OncoMatch/Clinical Trials/NCT06830031
Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma
Is NCT06830031 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies C402-CD19-CAR for diffuse large b-cell-lymphoma.
Treatment: C402-CD19-CAR — This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: CD19 overexpression (IHC ≥ 50% or flow cytometry ≥ 70%)
CD19-positive lymphoma levels ≥ 50% by IHC or CD19-positive lymphoma levels ≥ 70% by flow cytometry
Allowed: MYC rearrangement
high-grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangements
Allowed: BCL2 rearrangement
high-grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangements
Allowed: BCL6 rearrangement
high-grade B-cell lymphoma (HGBL) with MYC, BCL2, and/or BCL6 rearrangements
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline-based therapy
must have received at least anthracycline-based therapy
Must have received: CD20-targeted therapy (rituximab)
must have received at least ... rituximab (or other CD20-targeted drugs, excluding CD20-negative cases)
Cannot have received: allogeneic hematopoietic stem cell transplantation
History of receiving allogeneic hematopoietic stem cell transplantation
Cannot have received: adoptive cell therapy
adoptive cell therapy (such as CAR-T therapy), or other gene-modified cell therapies
Cannot have received: anti-tumor treatment
Subjects who have received anti-tumor treatment within 8 weeks or 5 half-lives (specific medications need to be assessed in detail) before PBMC collection, including chemotherapy, CD20-targeted therapy, etc.; local radiotherapy within 12 weeks
Cannot have received: fludarabine (fludarabine)
received fludarabine ... within 3 months before PBMC collection
Cannot have received: cladribine (cladribine)
received ... cladribine ... within 3 months before PBMC collection
Cannot have received: bendamustine (bendamustine)
received ... bendamustine treatment within 3 months before PBMC collection
Cannot have received: alendronate (alendronate)
received alendronate treatment within 6 months before PBMC collection
Lab requirements
Blood counts
Hemoglobin ≥ 80 g/L, absolute neutrophil count ≥ 1.0 × 10^9/L, platelet count ≥ 75 × 10^9/L, lymphocyte count ≥ 0.5 × 10^9/L
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN (for patients with Gilbert's syndrome or lymphoma involving the liver, ≤ 3 × ULN); ALT and AST ≤ 3 × ULN
Cardiac function
Ejection fraction ≥ 50%, with no clinically significant pericardial effusion or pleural effusion detected
Liver and kidney function, as well as heart and lung function, should meet the following requirements: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (using the Cockcroft-Gault formula); Ejection fraction ≥ 50%, with no clinically significant pericardial effusion or pleural effusion detected; Oxygen saturation ≥ 92% without oxygen support; Total bilirubin ≤ 1.5 × ULN (for patients with Gilbert's syndrome or lymphoma involving the liver, ≤ 3 × ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; Fibrinogen ≥ 1.0 g/L; activated partial thromboplastin time ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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