NCT06170294 MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tumors
| NCT ID | NCT06170294 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Peking University |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 tumors.
Eligibility Criteria
Inclusion Criteria: 1. 18-75 year-old, male or female 2. Voluntarily willing to participate in the study and sign the written informed consent form 3. Life expectation ≥12 weeks 4. European Cooperative Oncology Group (ECOG) ≤1 at screening, 24 hours prior to apheresis (APH), lymphodepletion (LD), and infusion 5. Histologically-confirmed recurrent/metastatic advanced solid tumors 6. Radiologically-confirmed progression disease after at least one prior line of systematic treatment and no available standard of care at screening, judged by investigators 7. Fresh or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained MAGE-A4 positive 8. Human leukocyte antigen (HLA)-A\*02 allele matched 9. Per response evaluation criteria in solid tumors (RECIST) version 1.1, at least one measurable lesion 10. Adequate organ functions 11. Adequate venous access for APH 12. 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 13. 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 14. 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 Criteria: 1. Pregnant or lactating women 2. Human immunodeficiency virus (HIV) serology positive, or active hepatitis B virus (HBV)/hepatitis C virus (HCV)/Syphilis/Tuberculosis/ Coronavirus disease 2019 (COVID-19) 3. 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 4. Another primary malignancy within 3 years (with some exceptions for completely-resected early-stage tumors) 5. 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 6. Systematic autoimmune disorders requiring long-term systematic treatment 7. Previously treated with any genetically engineered modified T cell therapy or other cell and gene therapy (CGT) 8. History of organ transplant 9. Uncontrolled or active infection within 72 hours prior to screening, APH, LD, or within 5 days prior to infusion 10. Subjects with other serious diseases that may restrict them from participating in this study 11. Clinically significant CNS disorders, such as epilepsy, stroke, Parkinson disease, etc 12. Grade ≥ 2 hemorrhage within 30 days prior to screening, or in need of longterm anticoagulants 13. Active digestive ulcer or gastrointestinal (GI) bleeding within 3 months prior to screening 14. Not satisfying wash-out period for APH 15. Previously allergic or intolerable to JWTCR001 or its components 16. Unable or unwilling to comply with the study protocol, judged by the investigators 17. Other situations implying that the subject might not be appropriate to participate in the study
Contact & Investigator
Lin Shen
PRINCIPAL INVESTIGATOR
Peking University Cancer Hospital & Institute
Frequently Asked Questions
Who can join the NCT06170294 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06170294 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06170294 currently recruiting?
Yes, NCT06170294 is actively recruiting participants. Contact the research team at linshenpku@163.com for enrollment information.
Where is the NCT06170294 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06170294 clinical trial?
NCT06170294 is sponsored by Peking University. The principal investigator is Lin Shen at Peking University Cancer Hospital & Institute. The trial plans to enroll 20 participants.