search
Back to results

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

Primary Purpose

Non-hodgkin Lymphoma

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
CD38-SADA:177Lu-DOTA Complex
Sponsored by
Y-mAbs Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-hodgkin Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CD38-SADA:177Lu-DOTA Complex

    Arm Description

    Outcomes

    Primary Outcome Measures

    Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
    Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)

    Secondary Outcome Measures

    Full Information

    First Posted
    August 8, 2023
    Last Updated
    August 15, 2023
    Sponsor
    Y-mAbs Therapeutics
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05994157
    Brief 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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2024 (Anticipated)
    Primary Completion Date
    January 2026 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Y-mAbs Therapeutics

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-hodgkin Lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CD38-SADA:177Lu-DOTA Complex
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    CD38-SADA:177Lu-DOTA Complex
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Tumor imaging and occurrence of dose limiting toxicities (DLT) during the DLT evaluation period (Part A)
    Time Frame
    4 weeks
    Title
    Occurrence of dose limiting toxicities during the DLT evaluation period (Part B)
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs