What side effects are associated with this type of intervention?

Common treatments for blood cancers, including chemotherapy, targeted therapy, and hematopoietic cell transplantation, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Targeted therapies, such as tyrosine kinase inhibitors, may lead to side effects like diarrhea, liver dysfunction, and cardiovascular issues. Hematopoietic cell transplantation, particularly myeloablative conditioning, is associated with high morbidity, including hematologic, gastrointestinal, hepatic, and pulmonary toxicities, and a significant risk of treatment-related mortality. Investigational drugs like SG2501, while not specifically detailed, generally carry risks of similar adverse effects, including immunogenic reactions, organ toxicity, and potential for severe infections.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of blood cancers. Notable examples include CAR-T cell therapies like brexucabtagene autoleucel (KTE-X19) for relapsed or refractory mantle cell lymphoma, which targets the CD19 antigen on B cells. Tyrosine kinase inhibitors such as imatinib, dasatinib, and bosutinib have been approved for Philadelphia chromosome-positive acute lymphoblastic leukemia. Additionally, the FLT3 inhibitor gilteritinib has been approved for acute myeloid leukemia with FLT3 mutations. These therapies represent significant advancements in the targeted treatment of hematological malignancies.

What other types of research exist?

Promising alternatives to SG2501 for blood cancer patients include: 1) Venetoclax, particularly in combination with low-dose cytarabine, which has shown efficacy in AML. 2) Ivosidenib and Enasidenib, targeting IDH1 and IDH2 mutations respectively, for AML. 3) Gemtuzumab Ozogamicin, an antibody-drug conjugate, for older AML patients. 4) Carfilzomib, a proteasome inhibitor, for relapsed or refractory multiple myeloma. 5) Daratumumab, a monoclonal antibody, in combination regimens for multiple myeloma.

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Virus Therapy

SG2501 for Blood Cancers and Lymphoma

Phase 1

Recruiting

Research Sponsored by Hangzhou Sumgen Biotech Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Adequate hepatic function as evidenced by meeting specific requirements

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

Must not have

Known active tuberculosis

Major surgery within 4 weeks prior to study entry

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of treatment phase (24 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SG2501 to see if it is safe and effective for patients with certain blood cancers that have come back or did not respond to previous treatments. The study will find the best dose and check if the drug can help the immune system fight the cancer.

Who is the study for?

Adults with certain blood cancers or lymphoma that haven't responded to previous treatments can join this trial. They must be willing to use contraception and have a life expectancy of at least 12 weeks. Key organ functions need to be adequate, and they should not have had major surgery recently or any other serious medical conditions that could interfere with the study.

What is being tested?

SG2501 is being tested in adults with relapsed or refractory hematological malignancies and lymphoma. This early-phase trial will gradually increase doses to find safe levels, understand how the body processes the drug, check for preliminary signs of effectiveness, and explore potential biomarkers.

What are the potential side effects?

As SG2501 is a new treatment under investigation, side effects are still being studied. However, participants may experience immune reactions, infusion-related responses, fatigue, digestive issues or changes in blood counts as commonly seen with cancer therapies.

Eligibility Criteria

Inclusion Criteria

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

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My liver is functioning well.

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My blood cancer has returned or isn't responding to treatment, and I can't tolerate the usual therapies.

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My DLBCL cancer did not respond to initial or second-line treatments.

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My blood test results are within the required range.

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My kidney function meets the required standards.

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I have multiple myeloma that has returned or didn't respond to treatment, and I've had at least 3 types of treatments including a PI, a CD38 antibody, and an immunomodulatory agent.

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I can take care of myself and perform daily activities.

Exclusion Criteria

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

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I have active tuberculosis.

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I have not had major surgery in the last 4 weeks.

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I have active hepatitis.

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I have not received a live virus vaccine in the last 28 days.

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I have not had any other cancer within the last 2 years.

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I have brain metastases or tumors causing symptoms.

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I am a man and agree to use two forms of birth control.

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I have a serious heart condition that needs treatment.

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I have not had a major clotting or bleeding event in the last 6 months.

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I have lung problems that cause symptoms.

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I have been treated with specific antibodies or fusion constructs before.

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I currently have an active COVID-19 infection.

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I am HIV positive with AIDS or have a low CD4+ T cell count.

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I received a blood transfusion for my lymphoma within the last 2 weeks.

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I had a stem cell transplant from a donor within the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of treatment phase (24 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of treatment phase (24 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of treatment phase (24 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of patients with AEs and SAEs

The Maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) for SG2501

Secondary study objectives

Correlation antitumor activity

Cytokine level

Immune-cell type assessment

+5 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: SG2501Experimental Treatment1 Intervention

SG2501 monotherapy intravenous (IV) infusion - Weekly doses

0 / 22Eligibility 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

Common treatments for blood cancers often target specific pathways critical to cancer cell survival and proliferation. Tyrosine kinase inhibitors (TKIs) like imatinib and dasatinib block abnormal proteins that drive cancer growth, particularly in conditions like chronic myeloid leukemia. Monoclonal antibodies, such as rituximab, target specific antigens on cancer cells, marking them for destruction by the immune system. Chemotherapy agents, including cytarabine and daunorubicin, disrupt DNA replication and cell division, leading to cancer cell death. Immunotherapies, like CAR-T cell therapy, enhance the body's immune response against cancer cells. These mechanisms are crucial as they offer targeted approaches to eliminate cancer cells while minimizing damage to normal cells, improving patient outcomes and reducing side effects. Investigational drugs like SG2501 may offer novel mechanisms or improved efficacy and safety profiles, representing hope for more effective treatments.

Stress Granules in the Anti-Cancer Medications Mechanism of Action: A Systematic Scoping Review.Novel treatment strategies for myeloproliferative neoplasms.Emerging agents for the prevention of treatment induced neutropenia in adult cancer patients.