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OncoMatch/Clinical Trials/NCT07093086

Clinical Study of Multi-targeted CAR-T Therapy in Patients With Relapsed/Refractory B-Cell Lymphoma

Is NCT07093086 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Triple-targeted CAR-T Therapy for b-cell lymphoma.

Phase 1RecruitingShanghai Unicar-Therapy Bio-medicine Technology Co.,LtdNCT07093086Data as of May 2026

Treatment: Triple-targeted CAR-T TherapyThis is a single-arm, open-label clinical study evaluating the efficacy and safety of CD20/CD19/CD22 multi-targeted chimeric antigen receptor T-cell (CAR-T) injection in patients with relapsed/refractory B-cell lymphoma.

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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: CD20 positive by immunohistochemistry

Tumor tissue (archival or fresh biopsy) positive for CD20 and/or CD19 and/or CD22 by immunohistochemistry

Required: CD19 positive by immunohistochemistry

Tumor tissue (archival or fresh biopsy) positive for CD20 and/or CD19 and/or CD22 by immunohistochemistry

Required: CD22 positive by immunohistochemistry

Tumor tissue (archival or fresh biopsy) positive for CD20 and/or CD19 and/or CD22 by immunohistochemistry

Performance status

ECOG 0–3(Limited self-care)

Prior therapy

Min 2 prior lines

Must have received: anti-cd20 monoclonal antibody

Must have received: anthracycline-containing regimen

Lab requirements

Blood counts

Absolute lymphocyte count (ALC) ≥0.3 × 10⁹/L; Platelets ≥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 attributable to tumor infiltration); ALT ≤3×ULN (≤5×ULN if attributable to tumor infiltration); Total bilirubin ≤2×ULN (≤3×ULN with direct bilirubin ≤1.5×ULN for Gilbert's syndrome)

Cardiac function

LVEF ≥50 % by echocardiography; QTc interval ≤480 ms (Fridericia correction)

Adequate marrow reserve at screening: Absolute lymphocyte count (ALC) ≥0.3 × 10⁹/L; Platelets ≥30 × 10⁹/L (transfusion permitted). Adequate organ function: AST ≤3×ULN (≤5×ULN if attributable to tumor infiltration); ALT ≤3×ULN (≤5×ULN if attributable to tumor infiltration); 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 reserve: ≤Grade 1 dyspnea and SpO₂ >91 % on room air; LVEF ≥50 % by echocardiography; INR ≤1.5×ULN and APTT ≤1.5×ULN. QTc interval >480 ms (Fridericia correction), or left-ventricular ejection fraction <50 % by echocardiography at screening [excluded].

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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