Clinical trial · Interventional
Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL
A Prospective Study of Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy on the Efficacy and Safety of Patients With Relapsed and Refractory Aggressive B-cell Non-Hodgkin Lymphoma.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T | Other | — | UNRESOLVED |
| integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 (PET/CT-, ctDNA+)
- description
- Patients will receive low-dose radiotherapy (RT) combined with reduced-intensity SEAM/TB chemotherapy as a conditioning regimen, followed by autologous stem cell transplantation (ASCT) and sequential CAR-T cell therapy.
- interventionNames
- Other: integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T
- type
- EXPERIMENTAL
- label
- Cohort 2 (PET/CT+, ctDNA+)
- description
- Patients will receive high-dose RT combined with reduced-intensity SEAM/TB chemotherapy as a conditioning regimen, followed by ASCT and sequential CAR-T cell therapy.
- interventionNames
- Other: integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available