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Tests treatment safety and results for Cancer
Official title Safety and Efficacy of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors
ClinicalTrials.gov ID: NCT05141253
What this study is testing
What is RD133?
RD133 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-center exploratory clinical trial. It is estimated that 9-24 subjects will be enrolled.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject must personally sign the written informed consent form approved by the ethics committee before the start of the study;
- 2.≥18 years of age;
- Have received at least 2 prior standard treatments, and achieved no response to the last-line treatment;
- \>25% Mesothelin positive rate on tumor cell membrane confirmed by prior immunohistochemistry of tumor tissue or freshly punctured tissue;
- Expected survival ≥ 12 weeks;
You likely can't join if
- Subject who has received any of the following prior treatments: 1.1 Subject with acute or chronic graft-versus-host disease (GVHD) who need systemic...
- Subject with central metastasis or complete intestinal obstruction;
- Subject with moderate or more severe hydrothorax and ascites which are hard to control by conventional treatment and require continuous catheter...
- With an active malignant tumor in the past 5 years, unless it is a curable tumor and has been obviously cured, such as basal or squamous cell...
- Subject with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and abnormal HBV DNA test results in peripheral...
- With an uncontrollable active infection (except genitourinary system infection and upper respiratory tract infection \<CTCAE Grade 2).
See the full eligibility criteria
- The subject must personally sign the written informed consent form approved by the ethics committee before the start of the study;
- 2.≥18 years of age;
- Have received at least 2 prior standard treatments, and achieved no response to the last-line treatment;
- \>25% Mesothelin positive rate on tumor cell membrane confirmed by prior immunohistochemistry of tumor tissue or freshly punctured tissue;
- Expected survival ≥ 12 weeks;
- ECOG score ≤ 2;
- At least one measurable target lesion that meets the RECIST v1.1 standard;
- Female or male people with fertility should agree to practice an effective method of contraception from the day of signing the ICF until 365 days after the infusion. Effective method of contraception is defined as...
- Before being enrolled in the group, the subject must have proper organ function and meet all of the following criteria: 9.1 The absolute value of neutrophils≥1.0×10\^9/L (granulocyte colony stimulating factor (G-CSF)...
- Subject who has received any of the following prior treatments: 1.1 Subject with acute or chronic graft-versus-host disease (GVHD) who need systemic treatment within 4 weeks before enrollment; 1.2 Subject who has...
- Subject with central metastasis or complete intestinal obstruction;
- Subject with moderate or more severe hydrothorax and ascites which are hard to control by conventional treatment and require continuous catheter drainage;
- With an active malignant tumor in the past 5 years, unless it is a curable tumor and has been obviously cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.
- Subject with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and abnormal HBV DNA test results in peripheral blood(abnormal HBV DNA test results are defined as: HBV DNA quantitative...
- With an uncontrollable active infection (except genitourinary system infection and upper respiratory tract infection \<CTCAE Grade 2).
- Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ grade 3), severe...
- Subject with hypertension that cannot be controlled by medication.
- The toxicity of previous treatment has not been relieved to baseline or ≤1(NCI-CTCAE v5.0, except for hair loss and laboratory abnormalities without clinical significance).
- Major surgery within 2 weeks before enrollment, or has surgery planned during the time the subject is expected to be infused with RD133 or within12 weeks after RD133 infusion (except planned surgery under local...
- Subject who has a solid organ transplant.
- Women who are pregnant or breastfeeding.
- Subject with previous central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, mental illness, etc.) or mental disorders.
- Other unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney, or metabolic diseases that require medication.
- Known to have life-threatening allergic reactions, hypersensitivity reactions or intolerances to RD133 cell preparations or its components.
- Subject with hemorrhage, severe thrombosis judged by the Investigator, or hereditary/acquired hemorrhage and severe thrombosis (including hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.), or are...
- The researcher believes that other situations are not suitable for inclusion in the group.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.