Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)NCT07059741
Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL
A study testing integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T and integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T in people with Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)
- What is being tested?
- integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T and integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 10 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Changju Qu, 67781856, qcj310@163.com
About this study
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.
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.
Read the detailed description
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 .
- Being tested
- integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T, integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T
- Keywords
- Radiotherapy, autologous stem cell transplantation, Relapsed and refractory, circulating tumor DNA, Chimeric antigen receptor T-cell therapy
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-TOther
- RT regimen: localized low dose RT: 1-1.5Gy/fraction*5fractions
- Reduced dose SEAM regimen (CNS uninvolved):
- Simustine 250mg/m2 d-6 orally
- Cytarabine 200mg/m2 q12h d-5~d-4 intravenous infusion
- Etoposide 100mg/m2 q12h d-5~d-4 intravenous infusion
- Melphalan 140mg/m2 q12h d-3 intravenous infusion
- TB regimen (CNS involvement):
- Thiotepa 250mg/m2 qd, d-8~d-6 intravenous infusion
- Busulfan 0.8mg/kg q6h d-5~d-3 intravenous infusion
integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-TOther
- RT regimen: localized high dose RT: 3-6Gy/fraction*5fractions
- Reduced dose SEAM regimen (CNS uninvolved):
- Simustine 250mg/m2 d-6 orally
- Cytarabine 200mg/m2 q12h d-5~d-4 intravenous infusion
- Etoposide 100mg/m2 q12h d-5~d-4 intravenous infusion
- Melphalan 140mg/m2 q12h d-3 intravenous infusion
- TB regimen (CNS involvement):
- Thiotepa 250mg/m2 qd, d-8~d-6 intravenous infusion
- Busulfan 0.8mg/kg q6h d-5~d-3 intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (PET/CT-, ctDNA+) | Experimental | 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. Receives: Other: integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T |
| Cohort 2 (PET/CT+, ctDNA+) | Experimental | 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. Receives: Other: integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate(CRR)
The rate of patients who achieved CR 3 months after CAR-T infusion
Measured: At the end of 3 months after CAR-T infusion
Secondary outcomes (4)
Major adverse reactions
The safety and tolerability of the therapeutic regimen measured by the major adverse events.
Measured: From enrollment to 1 month after CAR-T infusion of last patient
Time to bone marrow hematopoietic reconstitution
The time of bone marrow hematopoietic reconstitution after stem cell infusion
Measured: From enrollment to 3 months after stem cell infusion of last patient
2-year progression-free survival(PFS)
PFS will be assessed from the first date of radiotherapy to the progression of the disease, death, or last follow-up.
Measured: From enrollment to 2-year after the end of last patient's treatment
2-year overall survival(OS)
OS will be assessed from the first date of radiotherapy to death from any cause or last follow-up
Measured: From enrollment to 2-year after the end of last patient's treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start10 Dec 2024
- Primary completion10 Dec 2028 (estimated)
- Study completion10 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059741
- Sponsor's protocol ID
- 2024415
- Status last verified
- Jul 2025
- First submitted
- 7 Nov 2024
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07059741
- Acronym / sponsor ID
- 2024415
- Keywords
- Radiotherapy, autologous stem cell transplantation, Relapsed and refractory, circulating tumor DNA, Chimeric antigen receptor T-cell therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 10 Dec 2028 (estimated)
- Study completion
- 10 Dec 2028 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (PET/CT-, ctDNA+) | Experimental | Other: integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-TPatients 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. |
| Cohort 2 (PET/CT+, ctDNA+) | Experimental | Other: integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-TPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T1. RT regimen: localized low dose RT: 1-1.5Gy/fraction*5fractions 2. Reduced dose SEAM regimen (CNS uninvolved): * Simustine 250mg/m2 d-6 orally * Cytarabine 200mg/m2 q12h d-5~d-4 intravenous infusion * Etoposide 100mg/m2 q12h d-5~d-4 intravenous infusion * Melphalan 140mg/m2 q12h d-3 intravenous infusion 3. TB regimen (CNS involvement): * Thiotepa 250mg/m2 qd, d-8~d-6 intravenous infusion * Busulfan 0.8mg/kg q6h d-5~d-3 intravenous infusion | Other | Cohort 1 (PET/CT-, ctDNA+) |
| integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T1. RT regimen: localized high dose RT: 3-6Gy/fraction*5fractions 2. Reduced dose SEAM regimen (CNS uninvolved): * Simustine 250mg/m2 d-6 orally * Cytarabine 200mg/m2 q12h d-5~d-4 intravenous infusion * Etoposide 100mg/m2 q12h d-5~d-4 intravenous infusion * Melphalan 140mg/m2 q12h d-3 intravenous infusion 3. TB regimen (CNS involvement): * Thiotepa 250mg/m2 qd, d-8~d-6 intravenous infusion * Busulfan 0.8mg/kg q6h d-5~d-3 intravenous infusion | Other | Cohort 2 (PET/CT+, ctDNA+) |
Primary outcome
Complete remission rate(CRR)
Time frame: At the end of 3 months after CAR-T infusion
The rate of patients who achieved CR 3 months after CAR-T infusion
4 secondary outcomes
Major adverse reactions
Time frame: From enrollment to 1 month after CAR-T infusion of last patient
Time to bone marrow hematopoietic reconstitution
Time frame: From enrollment to 3 months after stem cell infusion of last patient
2-year progression-free survival(PFS)
Time frame: From enrollment to 2-year after the end of last patient's treatment
2-year overall survival(OS)
Time frame: From enrollment to 2-year after the end of last patient's treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T and integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T in people with Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changju Qu (67781856, qcj310@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate(CRR) (time frame: At the end of 3 months after CAR-T infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.