U96-CAR-T-Cells(The First Affiliated Hospital of Soochow University) in B-Cell Leukemia: NCT07511426 Clinical Landscape Report 2026
Explore the PatSnap Life Sciences MCP marketplace
This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 1
Clinical phase
Not yet recruiting
Recruitment status
30
Planned enrollment
2027-01-07
Primary-completion proxy
Executive view
NCT07511426 evaluates U96-CAR-T-Cells(The First Affiliated Hospital of Soochow University) in B-Cell Leukemia. The disclosed sponsor is The First Affiliated Hospital of Soochow University, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Dose-limiting toxicity (DLT), assessed over Within 28 days after U96 infusion.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07511426 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider B-Cell Leukemia landscape. Drug & Asset MCP drug_fetch was queried for U96-CAR-T-Cells(The First Affiliated Hospital of Soochow University), while Company & Deal Intelligence MCP organization_fetch was queried for The First Affiliated Hospital of Soochow University.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07511426 | U96-CAR-T-Cells(The First Affiliated Hospital of Soochow University) | Phase 1 / Not yet recruiting | The First Affiliated Hospital of Soochow University | China | Dose-limiting toxicity (DLT) Within 28 days after U96 infusion | 2027-01-07 |
| NCT07581704 | Sirolimus | Phase 1 / Recruiting | University of Iowa | United States | Phase Ib: Dose limiting toxicities (DLTs) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) ver… From treatment initiation through 30 days post last dose of study tre… | 2029-06-01 |
| NCT07577206 | [68Ga]Ga-R54 | Early Phase 1 / Recruiting | National Cancer Institute | Italy | Quantitative analysis of the uptake (pharmacodynamics) of [68Ga]Ga-R54 in the neoplastic lesion by measuring the "maxim… Single time point at PET/CT imaging (Day 1) | 2027-01-01 |
| NCT07558915 | RO-7851624 | Phase 1 / Recruiting | Genentech, Inc. | Australia | Percentage of Participants With Adverse Events (AEs) Up to approximately 2 years | 2030-07-01 |
| NCT07541391 | KMA.CAR T(HaemaLogiX) | Phase 1 / Recruiting | Peter MacCallum Cancer Institute | Australia | To evaluate the safety of autologous PMCC-COE-KMA in patients with RR MM following lymphodepletion, identifying the max… From enrollment to the first 28 days after the PMCC-COE-KMA infusion | 2028-09-01 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
Reproduce the trial-to-asset workflow with PatSnap MCP
Protocol design and endpoint interpretation
NCT07511426 is a Phase 1, not yet recruiting study with 30 planned participants. Allocation is Randomized, masking is None (Open Label), and the intervention model is Sequential Assignment.
The primary endpoint is “Dose-limiting toxicity (DLT)” over “Within 28 days after U96 infusion.” The retrieved endpoint description is: Description: DLT refers to any of the following conditions occurring within 28 days after cell reinfusion that are related to cell infusion: ① Hematologic DLT: Grade 4 toxicity (excluding lymphopenia) not caused by the underlying disease and taking more than 30 days to resolve to ≤ Grade 2. ② Non-hematologic DLT: Any toxicity ≥ Grade 4 that is possibly related to CAR-T therapy, or Grade 3 toxicity that requires ≥7 days to resolve to ≤ Grade 2 or to return to baseline..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 30 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
5 recent result records were selected as contextual evidence for B-Cell Leukemia. These records do not establish direct evidence for NCT07511426 unless the registration number matches.
Open Label, Phase 2, Single-Arm Study of Selinexor, Daratumumab, Carfilzomib and Dexamethasone for High-Risk, Relapsed and Relapsed/Refractory Multiple Myeloma Patients Who Have R…
Phase 2; n=8; ORR = 75.0 percentage of participants (95% Confidence Interval, 34.9 - 96.8) Source: https://clinicaltrials.gov/ct2/show/results/NCT04756401
MATCH Treatment Subprotocol Z1E: Larotrectinib (LOXO-101) in Patients With Tumors With NTRK Fusions
Phase 2; n=16; ORR = 75 percentage of participants (90% Confidence Interval, 47.3 - 92.8) Source: https://clinicaltrials.gov/ct2/show/results/NCT06390852
A Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapse…
Phase 3; n=154; PFS(Median) = 6.34 month (95% Confidence Interval, 5.55 - 11.79); PFS(Median) = 8.11 month (95% Confidence Interval, 6.28 - 11.99) Source: https://clinicaltrials.gov/ct2/show/results/NCT04939142
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
U96-CAR-T-Cells(The First Affiliated Hospital of Soochow University) is indexed as CAR-T with target not reported biology and a global stage of Phase 1. The asset profile lists The First Affiliated Hospital of Soochow University as an originator or developer.
The First Affiliated Hospital of Soochow University is indexed in China with the website http://fyy.sdfyy.cn. The organization record is used to resolve sponsor identity. The record lists 34 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether U96-CAR-T-Cells(The First Affiliated Hospital of Soochow University) is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07511426
Protocol source: https://clinicaltrials.gov/study/NCT07511426
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.
U96-CAR-T-Cells(The First Affiliated Hospital of Soochow University) in B-Cell Leukemia is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Dose-limiting toxicity (DLT) and 2027-01-07 the leading decision points.
Build and refresh clinical landscape reports with PatSnap MCP
