OncoMatch/Clinical Trials/NCT06152757
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
Is NCT06152757 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including First dose and Second dose for gastrointestinal tumors.
Treatment: First dose · Second dose · The third dose · The fourth dose — This study is an exploratory single-arm, open, modified "3+3" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent/refractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection. Four dose levels were designed for this study: 1.0×10\^8cells, 3.0×10\^8cells, 1.0×10\^9cells, and 3.0×10\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent/refractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Esophageal Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: second-line or above treatment
failed the standard of second-line or above treatment or are not suitable for/refuse to accept the standard treatment or cannot tolerate the standard treatment
Cannot have received: systemic chemotherapy
Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis
Cannot have received: immunotherapy
Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis
Cannot have received: small molecule targeted therapy
Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis
Cannot have received: CAR-T cell therapy
received chimeric antigen receptor modified T cells (including CAR-T, CTT-T) treatment within half a year
Lab requirements
Blood counts
adequate organ and bone marrow function
Kidney function
adequate organ and bone marrow function
Liver function
adequate organ and bone marrow function
adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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