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

• Sponsor: Y-mAbs Therapeutics (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05994157
• Collaborator: (none)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 23

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-hodgkin Lymphoma	Drug: CD38-SADA:177Lu-DOTA Complex	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Feb 1, 2024
• Anticipated Primary Completion Date: Jan 1, 2026
• Anticipated Study Completion Date: Jan 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD38-SADA:177Lu-DOTA Complex	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.

Outcome Measures

Primary Outcome Measures

1. Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A) [4 weeks]

2. Occurrence of dose limiting toxicities during the DLT evaluation period (Part B) [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Y-mAbs Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Y-mAbs Therapeutics
• ClinicalTrials.gov Identifier: NCT05994157
• Other Study ID Numbers: 1201
• First Posted: Aug 16, 2023
• Last Update Posted: Aug 16, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Aug 16, 2023