Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT05166070

An Exploratory Clinical Study of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2021-12-21

24

Participants Needed

1

Research Sites

782 weeks

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital with Nanjing Medical University

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

An Exploratory Clinical Study of RD133 in Subjects With Relapsed or Refractory MSLN-Positive Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before starting the study
  • Age 18 years or older
  • Received at least two prior standard treatments without response to last treatment
  • Tumor shows more than 25% mesothelin positivity by immunohistochemistry
  • Expected survival of at least 12 weeks
  • ECOG performance status 0 to 2
  • At least one measurable target lesion meeting RECIST v1.1 criteria
  • Agree to use effective contraception from consent until 365 days post-infusion if of reproductive potential
  • Adequate organ function including neutrophils 21.0 x 10^9/L, platelets 25 x 10^9/L, hemoglobin 9 g/dl, bilirubin 1.5 times upper limit normal (except tumor-related bile duct obstruction), creatinine clearance 260 ml/min, ALT/AST 2.5 times upper limit normal (up to 5 times with liver involvement), cardiac ejection fraction 25%, stable coagulation, and oxygen saturation 291% in room air
Not Eligible

You will not qualify if you...

  • Acute or chronic graft-versus-host disease requiring systemic treatment within 4 weeks
  • Prior gene therapy
  • Need for systemic immunosuppressive therapy for autoimmune or immunodeficiency diseases within 2 years
  • Live vaccine injection within 4 weeks
  • Participation in other interventional drug trials within 12 weeks before apheresis
  • Central metastasis or complete intestinal obstruction
  • Moderate or severe hydrothorax or ascites requiring continuous drainage
  • Active malignant tumor in past 5 years except certain cured tumors
  • Positive for hepatitis B or C, HIV, CMV, or syphilis with abnormal test results
  • Uncontrolled active infection except mild genitourinary or upper respiratory infections
  • Severe heart disease including recent myocardial infarction or severe arrhythmia
  • Uncontrolled hypertension
  • Unresolved toxicity from prior treatments greater than grade 1 (except hair loss or insignificant labs)
  • Major surgery within 2 weeks before enrollment or planned surgery during or within 12 weeks after RD133 infusion (except local anesthesia)
  • Solid organ transplant
  • Pregnant or breastfeeding women
  • History of central nervous system diseases or mental disorders
  • Unstable severe systemic diseases requiring medication
  • Known severe allergic reactions or intolerance to RD133 or its components
  • Severe bleeding or thrombosis disorders or receiving anticoagulant therapy
  • Other conditions deemed unsuitable by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

L

Lingxiang Liu

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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