Predictors of response to CD19 CAR-T therapy in relapsed/refractory large B‑cell lymphoma
Official title: Predictive Factors for the Efficacy of CD19 CAR-T Therapy in Relapsed/Refractory Large B-Cell Lymphoma: A Clinical Study
Run by Fudan University · NCT07236203 · Data updated 2026-11-12
This study will see if clinical features, tumor biology, and immune cell changes can predict who responds to CD19 CAR‑T therapy for relapsed/refractory large B‑cell lymphoma.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | February 29, 2024 |
| Main results expected | August 30, 2026 |
| Study ends | August 30, 2027 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT07236203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with pathologically confirmed relapsed or refractory large B‑cell lymphoma after at least second-line systemic therapy who plan to receive an NMPA‑approved CD19 CAR‑T product and can provide informed consent.
✕Probably not a fit
Patients who are pregnant or breastfeeding, have poor compliance, or are judged by investigators to have other unsuitable conditions are unlikely to benefit or be eligible for participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective, single-arm observational study enrolling 80 patients with relapsed/refractory large B‑cell lymphoma who will receive a standardized 90-day CD19 CAR‑T therapy regimen. Investigators will collect baseline clinical data, tumor biological profiles, serial CAR‑T cell subset measurements, and immune microenvironment features. Outcomes and response status will be used to perform multivariate analyses to identify predictors of treatment efficacy. Non-responders may receive investigator-determined salvage therapies while responders enter long-term follow-up.
Why it matters
Potential benefit: If successful, the results could help clinicians predict who is most likely to benefit from CD19 CAR‑T and guide personalized post-CAR‑T management.
How similar studies have gone: Previous CAR‑T research has identified some clinical and tumor factors associated with response, but comprehensive multidimensional predictive models remain exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathological diagnosis confirmed as large B-cell lymphoma 2. Patients with relapsed or refractory large B-cell lymphoma (R/R DLBCL) after receiving second-line or above systemic treatment 3. Intend to use CAR-T products approved by NMPA for the treatment of R/R LBCL. 4. 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. Exclusion Criteria: 1. Poor patient compliance 2. During pregnancy or lactation 3. After judgment by the researcher, the patient has other unsuitable conditions for inclusion in the study.
Where it's running
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Chuan xu Liu, M.D — Fudan University
- Study coordinator: Chuanxu Liu, M.D
- Email: liuchuanxu@shca.org.cn
- Phone: 021-64175590
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.