Genetically modified T cells for treating malignant tumors

Clinical Study to Evaluate the Safety and Efficacy of Genetically Modified T Cells in the Treatment of Malignant Tumors

This study is testing a new type of treatment using modified T cells to see if it can help people with different types of cancer feel better and live longer.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06515626 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and initial effectiveness of CAR-T cell therapy in patients with various malignant tumors, including lung, gastric, colorectal, and breast cancers. Participants will undergo CAR-T cell reinfusion, and the study will monitor progression-free survival, overall survival, disease control rate, clinical benefit rate, and quality of life. Additionally, the research will explore changes in T cell receptor diversity, lymphocyte subsets, immune cell function, and serum cytokine levels following treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed malignant tumors and adequate hematopoietic, liver, and kidney function.

Not a fit: Patients with tumors not listed in the eligibility criteria or those with significant comorbidities affecting treatment tolerance may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a novel and effective treatment option for patients with malignant tumors.

How similar studies have performed: Other studies utilizing CAR-T cell therapy have shown promising results in treating certain cancers, indicating potential for success in this approach.

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.

Where this trial is running

Zhengzhou, Henan

• Zhengzhou University First Affiliated Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Yi Zhang, MD

Conditions Solid Tumor; CAR