Lymphoma, B-CellPhase 2NCT06381830
Clinical Study of CAR-T Cell Therapy Following ASCT for R/R B-cell Non-Hodgkin's Lymphoma
A Phase 2 study testing Apheresis, Autologous Stem Cell Transplantation and CAR-T Cell Therapy in people with Lymphoma, B-Cell and Autologous Stem Cell Transplantation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma, B-Cell, Autologous Stem Cell Transplantation
- What is being tested?
- Apheresis, Autologous Stem Cell Transplantation and CAR-T Cell Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-65 years.
- Pathological immunohistochemistry or flow cytometry confirmed that R/ R Large B-cell Non-Hodgkin's Lymphoma with measurable (the longest diameter greater than 1.5cm and the longest vertical diameter greater than 1.0cm) lesions.
- Previously treated with 1 or more lines of therapy.
- ECOG≤2#.
- The main organ functions need to meet the following conditions:LVEF≥50%;CCr≥30 ml/min; ALT and AST≤3 times normal range.
- Hematopoietic function needs to meet the following conditions: platelet count≥45×10^9/L; hemoglobin≥8.0 g/dL; absolute neutrophil count≥1.0×10^9/L.
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- Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up one year period of the study.
- Estimated survival time ≥3 months.
- Voluntary signing of informed consent and good compliance.
Who cannot join
- Have used immunosuppressants or hormones within 2 weeks prior to apheresis, or have to use immunosuppressants or hormones after signing informed consent.
- The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
- Active hepatitis B or active hepatitis C.
- HIV infection.
- Have received CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation prior to signing the informed consent.
- Prior malignancy (other than Relapsed Refractory B-cell Non-Hodgkin's Lymphoma).
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- Pregnant or breasting-feeding women.
- There is evidence of complications or medical conditions that could interfere with the conduct of the study or put patients at serious risk, including but not limited to serious cardiovascular disease.
- Conditions deemed by the researchers to be inappropriate for participation.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
About this study
Official title: Clinical Study of the Efficacy and Safety of Chimeric Antigen Receptor T-cell Therapy Following Autologous Stem Cell Transplantation for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.
Read the detailed description
Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.
- Being tested
- Apheresis, Autologous Stem Cell Transplantation, CAR-T Cell Therapy
- Keywords
- Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, CAR-T Cell Therapy, Autologous Stem Cell Transplantation
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApheresisOther
Participants will undergo two separate apheresis procedures, including: G-CSF primed hematopoietic stem cell collection and peripheral blood mononuclear cell apheresis for CAR-T cell manufacturing.
Autologous Stem Cell TransplantationOther
Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10^6 CD34+ stem cells/kilogram.
CAR-T Cell TherapyDrug
Also called Chimeric Antigen Receptor T-cell
CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10^6 CAR-T/kg，ivgtt).
| Study group | Role | What they receive |
|---|---|---|
| ASCT+CAR-T | Experimental | Participants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy. Receives: Other: Apheresis; Other: Autologous Stem Cell Transplantation; Drug: CAR-T Cell Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Number of participants who will have achieved response after ASCT plus CAR-T cell Therapy.
Measured: Up to 24 months
Progression-free Survival（PFS）
PFS is defined as the time from ASCT to progression, death or the last follow-up point
Measured: Up to 24 months
Secondary outcomes (4)
Duration of Response(DOR)
To measure the duration of response to ASCT Plus CAR-T Cell Therapy over a follow-up period of 24 months
Measured: Up to 24 months
Complete Response Rate
Number of participants who will have achieved complete response after ASCT plus CAR-T cell Therapy.
Measured: Up to 24 months
Overall Survival（OS）
OS will be assessed from ASCT plus CAR-T cell therapy to death or last follow-up.
Measured: Up to 24 months
Adverse events profile
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Why it stopped: The study was terminated due to changes in national policy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, B-CellStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, Suzhou Hongci Hematology Hospital, Suzhou, China
- Responsible party
- Sponsor
- Investigators
- Deipei Wu, M.D., Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381830
- Sponsor's protocol ID
- ASCT+CART
- Status last verified
- May 2026
- First submitted
- 19 Apr 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Efficacy and Safety of Chimeric Antigen Receptor T-cell Therapy Following Autologous Stem Cell Transplantation for Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT06381830
- Acronym / sponsor ID
- ASCT+CART
- Keywords
- Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma, CAR-T Cell Therapy, Autologous Stem Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to changes in national policy.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd, Suzhou Hongci Hematology Hospital, Suzhou, China
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 24 Apr 2024 (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.
The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.
Detailed description
Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCT+CAR-T | Experimental | Other: Apheresis, Other: Autologous Stem Cell Transplantation, Drug: CAR-T Cell TherapyParticipants will receive autologous stem cell transplantation followed by chimeric antigen receptor T (CAR-T) cell therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-65 years.
- Pathological immunohistochemistry or flow cytometry confirmed that R/ R Large B-cell Non-Hodgkin's Lymphoma with measurable (the longest diameter greater than 1.5cm and the longest vertical diameter greater than 1.0cm) lesions.
- Previously treated with 1 or more lines of therapy.
- ECOG≤2#.
- The main organ functions need to meet the following conditions:LVEF≥50%;CCr≥30 ml/min; ALT and AST≤3 times normal range.
Key exclusion criteria (9 listed)
- Have used immunosuppressants or hormones within 2 weeks prior to apheresis, or have to use immunosuppressants or hormones after signing informed consent.
- The presence of bacterial, fungal, viral, mycoplasma or other types of infection that, in the judgment of the investigator, are difficult to control.
- Active hepatitis B or active hepatitis C.
- HIV infection.
- Have received CAR-T cell therapy or allogeneic hematopoietic stem cell transplantation prior to signing the informed consent.
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 |
|---|---|---|
| ApheresisParticipants will undergo two separate apheresis procedures, including: G-CSF primed hematopoietic stem cell collection and peripheral blood mononuclear cell apheresis for CAR-T cell manufacturing. | Other | ASCT+CAR-T |
| Autologous Stem Cell TransplantationParticipants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10^6 CD34+ stem cells/kilogram. | Other | ASCT+CAR-T |
| CAR-T Cell TherapyAlso: Chimeric Antigen Receptor T-cellCAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10^6 CAR-T/kg，ivgtt). | Drug | ASCT+CAR-T |
Primary outcome
Overall Response Rate (ORR)
Time frame: Up to 24 months
Number of participants who will have achieved response after ASCT plus CAR-T cell Therapy.
Progression-free Survival（PFS）
Time frame: Up to 24 months
PFS is defined as the time from ASCT to progression, death or the last follow-up point
4 secondary outcomes
Duration of Response(DOR)
Time frame: Up to 24 months
Complete Response Rate
Time frame: Up to 24 months
Overall Survival（OS）
Time frame: Up to 24 months
Adverse events profile
Time frame: Up to 24 months
Results and safety
The study was stopped early (reason given: The study was terminated due to changes in national policy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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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. This study is not recruiting at the moment.
Deipei Wu, M.D. study chair
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apheresis, Autologous Stem Cell Transplantation and CAR-T Cell Therapy in people with Lymphoma, B-Cell and Autologous Stem Cell Transplantation, 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 9 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: stopped early, as of the sponsor's last update on 5 Jun 2026. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to changes in national policy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 5 Jun 2026.