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

Trial details

Who runs it

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

Trial code

NCT07093086

Record updated

2026. május 6.

Original description

This 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.Read full original descriptionShow less

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.

This 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.

Inclusion: Voluntary written informed consent obtained from the participant (or legally authorized representative) with good compliance expected throughout the study; All of the following must be fulfilled:; Age 2-75 years at the time of informed consent; both sexes eligible.For minors (≤18 years), consent must be provided by a parent or legal guardian; minors who are able to sign must co-sign with their guardian; Histologically confirmed B-cell lymphoma according to the NCCN Clinical Practice Guidelines in Oncology: B-Cell Lymphomas (2024 v3); Relapsed or refractory B-cell lymphoma after at least two prior lines of therapy (one standard chemo-regimen + one salvage regimen) that must have included:; anti-CD20 monoclonal antibody (except for subjects with documented CD20-negative tumors), and; an anthracycline-containing regimen; Subjects must additionally meet at least one of the following:; Ineligible for autologous hematopoietic stem-cell transplantation (ASCT); ii. Refusal of ASCT; iii. Relapse after ASCT. d) Disease status at screening:; Relapse: progression after prior response (PR or CR); Refractory: i. No response to last therapy (progressive disease [PD] during/after, or best response ≤SD lasting <6 months); OR ii. Relapse or progression after ASCT (biopsy-proven) including: relapse/PD ≤12 months post-ASCT, or relapse/PD after salvage therapy post-ASCT without response (SD or PD); Tumor tissue (archival or fresh biopsy) positive for CD20 and/or CD19 and/or CD22 by immunohistochemistry (pathology report within 6 months preferred); ≥1 measurable lesion per Lugano 2014 (Cheson) criteria; ECOG performance status 0-3; 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; Women of child-bearing potential must have a negative serum/urine pregnancy test within 7 days before CAR-T infusion. All participants with reproductive potential must use effective contraception from screening through at least 12 months after the last CAR-T dose; Adequate venous access for leukapheresis or repeated phlebotomy, with no contraindications to leukapheresis; Anticipated survival ≥3 months.

Exclusion: Concurrent malignancy other than the study indication. Exceptions: carcinoma in situ or any malignancy with disease-free survival ≥3 years; Use of immunosuppressive agents or systemic corticosteroids within 1 week before leukapheresis that, in the investigator's judgment, could substantially impair T-cell function; Prior or current CNS disorders unrelated to lymphoma-e.g., seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any CNS autoimmune disease-deemed uncontrolled by the investigator; Receipt of any live vaccine within 6 weeks before screening; Participation in any other interventional clinical trial within 30 days before signing informed consent; Presence of any of the following:• Positive HBe-Ab and/or HBc-Ab with HBV-DNA above the lower limit of quantification;• Positive HCV-Ab with HCV-RNA above the lower limit of quantification;• Positive Treponema pallidum antibody (TP-Ab);• Positive HIV antibody; Active bacterial, fungal, viral, mycoplasmal, or other infection that, in the investigator's opinion, cannot be adequately controlled; History of severe immediate hypersensitivity to any study-related drug; Active autoimmune disease requiring systemic immunosuppressive therapy; Any condition that, in the investigator's opinion, renders the subject unsuitable for study participation; Within 12 months before informed consent: percutaneous coronary intervention (angioplasty or stent placement), or NYHA Class III-IV congestive heart failure, or history of myocardial infarction, unstable angina, or other clinically significant cardiac disease judged by the investigator. QTc interval >480 ms (Fridericia correction), or left-ventricular ejection fraction <50 % by echocardiography at screening; Known primary immunodeficiency; Pregnant or breastfeeding women.

ClinicalTrials.gov NCT07093086