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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.

Early Phase 1RecruitingBioSyngen Pte LtdNCT06152757Data as of May 2026

Treatment: First dose · Second dose · The third dose · The fourth doseThis 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.

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Extracted 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

Min 1 prior line

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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