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SG2501 Safety Study in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma. | Clinical Trials | Clareo Health

TERMINATEDPHASE1

SG2501 Safety Study in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma.

A Phase Ia/Ib, First-in-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG2501 in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma.

NCT05293912•Hangzhou Sumgen Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a phase Ia/Ib, first-in-Human, open-Label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of SG2501 in subjects with relapsed or refractory hematological malignancies and lymphoma.

Detailed Description

Phase Ia will consist of two parts:an accelerated titration using single patient cohorts to evaluate SG2501 at lower dose levels(Part A), followed by dose-escalation using multipatient cohorts to establish a maximum tolerated dose(MTD)(Part B). Phase Ib will consist of dose expansion cohorts with SG2501 monotherapy in subjects with relapsed or refractory multiple myeloma(MM) or diffuse large B-cell lymphoma(DLBCL).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must meet all the following criteria to be eligible for participation in this study:
•1. Male or female ≥ 18 years.
•2. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedurs.
•1. Phase Ia,dose escalation:
•• Patients with histologically or cytologically confirmed relapsed or refractory hematological malignancies and lymphoma based on WHO(2016) diagnosis who are refractory to or intolerant of established therapies known to provide clinical benefit.
•Note: the histologic subtypes that are eligible for enrollment per the 2016 WHO criteria include multiple myeloma(MM), Chronic Lymphoid Leukemias (CLL) , Waldenstrom Macroglobulinemia (WM) primary systemic amyloidosis (PSA), Hodgkin's Lymphoma(HL) and Non-Hodgkin's Lymphoma(NHL).
•2. Phase Ib, Cohort1 MM Histologically or cytologically confirmed relapsed or refractory multiple myeloma based on WHO diagnosis. Subject has received at least 3 prior anti-myeloma regimens including a proteasome inhibitor (PI), a CD38 antibody and an immunomodulatory agent.
•* Induction,bone marrow transplant with or without maintenance therapy is considered one regimen.
•* Refractory is defined as disease that is nonresponsive on therapy, or progresses within 60 days of last therapy. Nonresponsive disease is defined as either failure to achieve minimal response or development of progressive disease while on therapy
•* For subjects who received more than 1 regimen containing a PI their disease must be refractory to the most recent PI containing regimen.
+22 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria cannot be enrolled:
•1. Symptomatic central nervous system (CNS) metastases or leptomeningeal disease or primary CNS tumors. Patients with asymptomatic CNS metastases who are radiologically and neurologically stable ≥ 4 weeks following CNS-directed therapy and are off steroids for at least 2 weeks prior to dosing may be eligible for study entry.
•2. For lymphoma: red blood cell transfusion within 2 weeks prior to study entry.
•3. History of hemolytic anemia of any cause (including Evans syndrome) within 3 months.
•4. Positive direct antiglobulin test (DAT).
•5. Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 6 months, serious arrhythmias requiring medication.
•6. Significant (requiring anticoagulation or transfusion) thrombotic or hemorrhagic event within 6 months prior to study entry.
•7. Active infection requiring intravenous therapy within 2 weeks prior to study drug administration.
•8. HIV infection with a current or a history of AIDS-defining illness or HIV infection with a CD4+ T cell count \< 350 cells/μL regardless of history of AIDS-defining illness.
•9. Patients with active viral (any etiology) hepatitis are excluded. Patients with serologic evidence of chronic HBV infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antibody test) who have a viral load below the limit quantification (HBV DNA titer \< 200 IU/mL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Medical Monitor. Patients with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification.
+18 more criteria

Locations (8)

Northside Hospital

Atlanta, Georgia, United States

John Theurer Cancer Center at Hackensack UMC

Hackensack, New Jersey, United States

Westchester Medical Center

Hawthorne, New York, United States

Novant Health Forsyth Medical Center

Charlotte, North Carolina, United States

Duke University

Durham, North Carolina, United States

Novant Health Cancer Institute Hematology - Forsyth

Winston-Salem, North Carolina, United States

Gabrail Cancer Center Research, LLC

Canton, Ohio, United States

Texas Oncology / Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Key Dates

Start Date

March 3, 2023

Primary Completion Date

June 30, 2023

Completion Date

June 30, 2023

Last Updated

March 18, 2025

Enrollment

ACTUAL participants

Conditions

Hematological MalignancyLymphoma

Interventions

SG2501

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

SG2501 Safety Study in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma.

Inclusion Criteria

Exclusion Criteria

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