OncoMatch/Clinical Trials/NCT07456371
PIC1 Injection Therapy for Relapsed/Refractory B-NHL
Is NCT07456371 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07456371 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, gene-modified cell therapy disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 positivity 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.
Check if I qualifyRelated pages