Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jul 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a type of aggressive blood cancer called relapsed or refractory B-cell Non-Hodgkin lymphoma (B-NHL), which means the cancer has either returned or hasn’t responded well to previous treatments. The study combines three treatments: radiotherapy (a type of targeted radiation), followed by a stem cell transplant using the patient’s own cells, and then a special immune therapy called CAR-T cell therapy. The goal is to see if this combination is safe and more effective in helping patients get better.

Adults aged 18 and older with confirmed aggressive B-NHL who are healthy enough for treatment and have a reasonable life expectancy may be eligible to join. Participants will need to have good heart, liver, kidney, lung, and bone marrow function and be willing to provide consent and follow birth control guidelines if applicable. During the trial, patients will receive the integrated treatments in sequence, and doctors will closely monitor their response and any side effects. This study is currently recruiting, and by exploring this new combination, researchers hope to improve outcomes for patients facing this challenging cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years.
• • 2. Histologically confirmed aggressive B-NHL.
• • 3. Life expectancy \>3 months.
• 4. Appropriate organ function:
• • Cardiac function: cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and glutamic aminotransferase ≤ 2 times the upper limit of normal values; renal function: serum creatinine clearance ≥80 mL/min; serum creatinine \<160 mmol/L Lung function: SPO2\>91% without oxygen intake
• 5. Adequate bone marrow reserve defined as:
• • hemoglobin ≥90 g/L. platelet count ≥70 x 10\^9/L. absolute neutrophil count ≥1.5 x 10\^9/L.
• • 6. The patient is capable of understanding and willing to provide written informed consent.
• • 7. Subjects of childbearing or childbearing potential must be willing to practice birth control from the date of enrollment in this study until study follow-up.
• Exclusion Criteria:
• • 1. severe hepatic and renal function abnormalities (alanine aminotransferase, bilirubin, creatinine \> 2 times the upper limit of normal);
• • 2. Presence of organic heart disease with resulting clinical symptoms or abnormal cardiac function (NYHA cardiac function classification ≥ grade 2);
• • 3. ECG QTc interval \>500 ms;
• • 4. active hepatitis B/hepatitis C;
• • 5. uncontrolled active infection;
• • 6. human immunodeficiency virus infection;
• • 7. concurrent other tumors requiring treatment or intervention;
• • 8. current or anticipated need for systemic corticosteroid therapy;
• • 9. pregnant or lactating women;
• • 10. abandonment of consolidation autologous hematopoietic stem cell transplantation for financial reasons;
• • 11. other psychological conditions that prevent the patient from participating in the study or signing the informed consent form;
• • 12. Subjects who, in the judgment of the investigator, are unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or do not meet the requirements for participation in the study.