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

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About this study

This study aims to investigate a novel therapeutic strategy of integrated radiotherapy before autologous stem cell transplantation (ASCT) sequential chimeric antigen receptor T-cell(CAR-T) therapy for patients with relapsed/refractory(R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL). By evaluating the efficacy and safety of this multimodal approach, we seek to provide a theoretical foundation and clinical data to optimize outcomes for relapsed/refractory aggressive B-NHL patients.

Condition
Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)
Tested
integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T, integrated high-dose RT with redu...
Sponsor
The First Affiliated Hospital of Soochow University

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 11

  • Minimum age: 18 years
  • Study condition: Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)
  • Age ≥18 years.
  • Histologically confirmed aggressive B-NHL.
  • Life expectancy \>3 months.
  • 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
  • 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.
  • The patient is capable of understanding and willing to provide written informed consent.
  • 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 12

  • severe hepatic and renal function abnormalities (alanine aminotransferase, bilirubin, creatinine \> 2 times the upper limit of normal);
  • Presence of organic heart disease with resulting clinical symptoms or abnormal cardiac function (NYHA cardiac function classification ≥ grade 2);
  • ECG QTc interval \>500 ms;
  • active hepatitis B/hepatitis C;
  • uncontrolled active infection;
  • human immunodeficiency virus infection;
  • concurrent other tumors requiring treatment or intervention;
  • current or anticipated need for systemic corticosteroid therapy;
  • pregnant or lactating women;
  • abandonment of consolidation autologous hematopoietic stem cell transplantation for financial reasons;
  • other psychological conditions that prevent the patient from participating in the study or signing the informed consent form;
  • 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

1 site, 1 recruiting

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.