OncoMatch/Clinical Trials/NCT05438667
TCR-T Cell Therapy on Advanced Solid Tumors
Is NCT05438667 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies TCR-T therapy for pancreatic cancer.
Treatment: TCR-T therapy — The primary aim of this study is to evaluate the efficacy of KRAS mutant antigen specific TCR-T cells in the treatment of patients with advanced solid tumors. The secondary aim is to evaluate the pharmacokinetic/pharmacodynamic characteristics of TCR-T cell therapy in patients with advanced solid tumors and the survival of TCR-T cells. The investigators will evaluate the changes of tumor microenvironment after treatment of advanced solid tumors with KRAS mutant antigen specific TCR-T cells; Evaluating the correlation between cytokines and the occurrence of CRS and neurotoxicity
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: KRAS g12d
Required: KRAS g12v
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy — Non-Small Cell Lung Cancer
previously treated with platinum-based chemotherapy
Must have received: immunotherapy — Non-Small Cell Lung Cancer
previously treated with ... immunotherapy
Must have received: anti-angiogenic therapy — Non-Small Cell Lung Cancer
previously treated with ... anti-angiogenic therapy
Must have received: systemic therapy — Pancreatic Ductal Adenocarcinoma
failed at least one prior systemic therapy
Must have received: systemic therapy (oxaliplatin, irinotecan, fluoropyrimidine-based agents, anti-angiogenic drugs) — Colorectal Carcinoma
failed at least two prior systemic therapies (including oxaliplatin, irinotecan, fluoropyrimidine-based agents, anti-angiogenic drugs, etc.)
Lab requirements
Blood counts
ANC ≥ 1.5×10⁹/L, ALC ≥ 0.5×10⁹/L, Platelet count ≥ 50×10⁹/L, Hemoglobin ≥ 90g/L
Kidney function
Serum creatinine ≤ 1.5x ULN or creatinine clearance ≥ 60 mL/min
Liver function
Bilirubin < 1.5x ULN (Bile duct obstruction due to tumor compression excluded); ALT/AST < 2.5x ULN (≤5x ULN with liver metastasis)
Organ function and bone marrow reserve are in good condition, and the following requirements must be met: 1)Absolute neutrophil count≥1.5×10⁹/L, Absolute lymphocyte count ≥0.5×10⁹/L；2)Platelet count≥50×10⁹/L；3)Hemoglobin≥90g/L；4)Bilirubin < 1.5 times upper limit of normal（Bile duct obstruction due to tumor compression were excluded)；5)Serum creatinine ≤ 1.5 times the upper limit of normal range or creatinine clearance ≥ 60 mL/min.6)Serum alanine aminotransferase or aspartate aminotransferase is < 2.5 times the upper limit of the normal value (ULN) (if patients with liver metastasis, ≤5 times the ULN).7)Coagulation function normalised：INR≤1.5，PTT<1.2 times the upper limit of normal（Tumor - related anticoagulant therapy was excluded).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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