OncoMatch/Clinical Trials/NCT05631886
Combination of CAR-DC Vaccine and ICIs in Malignant Tumors
Is NCT05631886 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for solid tumor, adult.
Treatment: TP53-EphA-2-CAR-DC · Abraxane · Cyclophosphamide · anti-PD-1 antibody · Anti-CTLA4 Monoclonal Antibody — This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with TP53 mutant peptide (TP53-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of TP53-EphA-2-CAR-DC vaccine; detect T cell response against TP53 mutant peptide and tumor neoepitopes after the treatment with TP53-EphA-2-CAR-DC vaccine and ICIs.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Non-Hodgkin Lymphoma
Biomarker criteria
Required: EPHA2 overexpression (≥20%)
Required: TP53 r175h
Required: TP53 r248q
Required: TP53 r249s
Required: TP53 r273h
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — lymphoma
Relapse after treatment with ≥2 lines systemic therapy or refractory disease for lymphomas
Cannot have received: (TP53 mutant (R273H or R175H or R248Q or R249S) targeted therapy, EphA2 targeted therapy)
Previous treatment involving TP53 mutant (R273H or R175H or R248Q or R249S) and EphA2
Lab requirements
Blood counts
ANC ≥1000 cells/μL; Platelet count ≥80,000/μL; Hemoglobin ≥8.0 g/dL (hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions)
Kidney function
Serum creatinine ≤2 x ULN or creatinine clearance of ≥45 mL/min
Liver function
Serum AST and serum ALT ≤3.0 x ULN (≤5 x ULN for patients with liver metastases); Total serum bilirubin ≤3.0 x ULN
Adequate organ function as defined by the following criteria: ANC ≥1000 cells/μL; Platelet count ≥80,000/μL; Hemoglobin ≥8.0 g/dL (hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions); Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver metastases); Total serum bilirubin ≤3.0 x ULN); Serum creatinine ≤2 x ULN or creatinine clearance of ≥45 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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