Radiation‑optimized autologous stem cell transplant followed by sequential CAR‑T for relapsed/refractory aggressive B‑cell NHL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional protocol enrolls adults with relapsed/refractory aggressive B‑cell non‑Hodgkin lymphoma who have had at least two prior systemic therapies. Participants are stratified by post‑salvage status into two cohorts based on PET/CT and circulating tumor DNA: one cohort receives low‑dose radiotherapy plus reduced‑intensity SEAM/TB conditioning before ASCT and CAR‑T, and the other receives high‑dose radiotherapy with the same reduced conditioning before ASCT and CAR‑T. All subjects proceed to autologous stem cell transplantation followed by sequential CAR‑T infusion and are followed longitudinally for safety, response, and survival outcomes. The design tests whether tailoring radiation dose by imaging and ctDNA can improve tolerability and longer‑term control when combined with ASCT and CAR‑T.

Why it matters

Who can join: the full rules

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.

Where it's running

• the First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Changju Qu
• Email: qcj310@163.com
• Phone: 67781856

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.