GD2/B7H3 CAR T-cell therapy(Yake Biotechnology) NCT06836505 Clinica…

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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: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 1/2

Clinical phase

Recruiting

Recruitment status

not reported

Planned enrollment

2027-12-12

Primary-completion proxy

Executive view

NCT06836505 evaluates GD2/B7H3 CAR T-cell therapy(Yake Biotechnology) in Refractory Neuroblastoma. The disclosed sponsor is Sun Yat-Sen University, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is To evaluate the safety of CAR-T cells in relapsed/refractory neuroblastoma and desmoplastic small round cell tumor patients., assessed over From enrollment to the end of treatment at 1 year.

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 NCT06836505 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Refractory Neuroblastoma landscape. Drug & Asset MCP drug_fetch was queried for GD2/B7H3 CAR T-cell therapy(Yake Biotechnology), while Company & Deal Intelligence MCP organization_fetch was queried for Sun Yat-Sen 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
NCT06836505	GD2/B7H3 CAR T-cell therapy(Yake Biotechnology)	Phase 1/2 / Recruiting	Sun Yat-Sen University	China	To evaluate the safety of CAR-T cells in relapsed/refractory neuroblastoma and desmoplastic small round cell tumor pati… From enrollment to the end of treatment at 1 year	2027-12-12
NCT07052370	Mesna	Phase 1 / Recruiting	St. Jude Children's Research Hospital, Inc.	United States	Number of participants experiencing grade 3-4 GVHD and/or transplant related mortality (TRM). Within 100 days post-transplant infusion	2028-12-01
NCT07052383	DIT-309	Phase 1 / Suspended	Tcelltech Inc.	China	Safety：Incidence of Dose Limiting Toxicity (DLT) 28 days after the first DIT309 infusion.	2027-10-10
NCT07049848	Atezolizumab	Phase 2 / Recruiting	The University of Texas MD Anderson Cancer Center	United States	Safety and Adverse Events (AEs) Through study completion; an average of 1 year.	2028-01-01
NCT07048249	Romiplostim	Early Phase 1 / Recruiting	Children's Hospital & Medical Center	United States	Number of evaluable participants (11 or fewer of 26) that develop CIT during the continuation phase of compressed-inter… 52 weeks	2027-01-01

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.

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Protocol design and endpoint interpretation

NCT06836505 is a Phase 1/2, recruiting study with not reported planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “To evaluate the safety of CAR-T cells in relapsed/refractory neuroblastoma and desmoplastic small round cell tumor patients.” over “From enrollment to the end of treatment at 1 year.” The retrieved endpoint description is: 1. To evaluate the safety of the infusion of CAR T cells at different escalating/deescalating doses and establish the dose limiting toxicity (DLT) of the cellular product. Toxicity will be evaluated according to the CTC AE scale, version 4.0. DLT will be defined as any of the following that is not pre-existing, due to infection or to underlying malignancy and that may be considered possibly, probably or definitely related to the study cellular products. (1) Non-hematologic DLT is any grade 3 or 4 non-hematologic toxicity; (2) Hematologic DLT is defined as any grade 4 hematologic toxicity related to infusion ; (3….

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 not reported 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

0 recent result records were selected as contextual evidence for Refractory Neuroblastoma. These records do not establish direct evidence for NCT06836505 unless the registration number matches.

Indexed evidence status

No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.

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

GD2/B7H3 CAR T-cell therapy(Yake Biotechnology) is indexed as CAR-T with CD276 x GD2 biology and a global stage of Phase 1/2. The asset profile lists Shanghai Yake Biotechnology Co., Ltd as an originator or developer.

Sun Yat-Sen University is indexed in an unreported country with the website http://www.sysu.edu.cn. Sun Yat-sen University is a public university in Guangdong, People's Republic of China. The record lists 244 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 GD2/B7H3 CAR T-cell therapy(Yake Biotechnology) 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: NCT06836505
Protocol source: https://clinicaltrials.gov/study/NCT06836505
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: 15 October 2026.

GD2/B7H3 CAR T-cell therapy(Yake Biotechnology) in Refractory Neuroblastoma is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes To evaluate the safety of CAR-T cells in relapsed/refractory neuroblastoma and desmoplastic small round cell tumor patients. and 2027-12-12 the leading decision points.

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