OncoMatch/Clinical Trials/NCT07456371
PIC1 Injection Therapy for Relapsed/Refractory B-NHL
Is NCT07456371 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PIC1 for non-hodgkin lymphoma.
Treatment: PIC1 — This is an investigator-initiated trial aimed at assessing the safety and efficacy of PIC1 injection in the treatment of relapsed/refractory B-cell Non-Hodgkin Lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positivity (positive by IHC or flow cytometry)
CD19 positivity confirmed by immunohistochemistry (IHC) or flow cytometry
Allowed: MYC rearrangement
HGBL with MYC and BCL2 and/or BCL6 rearrangements
Allowed: BCL2 rearrangement
HGBL with MYC and BCL2 and/or BCL6 rearrangements
Allowed: BCL6 rearrangement
HGBL with MYC and BCL2 and/or BCL6 rearrangements
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-CD20 monoclonal antibody
Patients must have received adequate prior therapy including an anti-CD20 monoclonal antibody and an anthracycline, unless contraindicated or intolerant (i.e., CD20-negative status, intolerance to anti-CD20 mAb, or contraindication to anthracyclines)
Must have received: anthracycline
Patients must have received adequate prior therapy including an anti-CD20 monoclonal antibody and an anthracycline, unless contraindicated or intolerant (i.e., CD20-negative status, intolerance to anti-CD20 mAb, or contraindication to anthracyclines)
Cannot have received: CAR-T cell therapy
Received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy or any other gene-modified cell therapy before screening
Cannot have received: gene-modified cell therapy
Received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy or any other gene-modified cell therapy before screening
Lab requirements
Blood counts
Neutrophil Count ≥ 1.0 × 10^9/L; Platelet count ≥ 75 × 10^9/L; Hemoglobin ≥ 80 g/L. (For subjects with bone marrow involvement: Neutrophil ≥ 0.5 × 10^9/L and Platelet count ≥ 50 × 10^9/L.)
Kidney function
Serum creatinine ≤2.0 × ULN or Creatinine Clearance ≥50 mL/min (Cockcroft-Gault)
Liver function
ALT and AST ≤3.0 × ULN (or ≤5.0 × ULN for subjects with hepatic involvement); Total bilirubin ≤2.0 × ULN (or ≤3.0 × ULN for subjects with Gilbert's syndrome)
Cardiac function
Left Ventricular Ejection Fraction (LVEF) ≥40% by echocardiogram
Adequate major organ function defined as: Cardiac function: LVEF ≥40% by echocardiogram. Renal function: Serum creatinine ≤2.0 × ULN or Creatinine Clearance ≥50 mL/min (Cockcroft-Gault). Hepatic enzymes: ALT and AST ≤3.0 × ULN (or ≤5.0 × ULN for subjects with hepatic involvement). Bilirubin: Total bilirubin ≤2.0 × ULN (or ≤3.0 × ULN for subjects with Gilbert's syndrome). Hematology: Neutrophil Count ≥ 1.0 × 10^9/L; Platelet count ≥ 75 × 10^9/L; Hemoglobin ≥ 80 g/L. (For subjects with bone marrow involvement: Neutrophil ≥ 0.5 × 10^9/L and Platelet count ≥ 50 × 10^9/L.)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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