What side effects are associated with this type of intervention?

Common treatments for Chronic Lymphocytic Leukemia (CLL) include monoclonal antibodies like rituximab, targeted agents such as ibrutinib, and combination therapies like bendamustine with rituximab (BR). Rituximab can cause infusion reactions, particularly in the first cycle, with symptoms like fever, chills, and low blood pressure. Ibrutinib is associated with non-hematologic toxicities such as diarrhea, fatigue, and hypertension, as well as hematologic toxicities like thrombocytopenia and neutropenia. Bendamustine can also cause infusion reactions and hematologic toxicities. Understanding these side effects is essential for evaluating the safety and dosage of new treatments like SGR-1505.

What prior FDA approvals exist?

Several drugs have been FDA-approved for the treatment of Chronic Lymphocytic Leukemia (CLL). These include monoclonal antibodies like rituximab, ofatumumab, and obinutuzumab, which target CD20 on B-cells. Additionally, small molecule inhibitors such as ibrutinib (a Bruton's tyrosine kinase inhibitor) and venetoclax (a BCL-2 inhibitor) have been approved for their efficacy in CLL. Combination therapies, such as venetoclax plus obinutuzumab, have shown significant improvements in progression-free survival. These treatments are similar to the investigational agent SGR-1505, which is being evaluated for safety and dosage in mature B-cell neoplasms, including CLL.

What other types of research exist?

Promising novel alternatives for CLL treatment in 2024 include BTK inhibitors like ibrutinib, acalabrutinib, and zanubrutinib, which have shown high efficacy and manageable safety profiles. Venetoclax, often combined with obinutuzumab, is another effective option, particularly for achieving undetectable minimal residual disease. These agents offer targeted therapy options with substantial clinical trial support.

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SGR-1505 for B-Cell Lymphoma

Phase 1

Recruiting

Research Sponsored by Schrödinger, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have measurable or detectable disease according to the applicable disease-specific classification system.

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Must not have

Subject has previous invasive malignancy in the last 2 years.

Subject has symptomatic or active CNS involvement of disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study, up to 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing SGR-1505, a new oral drug that blocks a protein called MALT1, in patients with B-cell lymphomas that have returned or did not respond to previous treatments. The goal is to find the safest and most effective dose while also seeing how well it works against the cancer.

Who is the study for?

This trial is for people with various types of mature B-cell cancers, like lymphoma and leukemia. Participants must have a confirmed diagnosis, measurable disease, be relatively active (ECOG 0-2), and expected to live at least 12 weeks. They can't join if they've had another cancer in the last 2 years or need immediate treatment for indolent NHL/CLL unless out of options.

What is being tested?

The study is testing SGR-1505's safety and how well patients tolerate it. It aims to find the highest dose patients can handle without severe side effects (MTD) or suggest an optimal dose for further research (RD).

What are the potential side effects?

Specific side effects are not listed but generally could include reactions related to immune system activation, infusion-related symptoms, fatigue, digestive issues, blood disorders, or increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My disease can be measured or detected with tests.

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I can take care of myself and am up and about more than half of my waking hours.

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I have a confirmed diagnosis of mature B-cell cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had cancer that spread into surrounding tissues within the last 2 years.

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My cancer has spread to my brain and is causing symptoms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study, up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study, up to 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, up to 2 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nature and number of incidences of dose limiting toxicity (DLT).

Secondary study objectives

Disease Control Rate

Duration of Response (DOR)

Objective Response Rate (ORR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

Up to 9 dose levels in total will be evaluated across two dosing schedules. Eligible patients will be assigned to a dose level cohort according to an accelerated titration design that will transition to a traditional 3+3 dose escalation.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Targeted therapies for Chronic Lymphocytic Leukemia (CLL) include agents like ibrutinib, venetoclax, and obinutuzumab. Ibrutinib inhibits Bruton's tyrosine kinase (BTK), reducing CLL cell survival and proliferation. Venetoclax targets BCL-2, promoting cancer cell death. Obinutuzumab, a monoclonal antibody, targets CD20 on B-cells, enhancing immune-mediated cell destruction. These treatments offer more precise options with potentially fewer side effects compared to traditional chemotherapy, improving patient outcomes and quality of life.

Targeting the tumor microenvironment in chronic lymphocytic leukemia.Diagnosis, treatment and supportive management of chronic lymphocytic leukemia: recommendations of the Dutch HOVON CLL working group.Targeted therapy in the treatment of chronic lymphocytic leukemia: facts, shortcomings and hopes for the future.