OncoMatch/Clinical Trials/NCT04836507
Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients
Is NCT04836507 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including CRC01 and Fludarabine for relapsed large b-cell lymphoma.
Treatment: CRC01 · Fludarabine · Cyclophosphamide — This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: rituximab
Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT.
Must have received: anthracycline
Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT.
Cannot have received: anti-CD19/anti-CD3 therapy
Prior treatment with any prior anti-CD19/anti-CD3 therapy or any other anti-CD19 therapy
Cannot have received: adoptive T cell therapy
Prior treatment with any adoptive T cell therapy
Cannot have received: gene therapy product
Treatment with any prior gene therapy product
Cannot have received: allogeneic HSCT
Prior allogeneic HSCT
Lab requirements
Blood counts
Hemoglobin > 8.0g/dL; ANC > 1,000/μL; ALC ≥ 300/μL; Platelets ≥ 50,000/μL (without transfusions within 2 weeks prior to screening)
Kidney function
Serum creatinine ≤ 1.5 X ULN; eGFR ≥ 60mL/min/1.73m2
Liver function
Total Bilirubin ≤ 2.0mg/dL (Gilbert-Meulengracht syndrome: ≤ 3 X ULN and direct bilirubin ≤ 1.5 X ULN); AST and ALT ≤ 3 X ULN (≤ 5 X ULN with liver metastasis)
Cardiac function
Hemodynamically stable, without pericardial effusion and LVEF ≥ 50% confirmed by Echocardiogram (ECG) or MUGA
Adequate renal and hepatic functions based on the laboratory test results; Adequate hematologic function without transfusions within 2 weeks prior to screening; Hemodynamically stable, without pericardial effusion and LVEF ≥ 50% confirmed by Echocardiogram (ECG) or Multigated Radionuclide Angiography (MUGA)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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