OncoMatch/Clinical Trials/NCT06446128
A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)
Is NCT06446128 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CD19/CD20/BCMA CAR T cells for non-hodgkin lymphoma, b-cell.
Treatment: CD19/CD20/BCMA CAR T cells — This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 overexpression (positive (including weak, medium and strong positive))
Immunohistochemical staining shows at least two of B cell surface receptor antigen CD19,CD20, BCMA are positive(including weak, medium and strong positive)
Required: CD20 overexpression (positive (including weak, medium and strong positive))
Immunohistochemical staining shows at least two of B cell surface receptor antigen CD19,CD20, BCMA are positive(including weak, medium and strong positive)
Required: BCMA (TNFRSF17) overexpression (positive (including weak, medium and strong positive))
Immunohistochemical staining shows at least two of B cell surface receptor antigen CD19,CD20, BCMA are positive(including weak, medium and strong positive)
Allowed: MYC rearrangement
High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) /BCL6 (B-cell lymphoma6) rearrangement
Allowed: BCL2 rearrangement
High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) /BCL6 (B-cell lymphoma6) rearrangement
Allowed: BCL6 rearrangement
High grade B-cell lymphoma (HGBCL) with MYC(myelocytomatosis oncogene) and BCL2(B-cell lymphoma2) /BCL6 (B-cell lymphoma6) rearrangement
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-CD20 monoclonal antibody
anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative
Must have received: anthracycline containing chemotherapy regimen
an anthracycline containing chemotherapy regimen
Cannot have received: anti-CD45 therapy
Individuals who have antiCD45 or antiCD3 therapy
Cannot have received: anti-CD3 therapy
Individuals who have antiCD45 or antiCD3 therapy
Cannot have received: allogeneic stem cell transplantation
History of allogeneic stem cell transplantation
Lab requirements
Blood counts
ANC ≥1 ×10^9/L; ALC ≥ 0.5 ×10^9/L; Platelets ≥50 ×10^9/L; Hemoglobulin ≥80 g/L (≥60 g/L if bone marrow involvement)
Kidney function
Serum creatinine ≤ 1.5 ULN, or eGFR ≥ 60 mL/min/1.73m2
Liver function
ALT/AST ≤ 5 ULN; total bilirubin ≤ 2 ULN (≤ 3 ULN and direct bilirubin ≤ 1.5 ULN for Gilbert syndrome); INR or PT ≤ 1.5 ULN
Cardiac function
LVEF ≥50% by echocardiogram or MUGA
Adequate renal, hepatic, pulmonary and cardiac function defined as: Renal function: Serum creatinine ≤ 1.5 upper limit of normal(ULN), or eGFR ≥ 60 mL/min/1.73m2 ... Hepatic function: i: Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 5 ULN and ii: total bilirubin ≤ 2 ULN, except in individuals with Gilbert syndrome (in Gilbert's syndrome patients, those with total bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN can be enrolled).iii: International normalized ratio (INR) or prothrombin time (PT) ≤1.5 ULN Pulmonary: Have the minimum level of pulmonary reserve, defined as ≤ CTCAE (Common Terminology Criteria for Adverse Events) grade 1 dyspnea and the SaO2(oxygen saturation)≥ 91% on room air Cardiac: left ventricular ejection fraction (LVEF) ≥50% determined by echocardiogram(ECG) or multigated acquisition scan (MUGA)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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