Study of SGR-1505 for Mature B-Cell Neoplasms

This study is testing a new oral medication called SGR-1505 for people with mature B-cell neoplasms, including types of Non-Hodgkin Lymphoma like DLBCL and Waldenstrom Macroglobulinemia. The main goal is to understand how safe SGR-1505 is, what side effects it might cause, and to find the best dose. You may be able to join if you have a confirmed B-cell malignancy that is measurable and you meet certain health criteria, such as having a good performance status (ECOG 0 or 1) and a life expectancy of at least 12 weeks. The study plans to enroll about 98 participants.

Study design
This is an interventional study, meaning participants will receive SGR-1505. It aims to enroll 98 participants, but the phase and specific design details like randomization or blinding are not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects throughout the study, up to 2 years.

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NCT05544019

Study of SGR-1505 in Mature B-Cell Neoplasms

Recruiting
PHASE1Ages 18+InterventionalTreatment
Schrödinger, Inc.
~98 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:SGR-1505

At a glance

Recruiting sites
36 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.
Measured over Throughout the study, up to 2 years.
+1 more outcome measured
Mature B-Cell Neoplasm
Non Hodgkin Lymphoma
DLBCL
Waldenstrom Macroglobulinemia
MALT Lymphoma
Follicular Lymphoma
Pediatric-Type Follicular Lymphoma
IRF4 Gene Rearrangement
EBV-Positive DLBCL, Nos
Burkitt Lymphoma
Plasmablastic Lymphoma
High-grade B-cell Lymphoma
Primary Cutaneous Follicle Center Lymphoma
Primary Effusion Lymphoma
Mantle Cell Lymphoma
DLBCL Germinal Center B-Cell Type
Primary Mediastinal Large B Cell Lymphoma
T-Cell/Histiocyte Rich Lymphoma
ALK-Positive Large B-Cell Lymphoma
Primary Cutaneous Diffuse Large B-Cell Lymphoma
Splenic Marginal Zone Lymphoma
Chronic Lymphocytic Leukemia
Nodal Marginal Zone Lymphoma
HHV8-Positive DLBCL, Nos
Lymphoplasmacytic Lymphoma
Duodenal-Type Follicular Lymphoma
36 sites across 20 states
Spain6
Italy5
New York3
Poland3
Ohio2
France2
Romania2
Arizona1
  • Frank G Basile, M.D. · STUDY_DIRECTOR · Schrodinger Inc.

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Eligibility criteria

Inclusion

Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.
Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy ≥ 12 weeks.

Exclusion

The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).
Subject has previous invasive malignancy in the last 2 years.
Subject has a known allergy to SGR-1505 or excipients of SGR-1505.
Subject has symptomatic or active CNS involvement of disease.
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.
  • Nature, severity, and number of incidences of adverse events (AEs), serious AEs (SAEs), and AEs leading to treatment discontinuation.Throughout the study, up to 2 years.
  • Nature and number of incidences of dose limiting toxicity (DLT).The first 21 days.

    A DLT is an AE that requires treatment interruption.