A Single-center, Open-label, Single-arm Clinical Study of the Safety and Efficacy of KD-496 CAR-T Therapy in Advanced NKG2DL+/CLDN18.2+ Solid Tumors

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D/CLDN18.2-based CAR-T cells infusion in the treatment of advanced NKG2DL+/CLDN18.2+ solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

⁃ 1\. Patients diagnosed as advanced solid tumors histopathologically or cytologically, such as gastric cancer and pancreatic cancer. 2. Patients fail standard treatment , or cannot tolerate standard treatment, or there is no standard treatment, the standard treatment recommendations refer to the latest version of the guidelines of the national comprehensive cancer network (NCCN) or the guidelines of the Chinese society of Clinical Oncology (CSCO); 3. Age 18-75 years; 4. ECOG score 0-1; 5. Expected survival ≥ 3 months; 6. Patients must meet coagulation parameters and have adequate peripheral venous access for apheresis, and must also have enough PBMC to manufacture CAR T cells; 7. NKG2DL/CLDN18.2 (according to the positive comprehensive score of 0-12 points, positive SCORE of NKG2DL and CLDN18.2 ≥5) positive confirmed by Immunohistochemistry. Biopsy tissue must be no more than 2 year, if not, must obtain new tissue material from a recent surgical or diagnostic biopsy; 8. Eligible organ and bone marrow functions defined as follows:

• Absolute neutrophil count ≥1.5×10\^9/L, lymphocyte count ≥0.5×10\^9/ L, platelet count ≥90×10\^9/L, hemoglobin ≥90g/L (no blood transfusion or Erythropoietin within 7 days);

• Total bilirubin ≤1.5ULN; (Patients with Gilbert syndrome were diagnosed with total bilirubin ≤3mg/dL) Serum alanineamino transferase (ALT) or aspartate aminotransferase(AST)≤3ULN(ALT and AST in patients with liver metastases ≤5ULN);

• Creatinine ≤1.5ULN or eGFR≥60mL /min(Cockcroft and Gault)

• International normalized ratio (INR) ≤1.2;

• Lung function: ≤ grade 1 dyspnea(according to NCI-CTCAE V5.0), SaO2≥91%;

• Cardiac function:

⁃ Cardiac ejection fraction (LVEF) detected by echocardiography or MUGA ≥50% 1 month before enrollment. 9. Patients must have measurable lesions as defined by RECIST 1.1; 10. If the patient is HBsAg positive or HBcAb positive, HBV-DNA should be \< 2000IU/ml. HBsAg positive patients.Antiviral therapy must be received according to the Chronic Hepatitis B Prevention and Treatment Guidelines 2019.

• Patients fully understand the test and voluntarily sign the informed consent; 12. Patient agree to use approved contraceptive methods (e.g., birth control pills, barrier devices, iuds, contraindicated drugs) during the study and for at least 13 months after last cell infusion, until no CAR-T cells were detected by two consecutive PCR tests.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2022-10-13
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 18
Treatments
Experimental: KD-496 cell infusion
Each subject will receive KD-496 cell infusion
Related Therapeutic Areas
Sponsors
Collaborators: KAEDI
Leads: jianming xu

This content was sourced from clinicaltrials.gov

Similar Clinical Trials