OncoMatch/Clinical Trials/NCT07093073
Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma
Is NCT07093073 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies ssCART-19 for b cell lymphoma.
Treatment: ssCART-19 — This is a single-arm, open-label clinical study evaluating the efficacy and safety of U01 (ssCART-19) in patients with relapsed or refractory B-cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive by IHC
Tumor tissue (archival or fresh) positive for CD19 by IHC; pathology report within 6 months preferred.
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: anti-CD20 monoclonal antibody
Prior regimens must have included anti-CD20 monoclonal antibody (unless documented CD20-negative tumor)
Must have received: anthracycline-containing regimen
Prior regimens must have included...an anthracycline-containing regimen
Lab requirements
Blood counts
ALC ≥0.3 × 10⁹/L; PLT ≥30 × 10⁹/L (transfusion permitted)
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault)
Liver function
AST ≤3×ULN (≤5×ULN if tumor-related); ALT ≤3×ULN (≤5×ULN if tumor-related); Total bilirubin ≤2×ULN (≤3×ULN with direct bilirubin ≤1.5×ULN for Gilbert's syndrome)
Cardiac function
LVEF ≥50 % by echocardiography; QTc ≤480 ms (Fridericia correction)
Adequate marrow reserve: ALC ≥0.3 × 10⁹/L; PLT ≥30 × 10⁹/L (transfusion permitted). Adequate organ function: AST ≤3×ULN (≤5×ULN if tumor-related); ALT ≤3×ULN (≤5×ULN if tumor-related); Total bilirubin ≤2×ULN (≤3×ULN with direct bilirubin ≤1.5×ULN for Gilbert's syndrome); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault); Pulmonary: ≤Grade 1 dyspnea and SpO₂ >91 % on room air; LVEF ≥50 % by echocardiography; INR ≤1.5×ULN and APTT ≤1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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