OncoMatch/Clinical Trials/NCT06987916
Efficacy and Safety Evaluation of U01(ssCART-19) in B-Cell Lymphoma
Is NCT06987916 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06987916 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received CD20 monoclonal antibody and anthracycline-based regimen.
Does this trial require CD19?
Yes, CD19 positivity confirmed by immunohistochemistry (IHC) of tumor tissue (preferably within 6 months) 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