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

NCT05994157 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 1201
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 6

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.

Conditions

Non-hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

CD38-SADA:177Lu-DOTA Complex

EXPERIMENTAL

Drug: CD38-SADA:177Lu-DOTA Complex

Interventions

CD38-SADA:177Lu-DOTA Complex DRUG

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.

CD38-SADA:177Lu-DOTA Complex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Y-mAbs Therapeutics: lead

Study Sites (6)

HonorHealth

Scottsdale, Arizona, 85258, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Corewell Health-BAMF Health

Grand Rapids, Michigan, 49503, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

East Carolina University Leo W. Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 16, 2023
• Study Start: April 21, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (6)