RecruitingRecruiting
Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL
NCT07059741 · The First Affiliated Hospital of Soochow University
In plain English
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Official title
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.
About this study
This trial will enroll R/R aggressive B-NHL patients aged ≥18 years who have undergone at least two prior lines of systemic therapy. Participants will be stratified into two cohorts based on post-salvage therapy disease status:
Cohort 1 (PET/CT-, ctDNA+): Patients will receive low-dose radiotherapy (RT) combined with reduced-intensity SEAM/TB chemotherapy as a conditioning regimen, followed by ASCT and sequential CAR-T therapy.
Cohort 2 (PET/CT+, ctDNA+): Patients will receive high-dose RT combined with reduced-intensity SEAM/TB chemotherapy as a conditioning regimen, followed by ASCT and sequential CAR-T therapy.
All patients completing the combined ASCT-CAR-T protocol will undergo longitudinal follow-up for safety, efficacy survival outcomes .
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.
Study design
Enrollment target: 20 participants
Allocation: non_randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-12-10
Estimated completion: 2028-12-10
Last updated: 2025-07-11
Interventions
Other: integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-TOther: integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T
Primary outcomes
- • Complete remission rate(CRR) (At the end of 3 months after CAR-T infusion)
Sponsor
The First Affiliated Hospital of Soochow University · other
Contacts & investigators
ContactChangju Qu · contact · qcj310@163.com · 67781856
All locations (1)
the First Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, Jiangsu, China