments

Drug: CD38-SADA:177Lu-DOTA Complex

Study type

Interventional

Funder types

Industry

Identifiers

NCT05994157

1201

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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