NCT03535246 Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells
| NCT ID | NCT03535246 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shenzhen Geno-Immune Medical Institute |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 100 participants in total. It began in 2025-07-01 with a primary completion date of 2028-06-30.
⚠ 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
The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE).
Eligibility Criteria
Inclusion Criteria: * 1\. Written, informed consent obtained prior to any study-specific procedures. 2. The results of immune staining of the patient's cancer specimens positive for any one or more of tumor-associated antigens, such as GD2, mesothelin, P16, MMP, Melan A, MAGE A1, MAGE A3, and MAGE A4. 3\. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. 4. Life expectancy ≥ 3 months. 5. Able to comply with the protocol. 6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV. 7\. Not pregnant, and on appropriate birth control if of childbearing potential. 8\. Adequate bone marrow reserve with * absolute neutrophil count (ANC) ≥ 1000/mm3. * Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with * Serum creatinine ≤ 2 x upper limit of normal (ULN). * Serum bilirubin ≤ 2 x ULN. * aspartate aminotransferase (AST)/ALT ≤ 2 x ULN. * Alkaline phosphatase ≤ 5 x ULN. * Serum bilirubin. 2.0 is acceptabl
Frequently Asked Questions
Who can join the NCT03535246 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 80 Years, studying Cancer. 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 NCT03535246 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 NCT03535246 currently recruiting?
Yes, NCT03535246 is actively recruiting participants. Visit ClinicalTrials.gov or contact Shenzhen Geno-Immune Medical Institute to inquire about joining.
Where is the NCT03535246 trial being conducted?
This trial is being conducted at Guangzhou, China, Shenzhen, China, Kunming, China.
Who is sponsoring the NCT03535246 clinical trial?
NCT03535246 is sponsored by Shenzhen Geno-Immune Medical Institute. The trial plans to enroll 100 participants.
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