Phase I Clinical Trial of New CoupidCAR Therapy GCC19CART for Refractory Solid Tumors

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What is CAR-T Cell Therapy?

CAR-T therapy (Chimeric Antigen Receptor T-cell therapy) is a type of immunotherapy primarily used for the clinical treatment of malignant blood diseases and tumors. CAR-T therapy involves collecting and isolating T cells from the patient’s blood, followed by genetic modification to enhance their targeting and killing abilities against cancer cells. After large-scale culture and amplification of T cells in vitro, they are reintroduced into the patient’s body, continuing to proliferate and ultimately recognizing and destroying cancer cells within the body.

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CAR-T therapy is more lethal to tumor cells and has stronger targeting capabilities, resulting in more durable treatments. Each CAR-T is specifically designed based on the surface antigens of the tumor present in the patient’s body, making it more targeted. Experiments have shown that when cancer cells re-emerge in the body, these genetically modified T cells can still exert anti-tumor activity.

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Clinical Project Information on CAR-T Therapy

[Research Title]Phase I Clinical Trial of New CoupidCAR Therapy GCC19CART for Refractory Solid Tumors[Research Drug]

Chimeric Antigen Receptor T-cell Immunotherapy

[Project Advantages]This clinical trial utilizes CAR-T cell therapy; Efficacy: Currently, there have been cases of PR (Partial Response), with colorectal cancer (40%-90%), thyroid cancer (70%), and higher rates for prostate cancer;[Eligible Cancers]Patients with solid tumors who have failed standard treatments can participate; Patients with gastric cancer, breast cancer, pancreatic cancer, lung cancer, mesothelioma, ovarian cancer, endometrial cancer, cervical cancer, prostate cancer, and other solid tumors can participate.

[Inclusion Criteria]

1. Aged 18-65;

2. Immunohistochemistry (IHC) target expression ≥1+;

3. Cytology or pathology confirmed solid tumor meeting the protocol;

4. Inoperable or unsuitable for surgery, or postoperative recurrence;

5. At least one measurable extra-cranial lesion according to RECIST 1.1 criteria;

6. Expected survival ≥60 days;

7. Major organ function normal, meeting the following criteria:

8. ECOG score 0-1 or KPS score >70;

9. Blood test standards: HB≥90g/L (not transfused in the last 14 days), ANC≥ 1.5 x 10^9/L, PLT≥80 x 10^9/L, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×ULN (upper limit of normal);

10. Biochemical tests: TBIL≤1.5 x ULN (upper limit of normal); ALT and AST≤2.5 x ULN; if liver metastasis exists, ALT and AST≤5xULN; serum Cr≤1xULN, endogenous creatinine clearance >50 ml/min (Cockcroft-Gault formula);

11. Cardiac ejection fraction >55%;

12. No bleeding disorders or coagulation dysfunction;

13. No allergy to contrast agents;

14. (Women of childbearing age) Negative pregnancy test results and contraception within 8 weeks after the last infusion;

15. Good compliance and cooperation with follow-up.

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[Exclusion Criteria]

1. T-cell transduction efficiency <10% or T-cell expansion less than 5-fold after culture;

2. Participation in other drug clinical trials within 4 weeks prior to the study start;

3. Patients with hypertension poorly controlled by a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure >90 mmHg), patients with grade I or higher myocardial ischemia or myocardial infarction, grade I and above arrhythmias (including QT interval ≥ 440ms) or heart failure;

4. Long-term non-healing wounds in the chest or other areas or fractures;

5. History of substance abuse and inability to quit or history of mental disorders;

6. Objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severely impaired lung function;

Presence of uncontrolled or antibiotic-treated fungal, bacterial, viral, or other infections. Simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed;

[Research Hospital Locations]

Chongqing, Changchun, Zhengzhou, Lanzhou, Yantai, Shanghai, Qingdao

END, click the link below to learn more about previous exciting content

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2. Why Cancer Patients Are Suitable for Clinical Trials

3. DN1508052-01 Monotherapy Subcutaneous and Intratumoral Injection Clinical Treatment for Advanced Solid Tumor Patients

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