OncoMatch/Clinical Trials/NCT05438667
TCR-T Cell Therapy on Advanced Solid Tumors
Is NCT05438667 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT05438667 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received platinum-based chemotherapy and immunotherapy.
Does this trial require KRAS?
Yes, KRAS g12d is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS g12v is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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