NCT07461831 CD19/CD22-bispecific CAR-T cells(Beijing Tongren Hospital) Large B-cell lymphoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07461831 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 27 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07461831 is a hot trial to watch
Large B-cell lymphoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07461831 is notable because it evaluates CD19/CD22-bispecific CAR-T cells(Beijing Tongren Hospital) in a Phase 2 design sponsored by Beijing Tongren Hospital. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07461831 |
| Official title | CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma |
| Phase / status | Phase 2 / Active, not recruiting |
| Intervention | CD19/CD22-bispecific CAR-T cells(Beijing Tongren Hospital) |
| Sponsor | Beijing Tongren Hospital |
| Geography | China |
| Enrollment | 100 |
| Primary endpoint | best overall response rate (ORR) as of 3 months post-CAR-T cells infusion |
| Endpoint time frame | From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion |
| Primary completion / readout proxy | 2026-04-18 |
Protocol design and endpoint interpretation
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory Large B cell lymphoma.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of 100 participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- best overall response rate (ORR) as of 3 months post-CAR-T cells infusion (From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion) — Overall response rate means sum of complete response rate and partial response rate
Readout outlook and evidence gap
The current protocol points to 2026-04-18 as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: CD19/CD22-bispecific CAR-T cells(Beijing Tongren Hospital) is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Beijing Tongren Hospital is resolved to a normalized organization record in Beijing Shi, China. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07461831 provides a focused lens on Large B-cell lymphoma development. Its value will be determined by whether CD19/CD22-bispecific CAR-T cells(Beijing Tongren Hospital) can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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