OncoMatch/Clinical Trials/NCT06987916
Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma
Is NCT06987916 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ssCART-19 for b cell lymphoma.
Treatment: ssCART-19 — This is an open-label phase1 study to assess the safety and efficacy of U01(ssCART-19) cell therapy in the treatment of patients with refractory or recurrent B-cell lymphoma .
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months)
CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months)
Allowed: CD20 negativity (if CD20-negative tumor confirmed by the investigator)
Prior treatments must include CD20 monoclonal antibody (unless CD20-negative tumor confirmed by the investigator)
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: CD20 monoclonal antibody
Prior treatments must include CD20 monoclonal antibody (unless CD20-negative tumor confirmed by the investigator)
Must have received: anthracycline-based regimen
Prior treatments must include...anthracycline-based regimens
Must have received: standard chemotherapy regimen — first-line
Failure to achieve partial response (PR) after first-line therapy, or relapse within 12 months post-first-line therapy
Must have received: salvage regimen — second-line
Relapsed/refractory B-cell lymphoma after second-line therapy (one standard chemotherapy regimen + one salvage regimen)
Lab requirements
Blood counts
Absolute lymphocyte count (ALC) ≥0.3×10⁹/L; Platelet count (PLT) ≥30×10⁹/L
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)
Liver function
AST/ALT ≤3×ULN (≤5×ULN if due to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN for Gilbert syndrome with direct bilirubin ≤1.5×ULN)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%; QTe interval <480 ms (Fridericia correction)
Adequate bone marrow reserve at screening: Absolute lymphocyte count (ALC) ≥0.3×10⁹/L; Platelet count (PLT) ≥30×10⁹/L. Adequate organ function: AST/ALT ≤3×ULN (≤5×ULN if due to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN for Gilbert syndrome with direct bilirubin ≤1.5×ULN); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); Oxygen saturation >91% on room air (dyspnea grade ≤1); Left ventricular ejection fraction (LVEF) ≥50%; 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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