Actively Recruiting
Safety and Efficacy of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors
Led by Tongji Hospital · Updated on 2022-04-27
24
Participants Needed
1
Research Sites
772 weeks
Total Duration
On this page
Sponsors
T
Tongji Hospital
Lead Sponsor
S
Shanghai IASO Biotechnology Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-center exploratory clinical trial. It is estimated that 9-24 subjects will be enrolled. The "3+3" dose escalation design is adopted. The main purpose is to evaluate the safety of RD133 in the treatment of subjects with relapsed or refractory MSLN-positive solid tumors and explore the Recommend phase II dose of RD133 in the treatment of patients with relapsed/refractory MSLN-positive solid tumors.
CONDITIONS
Official Title
Safety and Efficacy of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must personally sign the written informed consent form approved by the ethics committee before starting the study
- Age 18 years or older
- Have received at least two prior standard treatments without response to the last treatment
- Tumor tissue or freshly punctured tissue shows more than 25% mesothelin positive rate on tumor cell membrane by immunohistochemistry
- Expected survival of at least 12 weeks
- ECOG performance status score of 2 or less
- At least one measurable target lesion meeting RECIST v1.1 criteria
- Agree to use effective contraception or abstain from sexual activity from signing consent until 365 days after infusion
- Adequate organ function as shown by specified blood counts, liver and kidney function tests, heart function, coagulation, and oxygen saturation levels
You will not qualify if you...
- History of acute or chronic graft-versus-host disease requiring systemic treatment within 4 weeks prior to enrollment
- Prior gene therapy
- Need for systemic immunosuppressive therapy (except topical) for autoimmune or immunodeficiency diseases within 2 years after enrollment
- Live vaccine injection within 4 weeks before enrollment
- Use of other interventional clinical trial drugs within 12 weeks before apheresis
- Central nervous system metastasis or complete intestinal obstruction
- Moderate or severe pleural effusion or ascites that is difficult to control and requires continuous drainage
- Active malignant tumor within past 5 years except certain cured tumors
- Positive tests for hepatitis B, hepatitis C, HIV, cytomegalovirus, or syphilis infections
- Uncontrolled active infection except mild genitourinary or upper respiratory infections
- Severe heart disease including unstable angina, recent myocardial infarction, heart failure NYHA grade 3 or higher, or severe arrhythmia
- Uncontrolled hypertension
- Unresolved toxicity from prior treatment above grade 1 except hair loss or clinically insignificant lab abnormalities
- Major surgery within 2 weeks before enrollment or planned surgery during treatment or within 12 weeks after infusion (except local anesthesia)
- History of solid organ transplant
- Pregnant or breastfeeding women
- History of central nervous system diseases or mental disorders
- Other unstable systemic diseases requiring medication
- Known life-threatening allergic reactions or intolerances to RD133 or its components
- History of severe bleeding or thrombosis or currently receiving blood thinning treatments
- Any other conditions judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Q
Qinglei Gao, MD. PhD
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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