Large B-Cell LymphomaNCT07236203
Predictive Factors for the Efficacy of CD19 CAR-T Therapy in Relapsed/Refractory Large B-Cell Lymphoma: A Clinical Study
An observational study of Large B-Cell Lymphoma, run by Fudan University at 1 site in China.
Trial summary
This is a single-center real-world study aiming to explore predictive factors for the efficacy of CAR-T therapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Large B-Cell Lymphoma
- What is being tested?
- CAR-T
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 29 Feb 2024to 30 Aug 2027
- Phase
- Observational
- 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
Study population: The investigators identified patients with Relapsed/refractory large B-cell lymphoma who could be used and who were willing to receive CAR-T
Who may be able to join
- Pathological diagnosis confirmed as large B-cell lymphoma
- Patients with relapsed or refractory large B-cell lymphoma (R/R DLBCL) after receiving second-line or above systemic treatment
- Intend to use CAR-T products approved by NMPA for the treatment of R/R LBCL.
- Understand and voluntarily sign a written informed consent form. For patients without full civil capacity, their guardians must be informed and sign the corresponding informed consent form and note the date, as for the patient himself, informed consent may be obtained based on the specific circumstances.
Who cannot join
- Poor patient compliance
- During pregnancy or lactation
- After judgment by the researcher, the patient has other unsuitable conditions for inclusion 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
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200231
Chuanxu Liu, M.D, 021-64175590, liuchuanxu@shca.org.cn
About this study
This is a single-center real-world study aiming to explore predictive factors for the efficacy of CAR-T therapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).
Read the detailed description
This single-center, prospective, single-arm phase II observational study aims to investigate multidimensional correlations between clinical baseline characteristics, tumor biological profiles, dynamic changes in CAR-T cell subsets, immune microenvironment features, and therapeutic outcomes in patients with relapsed/refractory diffuse large B-cell lymphoma (LBCL). The study will enroll 80 participants who will receive a standardized 90-day CAR-T therapy regimen. Post-intervention management will be stratified based on the results of treatment efficacy and transplant evaluation: patients failing to achieve complete remission (CR) or exhibiting progressive disease (PD) during therapy may receive investigator-determined salvage therapies, while responders will transition to long-term follow-up. The primary endpoint is to explore predictors of CAR-T efficacy through multivariate analysis of patients' clinical baseline characteristics, tumor characteristics, CAR-T cell subsets and their dynamic changes, and immune microenvironment.
- Conditions
- Large B-Cell Lymphoma
- Being tested
- CAR-T
- Keywords
- CD19 CAR-T, Recurrent/Refractory Large B-Cell Lymphoma, Predictive factors for therapeutic efficacy
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-TDrug
CD19 CAR-T
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | CAR-T Receives: Drug: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
explore predictors of CAR-T efficacy
explore predictors of CAR-T efficacy through multivariate analysis of patients' clinical baseline characteristics, tumor characteristics, CAR-T cell subsets and their dynamic changes, and immune microenvironment.
Measured: Baseline; 30 days post-infusion, 90 days post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start29 Feb 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Tao, Fudan University
- Investigators
- Chuan xu Liu, M.D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236203
- Sponsor's protocol ID
- CD19 CAR-T
- Status last verified
- Nov 2025
- First submitted
- 25 May 2025
- Last updated
- 19 Nov 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors for the Efficacy of CD19 CAR-T Therapy in Relapsed/Refractory Large B-Cell Lymphoma: A Clinical Study
- ClinicalTrials.gov ID
- NCT07236203
- Acronym / sponsor ID
- CD19 CAR-T
- Conditions
- Large B-Cell Lymphoma
- Keywords
- CD19 CAR-T, Recurrent/Refractory Large B-Cell Lymphoma, Predictive factors for therapeutic efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 19 Nov 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 is a single-center real-world study aiming to explore predictive factors for the efficacy of CAR-T therapy in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).
Detailed description
This single-center, prospective, single-arm phase II observational study aims to investigate multidimensional correlations between clinical baseline characteristics, tumor biological profiles, dynamic changes in CAR-T cell subsets, immune microenvironment features, and therapeutic outcomes in patients with relapsed/refractory diffuse large B-cell lymphoma (LBCL). The study will enroll 80 participants who will receive a standardized 90-day CAR-T therapy regimen. Post-intervention management will be stratified based on the results of treatment efficacy and transplant evaluation: patients failing to achieve complete remission (CR) or exhibiting progressive disease (PD) during therapy may receive investigator-determined salvage therapies, while responders will transition to long-term follow-up. The primary endpoint is to explore predictors of CAR-T efficacy through multivariate analysis of patients' clinical baseline characteristics, tumor characteristics, CAR-T cell subsets and their dynamic changes, and immune microenvironment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: CAR-TCAR-T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators identified patients with Relapsed/refractory large B-cell lymphoma who could be used and who were willing to receive CAR-T
Key inclusion criteria (4 listed)
- Pathological diagnosis confirmed as large B-cell lymphoma
- Patients with relapsed or refractory large B-cell lymphoma (R/R DLBCL) after receiving second-line or above systemic treatment
- Intend to use CAR-T products approved by NMPA for the treatment of R/R LBCL.
- Understand and voluntarily sign a written informed consent form. For patients without full civil capacity, their guardians must be informed and sign the corresponding informed consent form and note the date, as for the patient himself, informed consent may be obtained based on the specific circumstances.
Key exclusion criteria (3 listed)
- Poor patient compliance
- During pregnancy or lactation
- After judgment by the researcher, the patient has other unsuitable conditions for inclusion in the study.
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 |
|---|---|---|
| CAR-TCD19 CAR-T | Drug | Treatment group |
Primary outcome
explore predictors of CAR-T efficacy
Time frame: Baseline; 30 days post-infusion, 90 days post-infusion
explore predictors of CAR-T efficacy through multivariate analysis of patients' clinical baseline characteristics, tumor characteristics, CAR-T cell subsets and their dynamic changes, and immune microenvironment.
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 19 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Chuan xu Liu, M.D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Large B-Cell Lymphoma, run by Fudan 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 4 inclusion and 3 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 19 Nov 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 Chuanxu Liu, M.D (021-64175590, liuchuanxu@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
explore predictors of CAR-T efficacy (time frame: Baseline; 30 days post-infusion, 90 days post-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 19 Nov 2025.