NCT07441291 Autologous CD19 CAR-T cells(Peking University People's Hospital) Ph-Like Acute Lymphoblastic Leukemia Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07441291 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: 24 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07441291 is a hot trial to watch
Ph-Like Acute Lymphoblastic Leukemia is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07441291 is notable because it evaluates Autologous CD19 CAR-T cells(Peking University People's Hospital) in a Phase 3 design sponsored by Peking University People's 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 | NCT07441291 |
| Official title | CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT |
| Phase / status | Phase 3 / Recruiting |
| Intervention | Autologous CD19 CAR-T cells(Peking University People's Hospital) |
| Sponsor | Peking University People's Hospital |
| Geography | China |
| Enrollment | not reported |
| Primary endpoint | 3-month MRD negativity rate |
| Endpoint time frame | 3-month |
| Primary completion / readout proxy | not reported |
Protocol design and endpoint interpretation
This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT). Patients (aged 3- The primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity. The study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment was not reported; study geography in 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.
- 3-month MRD negativity rate(3-month) — MRD negativity rate of MFC
Readout outlook and evidence gap
The current protocol points to not reported 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: Autologous CD19 CAR-T cells(Peking University People's 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: Peking University People's 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
NCT07441291 provides a focused lens on Ph-Like Acute Lymphoblastic Leukemia development. Its value will be determined by whether Autologous CD19 CAR-T cells(Peking University People's Hospital) can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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