Actively Recruiting
MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tumors
Led by Peking University · Updated on 2023-12-14
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
P
Peking University
Lead Sponsor
S
Shanghai Ming Ju Biotechnology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.
CONDITIONS
Official Title
MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, male or female
- Willing to participate and sign informed consent
- Life expectancy of at least 12 weeks
- ECOG performance status 0 or 1 at screening and prior to treatments
- Histologically confirmed recurrent or metastatic advanced solid tumors
- Disease progression after at least one prior systemic treatment with no standard care options
- Tumor samples positive for MAGE-A4 by immunohistochemistry
- Matched for HLA-A*02 allele
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Adequate organ function
- Suitable venous access for apheresis
- Previous treatment side effects recovered to Grade 1 or less (except alopecia and peripheral neuropathy)
- Women of childbearing potential must use effective contraception from 28 days before lymphodepletion to 1 year after infusion
- Male patients with female partners of childbearing potential must use barrier contraception from lymphodepletion to 1 year after infusion; sperm donation prohibited
- Negative pregnancy test for women of childbearing potential at screening and before lymphodepletion
You will not qualify if you...
- Pregnant or lactating women
- Positive for HIV, or active hepatitis B, hepatitis C, syphilis, tuberculosis, or COVID-19
- Untreated or unstable central nervous system metastases
- Another primary cancer within 3 years, except certain early-stage tumors completely removed
- Extensive metastases or rapid tumor progression before lymphodepletion judged inappropriate for study
- Systemic autoimmune disorders requiring long-term treatment
- Prior genetically engineered T cell or other gene/cell therapy
- History of organ transplant
- Uncontrolled or active infection near treatment times
- Serious diseases limiting study participation
- Significant CNS disorders like epilepsy, stroke, or Parkinson's
- Recent significant hemorrhage or need for long-term blood thinners
- Active digestive ulcers or gastrointestinal bleeding within 3 months
- Not meeting washout period requirements for apheresis
- Allergic or intolerant to study treatment or components
- Unable or unwilling to comply with study protocol
- Other conditions judged unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of GI Oncology,Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Lin Shen
CONTACT
C
Changsong Qi
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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