OncoMatch/Clinical Trials/NCT07097207
Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma
Is NCT07097207 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies CAR-T cell for relapsed/refractory b-cell lymphoma.
Treatment: CAR-T cell — 1. Study Title: A Study on the Efficacy and Safety of Autocrine p40 CD19/CD20 Dual-Targeting Chimeric Antigen Receptor T-Cells (CD19/CD20-CAR.p40-T) in Relapsed/Refractory B-Cell Lymphoma 2. Study Objectives: * Primary Objective: To evaluate the safety of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. * Secondary Objective: To evaluate the efficacy of CD19/CD20 dual-targeting CAR.p40-T cell therapy in patients with relapsed/refractory B-cell lymphoma. 3. Participant Intervention: * Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned CD19/CD20-CAR.p40-T cell infusion or CD19 CAR.p40-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: MS4A1 expression (confirmed by flow cytometry/immunohistochemistry)
Confirmation of CD20 expression in tumor cells by flow cytometry/immunohistochemistry
Allowed: CD19 low expression
Patients tolerant to CD19 CAR-T cell therapy or those with low CD19 expression
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard first- and second-line treatment regimens
The subject must have received standard first- and second-line treatment regimens
Cannot have received: antibody-based drug
Exception: within 2 weeks before cell therapy
Not having received antibody-based drug treatment within 2 weeks before cell therapy
Cannot have received: CAR-T cell product or other genetically modified T cell therapies
Previous use of any CAR-T cell product or other genetically modified T cell therapies
Lab requirements
Blood counts
WBC > 1×10⁹/L, ANC > 0.5×10⁹/L, ALC > 0.5×10⁹/L, PLT > 25×10⁹/L
Kidney function
serum creatinine < 2.0 mg/dl
Liver function
total serum bilirubin < 1.5 mg/dl; ALT/AST ≤ 2.5x ULN
Cardiac function
No severe heart diseases; NYHA class < III; LVEF ≥ 50%; no recent MI/angioplasty/stenting/unstable angina within 12 months; no grade 3 hypertension with poorly controlled BP
No severe heart, lung, liver, or kidney diseases; The following conditions in the blood routine examination: White blood cell count (WBC) ≤ 1×10⁹/L, absolute neutrophil count (ANC) ≤ 0.5×10⁹/L, absolute lymphocyte count (ALC) ≤ 0.5×10⁹/L, platelet count (PLT) ≤ 25×10⁹/L; The following conditions in laboratory tests: including but not limited to, total serum bilirubin ≥ 1.5 mg/dl; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the upper limit of normal; serum creatinine ≥ 2.0 mg/dl; Patients with heart failure classified as grade III or IV according to the New York Heart Association (NYHA) classification criteria; or left ventricular ejection fraction (LVEF) < 50% as detected by echocardiography; Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically severe heart diseases within 12 months before enrollment; Grade 3 hypertension with poorly controlled blood pressure despite drug treatment; Abnormal lung function with oxygen saturation < 92% under room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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