Status:
RECRUITING
MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tumors
Lead Sponsor:
Peking University
Collaborating Sponsors:
Shanghai Ming Ju Biotechnology Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
This study is a single-arm, open-label, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of T-cell receptor-engineered T cell (TCR-T) targeting melanoma-associated ...
Eligibility Criteria
Inclusion
- 18-75 year-old, male or female
- Voluntarily willing to participate in the study and sign the written informed consent form
- Life expectation ≥12 weeks
- European Cooperative Oncology Group (ECOG) ≤1 at screening, 24 hours prior to apheresis (APH), lymphodepletion (LD), and infusion
- Histologically-confirmed recurrent/metastatic advanced solid tumors
- Radiologically-confirmed progression disease after at least one prior line of systematic treatment and no available standard of care at screening, judged by investigators
- Fresh or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained MAGE-A4 positive
- Human leukocyte antigen (HLA)-A\*02 allele matched
- Per response evaluation criteria in solid tumors (RECIST) version 1.1, at least one measurable lesion
- Adequate organ functions
- Adequate venous access for APH
- Non-hematological adverse events induced by previous treatment must have recovered to Grade ≤1 according to Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia and peripheral neuropathy
- Women of childbearing potential must agree to use an effective and reliable contraceptive method during 28 days prior to lymphodepletion to 1 year post infusion; Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive method since lymphodepletion to 1 year post infusion, and sperm donation is prohibited during the study
- Women of childbearing potential must have negative serum human chorionic gonadotropin β (β-hCG) test result at screening and 48 hours prior to lymphodepletion
Exclusion
- Pregnant or lactating women
- Human immunodeficiency virus (HIV) serology positive, or active hepatitis B virus (HBV)/hepatitis C virus (HCV)/Syphilis/Tuberculosis/ Coronavirus disease 2019 (COVID-19)
- Central nerve system (CNS) metastasis must have received treatment and been neurologically stable for ≥2 months, not requiring anti-seizure medications and off steroids for ≥ 1 month prior to APH
- Another primary malignancy within 3 years (with some exceptions for completely-resected early-stage tumors)
- Subjects with extensive metastases, or more rapid tumor progression prior to lymphodepletion in comparison to screening, etc. which might not be appropriate for further study treatment judged by the investigators
- Systematic autoimmune disorders requiring long-term systematic treatment
- Previously treated with any genetically engineered modified T cell therapy or other cell and gene therapy (CGT)
- History of organ transplant
- Uncontrolled or active infection within 72 hours prior to screening, APH, LD, or within 5 days prior to infusion
- Subjects with other serious diseases that may restrict them from participating in this study
- Clinically significant CNS disorders, such as epilepsy, stroke, Parkinson disease, etc
- Grade ≥ 2 hemorrhage within 30 days prior to screening, or in need of longterm anticoagulants
- Active digestive ulcer or gastrointestinal (GI) bleeding within 3 months prior to screening
- Not satisfying wash-out period for APH
- Previously allergic or intolerable to JWTCR001 or its components
- Unable or unwilling to comply with the study protocol, judged by the investigators
- Other situations implying that the subject might not be appropriate to participate in the study
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06170294
Start Date
January 1 2024
End Date
December 31 2028
Last Update
December 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of GI Oncology,Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142