A Single Arm, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of B4T2-001 CAR-T in Patients With Advanced Solid Tumors
This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of autologous B4T2-001 CAR-T in subjects with advanced solid tumors including but not limited to advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, advanced pancreatic cancer, advanced non-small cell lung cancer (NSCLC), colorectal cancers (CRC) and metastatic breast cancer that tests positive for BT-001 target antigen according to Immunohistochemistry (IHC). The trial builds off first-in-human results from pilot study per clinicaltrials.gov ID: NCT05621486 to administer multiple infusions of B4T2-001 CAR-T without the need to give preparative chemotherapy (lymphodepletion).
• The subjects have been fully informed of the possible risks and benefits of participating in this study and have voluntarily signed the informed consent form (ICF).
• Age: 18-70 years (including 18 and 70 years).
• ECOG 0-1.
• With an expected survival of more than 3 months.
• Patients with histologically or cytologically confirmed locally advanced or metastatic BT-001 positive solid tumors. IHC should be within 6 months of apheresis, but maybe extended.
• Preference for patients who have failed first- or second-line therapy.
• Having measurable lesions according to RECIST 1.1 (or the latest version).
• Maximum tumor size less than 4 cm according to RECIST 1.1 (or the latest version).
• Having sufficient bone marrow, liver, kidney, and lung functions (based on the normal value of the clinical trial sites).
‣ ANC and PLT ≥ LLN.
⁃ Without liver metastases, ALT, AST, or ALP ≤ 2.5×upper limit of normal (ULN); with liver metastases, ALT, AST, or ALP ≤ 5×ULN.
⁃ Serum creatinine (ScR) ≤ 1.5×ULN, or creatinine clearance \> 50 mL/min (calculated according to Cockcroft Gault formula).
⁃ International normalized ratio (INR) ≤ 1.5×ULN, APTT ≤ 1.5×ULN.
⁃ Adequate oxygen saturation (≥ 95%) can be maintained without oxygen inhalation.
⁃ Male or female patients of childbearing potential agree to use effective methods of contraception (such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, and intrauterine devices) during the study period and within 1 year after infusion.