OncoMatch/Clinical Trials/NCT07097207
Efficacy and Safety of CD19CD20-CAR.p40-T in B-cell Lymphoma
Is NCT07097207 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT07097207 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antibody-based drug, CAR-T cell product or other genetically modified T cell therapies disqualifies patients from enrollment.
Does this trial require MS4A1?
Yes, MS4A1 expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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