Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of ESO-T01 in Treating Relapsed/Refractory Multiple Myeloma.
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-03-25
24
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
U
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of ESO-T01 for patients with relapsed/refractory multiple myeloma.
CONDITIONS
Official Title
A Clinical Study to Evaluate the Safety and Efficacy 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 cancer cells
- Previously treated with at least 2 lines of therapy, with disease progression within 12 months or refractory to key treatments with progression within 2 months
- Measurable disease by defined laboratory or clinical criteria
- ECOG performance status 0-2 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 at least 40%, no significant pericardial effusion or ECG abnormalities
- Pulmonary function with oxygen saturation 90% or higher and no significant pleural effusion
- Women of childbearing potential must have a negative pregnancy test and not be breastfeeding
- Agreement to use contraception for 1 year post-treatment for men and women of childbearing potential
- Agreement to avoid donating reproductive cells for 1 year post-treatment
- Ability to provide written informed consent
You will not qualify if you...
- Recent treatments including targeted therapy, investigational drugs, systemic therapies, cytotoxic therapy, proteasome inhibitors, immunomodulatory agents, or radiotherapy within specified time frames
- Allogeneic stem cell transplant within 6 months or autologous transplant within 3 months prior to infusion
- Other malignancies unless treated successfully and disease-free for over 2 years or adequately treated non-melanoma skin cancer
- Prior viral therapy using VSVG pseudotype virus
- Serious uncontrolled infections
- Positive tests for hepatitis B or C with active viral replication, HIV, or syphilis
- Severe heart conditions including NYHA class III or IV heart failure, recent heart attack or surgeries, significant arrhythmias, or cardiomyopathy
- Other serious diseases including primary immunodeficiency, recent stroke or seizure, dementia, Parkinson's disease or parkinsonism
- Recent surgery within 2 weeks before or planned within 2 weeks after treatment except minor procedures
- Use of live vaccines within 1 month before treatment
- Known severe allergic reactions to ESO-T01, its components, or Tocilizumab
- Inability to establish venous access
- Any condition judged by the investigator to make participation unsafe or unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
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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