Clinical trialPhase 1Active not recruiting
A Clinical Study to Evaluate B4T2-001 CAR T Cells in the Treatment of Advanced Solid Tumors
A FIH, Single Arm, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Autologous CAR T Cells Targeting BT-001 in Patients With Advanced Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Active not recruiting
- Study type
- Interventional
- Start
- 14 September 2022
- Expected end
- 31 December 2026
- Enrollment
- 36 participants
- Sites
- 2
- Primary outcomes
- Incidence of serious adverse events (SAEs), incidence and severity of adverse events (AEs); To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of B4T2-001 CAR T cells
- Sponsor
- Other
- Results posted
- No
- Last update
- 12 October 2023
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Brief summary public domain (ClinicalTrials.gov)
This is a first in human (FIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of B4T2-001 Autologous CAR T cells 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).
Detailed description public domain (ClinicalTrials.gov)
This is an open-label dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of B4T2-001 Autologous CAR T cells in subjects with BT-001 expressing advanced solid tumors. Patients who meet the eligibility criteria will receive B4T2-001 CAR T infusion after lymphodepletion. The lymphodepleting chemotherapy is administered on days -5, -4, and -3 before CAR T infusion using cyclophosphamide 300mg/m2 once daily and fludarabine 30mg/m2 once daily for 3 consecutive days. Doses may be adjusted for renal and/or hepatic insufficiency, or other comorbidities. The study is designed to include the following sequential steps: patient screening, pre-treatment, treatment and follow up for up to 2 years.