Actively Recruiting
A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma
Led by Chunrui Li · Updated on 2025-02-11
24
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
C
Chunrui Li
Lead Sponsor
S
Shenzhen Pregene Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single center, single arm, open-label, dose-escalation clinical study to observe the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics of ESO-T01 injection for treating patients with relapsed/refractory multiple myeloma.
CONDITIONS
Official Title
A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed diagnosis of multiple myeloma with BCMA expression on myeloma cells
- Previously treated with at least two lines of anti-myeloma therapy with disease progression as defined
- Measurable disease at screening with serum or urinary M-protein or abnormal serum free light chain ratio
- ECOG performance status 0 to 2 with expected survival of at least 3 months
- Adequate bone marrow function including hemoglobin, neutrophils, platelets, lymphocytes, and CD3-positive T cells
- Normal kidney function with creatinine clearance of 45 mL/min or higher
- Liver function within specified limits for ALT, AST, bilirubin, alkaline phosphatase, and albumin
- Cardiac function including left ventricular ejection fraction of 40% or higher and no significant ECG or pericardial issues
- Pulmonary function with oxygen saturation of 90% or higher and no significant pleural effusion
- For women of childbearing potential, negative pregnancy test and not breastfeeding
- Agreement to use effective contraception during study and for 1 year after treatment
- Agreement not to donate reproductive cells during study and for 1 year after treatment
- Ability to provide written informed consent
You will not qualify if you...
- Recent anticancer treatments within specified time frames including targeted therapies, immune therapies, cytotoxic therapies, and radiotherapy
- Allogeneic stem cell transplant within 6 months or autologous transplant within 3 months prior to infusion
- Other active malignancies except certain treated cancers without disease for 2 years
- Previous treatment with viral therapies using VSVG pseudotype virus
- Serious uncontrolled infections
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis with active infection
- Significant heart conditions including symptomatic heart failure, recent heart attacks, or serious arrhythmias
- Other serious diseases such as primary immunodeficiency, recent stroke or seizures, dementia, or Parkinson's disease
- Recent surgery within 2 weeks before or planned within 2 weeks after treatment
- Use of live vaccines within 1 month before treatment
- Known severe allergic reactions to ESO-T01 or Tocilizumab
- Inability to establish venous access
- Any other condition considered unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital, Tongji Medical College
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
C
Chunrui Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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