NCT06515626 Genetically Modified T Cells Treating Malignant Tumors
| NCT ID | NCT06515626 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Yi Zhang |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-18 |
| Primary Completion | 2025-12 |
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 2024-08-18 with a primary completion date of 2025-12.
⚠ 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
To observe the safety, tolerability and initial effectiveness of gene modified T cell therapy in patients with malignant tumors in First Affiliated Hospital of Zhengzhou University, China.
Eligibility Criteria
Inclusion Criteria: 1. Subjects with malignant tumors confirmed by histopathology or cytology, including: non-small cell lung cancer, esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, kidney cancer, cervical squamous cell carcinoma, ovarian cancer, breast cancer, melanoma, and brain glia tumor, lymphoma, etc.; 2. Age: 18 \~ 75 years old; Gender: no limitation; 3. Have sufficient hematopoietic capacity: ANC \>1500 cells /mm3, Blood plate count \>50,000 cells /mm3, HGB \>9.0g/dL, ALC \>9 cells /mm3; 4. Adequate liver and kidney function: AST and ALT ≤2.5 ULN in patients without liver metastasis and ≤5 times in patients with liver metastasis. ULN; Bilirubin ≤1.5 ULN (excluding hyperbilirubinemia or hyperbilirubin of non-hepatic origin); Creatinine ≤2.0 ULN. Creatinine clearance and creatinine clearance hormone ≥40 mL/min; 5. PT/INR \<1.5 ULN, and PTT/αPTT \<1.5 ULN; 6. For desirable tumor tissues or tissue white tablets, positive expression of at least one of Mesothelin, NKG2D, HER2, CD276, CD19, BCMA and other antigens can be selected for clinical trials; 7. ECOG physical status score 0 \~ 2 points; 8. Expected survival \>6 months; 9. Subject accepts voluntarily Exclusion Criteria: 1. Received anti-PD1, anti-PD-L1 or anti-PD-L2 antibody therapy or other immunotherapy methods one month before treatment with immune cells in this study; 2. History of organ transplantation; 3. Pregnancy or lactation; 4. Positive for high baseline HBV DNA levels (≥2000 IU/ml), HIV antibodies (anti-HIV), hepatitis C virus antibodies (anti-HCV), or treponema pallidum antibodies; 5. There is active infection; 6. There are active brain metastases (except asymptomatic or stable brain metastases after treatment); 7. Combined with a second tumor; With the exception of patients with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid cancer who achieved complete response to the second tumor for more than 5 years and did not require treatment during the study period; 8. Severe autoimmune diseases such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or Wegener's granulomatosis require long-term (more than 2 months) systemic immunosuppressive therapy; 9. People with allergies; 10. NYHA heart failure grade ≥2 or hypertension can not be controlled after standard treatment, have a history of myocarditis or have a heart attack within one year; 11. Thrombotic diseases with active bleeding that require treatment; 12. Patients who are determined by the researcher to have a serious uncontrollable disease or other conditions that may affect the treatment in this study and are considered unsuitable.
Contact & Investigator
Yi Zhang, MD
STUDY CHAIR
The First Affiliated Hospital of Zhengzhou University
Frequently Asked Questions
Who can join the NCT06515626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying 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 NCT06515626 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 NCT06515626 currently recruiting?
Yes, NCT06515626 is actively recruiting participants. Contact the research team at yizhang@zzu.edu.cn for enrollment information.
Where is the NCT06515626 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT06515626 clinical trial?
NCT06515626 is sponsored by Yi Zhang. The principal investigator is Yi Zhang, MD at The First Affiliated Hospital of Zhengzhou University. The trial plans to enroll 100 participants.