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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06830031 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplantation, adoptive cell therapy, anti-tumor treatment disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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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