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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

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 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

Side effects data

From 2014 Phase 2 trial • 21 Patients • NCT00560794
100%
Pyrexia
67%
Blood immunoglobulin A decreased
62%
Blood immunoglobulin G decreased
48%
Blood immunoglobulin M decreased
48%
Hypokalaemia
48%
Headache
43%
Chills
38%
Fatigue
38%
Oedema peripheral
33%
Leukopenia
33%
Nasopharyngitis
33%
Weight increased
29%
Thrombocytopenia
29%
C-reactive protein increased
29%
Back pain
29%
Lymphopenia
24%
Diarrhoea
24%
Nausea
24%
Gamma-glutamyltransferase increased
24%
Growing pains
24%
Dizziness
24%
Tremor
24%
Insomnia
24%
Haematuria
24%
Dyspnoea
24%
Rash
24%
Hypotension
19%
Tachycardia
19%
Constipation
19%
Alanine aminotransferase increased
19%
Fibrin D dimer increased
19%
Weight decreased
19%
Hyperglycaemia
19%
Periorbital oedema
14%
Vomiting
14%
Blood potassium decreased
14%
Cough
14%
Hyperhidrosis
10%
Bradycardia
10%
Lacrimation increased
10%
Dry mouth
10%
Catheter site erythema
10%
Catheter site pain
10%
Immunodeficiency
10%
Bronchitis
10%
Cystitis
10%
Oral herpes
10%
Pharyngitis
10%
Sinusitis
10%
Blood alkaline phosphatase increased
10%
Blood lactate dehydrogenase increased
10%
Coagulation factor XIII level increased
10%
Immunoglobulins decreased
10%
Monocyte count increased
10%
Anorexia
10%
Arthralgia
10%
Myalgia
10%
Neck pain
10%
Pain in extremity
10%
Night sweats
10%
Hypertension
5%
Convulsion
5%
Epilepsy
5%
Somnolence
5%
Syncope
5%
Bacterial sepsis
5%
Bronchopneumonia
5%
Catheter related infection
5%
Escherichia sepsis
5%
Medical device complication
5%
Thrombosis in device
100%
80%
60%
40%
20%
0%
Study treatment Arm
Blinatumomab

Trial Design

1Treatment groups
Experimental Treatment
Group I: SG2501Experimental Treatment1 Intervention
SG2501 monotherapy intravenous (IV) infusion - Weekly doses

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.

Find a Location

Who is running the clinical trial?

Hangzhou Sumgen Biotech Co., Ltd.Lead Sponsor
6 Previous Clinical Trials
768 Total Patients Enrolled

Media Library

SG2501 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05293912 — Phase 1
~8 spots leftby Dec 2024
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