OncoMatch/Clinical Trials/NCT07093073
Clinical Study of U01（ssCART-19） in Patients With B-Cell Lymphoma
Is NCT07093073 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07093073 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received anti-CD20 monoclonal antibody and anthracycline-containing regimen.
Does this trial require CD19?
Yes, CD19 positive by IHC is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger and at least 2 years old.
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