advanced solid tumors
Conditions
Interventions
Dose escalation group:PM3002 injection
Dose expansion group:PM3002 injection
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research, fully understand this research and voluntarily sign an informed consent form, willing to follow and have the ability to complete all trial procedures; 2. No gender limit, aged from 18 to 70 years (including boundary value); 3. HER2 positive confirmed by histology or cytology has no standard treatment plan or intolerance to standard treatment plan or subjects with advanced malignant solid tumors who failed or progressed after second-line standard treatment (such as breast cancer, gastric cancer, ovarian cancer, colorectal cancer, etc.); 4. All toxic reactions caused by previous anti-tumor treatments are alleviated to grade 0-1 (according to NCI CTCAE version 5.0) or to a level acceptable for inclusion/exclusion criteria, alopecia, vitiligo, and other toxicities considered by researchers that do not pose a safety risk to the subjects are excluded; 5. All subjects are required to provide tumor tissue specimens, which must be qualified archived specimens within 12 months before signing the informed consent form or fresh biopsy specimens collected within 9-12 weeks before cell reinfusion (Bone biopsy specimens are not accepted); 6. Sufficient organ function (without receiving medical support such as granulocyte colony stimulating factor transfusion within 14 days before cell reinfusion) is defined as follows: blood system neutrophil count (ANC) >= 1.5x10^9/L, white blood cell (WBC) ) >=3.0x10^9/L, platelet count (PLT) >=100x10^9/L, hemoglobin (Hb) >=90g/L, liver function total bilirubin (TBIL) = 50 ml/min (Cockcroft-Gault formula: ([140-age] x weight [kg] x [0.85, for women only])/(72 x creatinine (mg /dl))); qualitative urine protein = 2+, a 24-hour urine protein quantitative test is required, if 24-hour urine protein quantitative = 12 weeks; 9. According to the RECIST 1.1 standard, there is at least one measurable lesion, a lesion that has received local radiotherapy in the past can only be considered as a measurable lesion if there is clear disease progression after radiotherapy and the previously irradiated lesion is not the only measurable lesion; 10. After evaluation, enough PBMC cells can be collected from the subject to prepare reinfusion cells; 11. After evaluation, the number of prepared reinfusion cells is sufficient and the quality is qualified, which can be used for clinical reinfusion; 12. Female subjects with fertility had negative blood pregnancy results within 3 days before the cell reinfusion, and were willing to maintain abstinence or take medically approved high-efficiency contraceptive measures (such as intrauterine devices, condoms) from the time of signi
Exclusion criteria
Exclusion criteria: 1. History of severe allergic disease history of allergies to serious drugs (including unmarketed test drugs) or known allergies to any component of the drugs recommended for this program (including pretreatment drugs); 2. Patients who have received gene therapy or cell therapy or tumor vaccine in the past; 3. Patients who have undergone coronary artery reconstruction in the past; 4. Past anti-HER2 treatment has experienced serious adverse events related to the treatment drug or adverse events leading to discontinuation of the drug; 5. Evidence of major coagulopathy or other obvious risk of bleeding: (1) Past history of intracranial hemorrhage or intraspinal hemorrhage; (2) Tumor lesions invade large blood vessels and have obvious bleeding risk; (3) Thrombosis or embolism occurred within 6 months before the cell reinfusion; (4) Clinically significant hemoptysis or tumor hemorrhage occurred within 1 month before the cell reinfusion; (5) Anticoagulant therapy for therapeutic purposes (except low molecular weight heparin) has been used within 2 weeks before cell reinfusion; (6) Within 10 days before cell reinfusion, have used antiplatelet drugs, such as aspirin (>325 mg/day), clopidogrel (>75 mg/day), dipyridamole, ticlopidine or siroline Tazol, etc.; 6. Have received the following treatments or drugs before cell reinfusion: (1) There are unhealed wounds, ulcers or fractures within 28 days before the cell reinfusion; (2) Inoculated with live attenuated vaccine within 28 days before cell reinfusion; (3) Within 28 days before cell reinfusion, have received chemotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments (except for the treatments that meet the requirements of the plan before reinfusion), or treatment of any unmarketed trial drug; the following conditions also need to exclude: received nitrosourea or mitomycin C treatment within 6 weeks before cell reinfusion, received oral fluorouracil and small molecule targeted drug treatment 2 weeks before cell reinfusion or within 5 half-lives of the drug (whichever is the longer), and received Chinese medicine with anti-tumor indications within 2 weeks before cell reinfusion treat; (4) Within 2 weeks before cell reinfusion, have received corticosteroids, or it is expected that corticosteroid treatment may be required during blood collection, cell collection or cell reinfusion, except for the following situations: short time (<=7 days), doses not higher than 10 mg/d of prednisone or equivalent doses of corticosteroids are used to prevent or treat non-autoimmune conditions, corticosteroids for topical, intranasal, intraocular, intra-articular or inhaled use; 7. Known to have metastasis to the pia mater, or uncontrollable or symptomatic central nervous system metastasis, manifested as clinical symptoms, cerebral edema, spinal cord compression and/or progressive growth, and a history of central nervous system metastasis or spinal cord compression Subjects who have clearly received treatment and stopped anticonvulsants and steroids for 8 weeks before cell reinfusion are determined by the investigator to have stable clinical manifestations, they can be accepted; 8. There is any form of primary immunodeficiency; 9. There is any active autoimmune disease, or a history of autoimmune disease and expected recurrence (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, uveitis, enteritis, hepati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dose-limiting toxicity within 28 days after the first administration;Disease control rate;Objective response rate; | — |
Countries
China
Contacts
Public ContactXu Qing
Shanghai Tenth People's Hospital
Outcome results
None listed