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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of treatment phase (24 weeks)
Awards & highlights

Study Summary

This trial is testing a new drug, SG2501, to see if it is safe and works well against relapsed or refractory hematological malignancies (cancer that starts in the blood) and lymphoma.

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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with AEs and SAEs
The Maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) for SG2501
Secondary outcome measures
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%
Nasopharyngitis
33%
Leukopenia
33%
Weight increased
29%
Back pain
29%
Thrombocytopenia
29%
C-reactive protein increased
29%
Lymphopenia
24%
Growing pains
24%
Diarrhoea
24%
Haematuria
24%
Dizziness
24%
Nausea
24%
Gamma-glutamyltransferase increased
24%
Tremor
24%
Insomnia
24%
Dyspnoea
24%
Rash
24%
Hypotension
19%
Alanine aminotransferase increased
19%
Hyperglycaemia
19%
Constipation
19%
Fibrin D dimer increased
19%
Tachycardia
19%
Weight decreased
19%
Periorbital oedema
14%
Cough
14%
Vomiting
14%
Blood potassium decreased
14%
Hyperhidrosis
10%
Monocyte count increased
10%
Neck pain
10%
Oral herpes
10%
Cystitis
10%
Arthralgia
10%
Sinusitis
10%
Myalgia
10%
Pharyngitis
10%
Blood alkaline phosphatase increased
10%
Pain in extremity
10%
Bradycardia
10%
Lacrimation increased
10%
Dry mouth
10%
Catheter site erythema
10%
Catheter site pain
10%
Bronchitis
10%
Coagulation factor XIII level increased
10%
Immunoglobulins decreased
10%
Anorexia
10%
Immunodeficiency
10%
Blood lactate dehydrogenase increased
10%
Night sweats
10%
Hypertension
5%
Convulsion
5%
Somnolence
5%
Epilepsy
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

Find a Location

Who is running the clinical trial?

Hangzhou Sumgen Biotech Co., Ltd.Lead Sponsor
5 Previous Clinical Trials
408 Total Patients Enrolled

Media Library

SG2501 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05293912 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has SG2501 received governmental sanctioning yet?

"The safety of SG2501 is judged to have a rating of 1 due to the lack of evidence from Phase 1 trials regarding its efficacy and security."

Answered by AI

To what extent is this medical experiment impacting the number of participants?

"Indeed, the information posted on clinicaltrials.gov verifies that this experiment is actively recruiting subjects. This trial was first announced on August 3rd 2022 and has since been updated; it requires 72 participants from a single site."

Answered by AI

What is the fundamental purpose of this research?

"The primary goal of the 24 week trial is to ascertain SG2501's Maximum Tolerated Dosage (MTD) and Recommended Phase 2 Dosage (RP2D). Secondary objectives include evaluating its Pharmacokinetics, assessing Preliminary Anti-Tumor Activity through Objective Response Rates, and measuring Immunogenicity via the number of patients with ADAs."

Answered by AI

Is enrollment for this research program ongoing?

"According to information posted on clinicaltrials.gov, this medical study began recruiting participants in August 2022 and remains open for enrollment at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
SG2501 Safety Study in Subjects With Relapsed or Refractory Hematological Malignancies and Lymphoma.
2022. "SG2501 Safety Study in Subjects With Relapsed or Refractory Hematological Malignancies and Lymphoma.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05293912.
~21 spots leftby Dec 2024
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