Autologous CD19/BCMA Dual-Target CAR-T (Beijing Boren Hospital) in Idiopathic Inflammatory Myopathies: NCT07361094 Clinical Landscape Report 2026
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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
Recruiting
Recruitment status
12
Planned enrollment
2028-06-01
Primary-completion proxy
Executive view
NCT07361094 evaluates Autologous CD19/BCMA Dual-Target CAR-T (Beijing Boren Hospital) in Idiopathic Inflammatory Myopathies. The disclosed sponsor is Beijing Gaobo Boren Hospital Co., Ltd., the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and adverse events of special interest (AESIs: CRS and ICANS), graded per CTCAE v5.0 and ASTCT 2019 criteria, assessed over From Day 0 through Month 24 after infusion (including Day 1-28 observation and Month 2-24 follow-up)..
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 NCT07361094 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Idiopathic Inflammatory Myopathies landscape. Drug & Asset MCP drug_fetch was queried for Autologous CD19/BCMA Dual-Target CAR-T (Beijing Boren Hospital), while Company & Deal Intelligence MCP organization_fetch was queried for Beijing Gaobo Boren Hospital Co., Ltd..
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 |
|---|---|---|---|---|---|---|
| NCT07361094 | Autologous CD19/BCMA Dual-Target CAR-T (Beijing Boren Hospital) | Phase 1 / Recruiting | Beijing Gaobo Boren Hospital Co., Ltd. | China | Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), laboratory abnormalitie… From Day 0 through Month 24 after infusion (including Day 1-28 observ… | 2028-06-01 |
| NCT07516639 | ISH-0613 | Phase 1 / Not yet recruiting | Sunho (China) Biopharmaceutical Co., Ltd. | China | Number of participants with treatment-emergent adverse events as assessed by CTCAE v6.0 baseline through day 57 | 2026-12-31 |
| NCT07517536 | CHT-105 | Not Applicable / Enrolling by invitation | Nanjing Drum Tower Hospital | China | Safety of CHT105 Injection in Subjects with Refractory Lupus Nephritis From enrollment to the end of treatment at 52 weeks | 2028-01-01 |
| NCT07512947 | YK012 | Phase 1 / Not yet recruiting | Wuhan Xiehe Hospital Tower | China | Incidence of Dose-Limiting Toxicities (DLTs) From first dose through Day 35 | 2028-03-30 |
| NCT07507201 | Universal allogeneic anti-CD19/BCMA CAR T-cells(The Children's Hospital of Zhejiang University School of Medicine) | Early Phase 1 / Recruiting | The Children's Hospital of Zhejiang University School of Medicine | China | Incidence of Dose-Limiting Toxicities (DLTs) Day 0 to Day 28 post-infusion. | 2028-12-01 |
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
NCT07361094 is a Phase 1, recruiting study with 12 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and adverse events of special interest (AESIs: CRS and ICANS), graded per CTCAE v5.0 and ASTCT 2019 criteria” over “From Day 0 through Month 24 after infusion (including Day 1-28 observation and Month 2-24 follow-up)..” The retrieved endpoint description is: AEs will be collected from the time of signing the informed consent form through 2 years after CAR-T infusion or the exit visit, whichever occurs first; if disease relapse occurs within 6 months after infusion, AEs will be collected as much as possible through 6 months post-infusion with participant cooperation. All AEs will be coded using MedDRA and summarized by System Organ Class (SOC) and Preferred Term (PT) as the number and percentage of participants with events. AE severity will be summarized using CTCAE v5.0. CRS and ICANS will be summarized using ASTCT 2019 grading criteria. AESIs (including CRS and ICA….
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 12 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 Idiopathic Inflammatory Myopathies. These records do not establish direct evidence for NCT07361094 unless the registration number matches.
A PHASE 2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE CLINICAL EFFECT, PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY PROFILE OF PF 06823859 IN A…
Phase 2; n=8; Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12(Least Squares Mean): Least Square Mean Difference = 0.5(90% CI, -3.7 to 4.6), P-Value = 0.8243; Change From Baseline in Type 1 Interferon (IFN) Gene Signature (GS) Score in Lesional Skin at Week 12(Least Squares Mean): Least Square Mean Difference = 0.5(90% CI, -3.7 to 4.6), P-Value = 0.8243 Source: https://clinicaltrials.gov/ct2/show/results/NCT05879718
A Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-6194 in Adult Participants With Systemic Lupus Erythematosus
Phase 2; n=149; Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28 = 10 Participants ; Number of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI-4) Response at Week 28 = 15 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT06161116
Dapagliflozin in lupus nephritis: renal and hematologic outcomes from a randomized controlled trial
Phase 2; n=79; eGFR = -2.0 ml/min/1.73 m2 Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42549085/
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
Autologous CD19/BCMA Dual-Target CAR-T (Beijing Boren Hospital) is indexed as Autologous CAR-T with BCMA x CD19 biology and a global stage of Phase 1. The asset profile lists Beijing Gaobo Boren Hospital Co., Ltd. as an originator or developer.
Beijing Gaobo Boren Hospital Co., Ltd. is indexed in China with the website http://borenhospital.com. The organization record is used to resolve sponsor identity. The record lists 11 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 Autologous CD19/BCMA Dual-Target CAR-T (Beijing Boren Hospital) 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: NCT07361094
Protocol source: https://clinicaltrials.gov/study/NCT07361094
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.
Autologous CD19/BCMA Dual-Target CAR-T (Beijing Boren Hospital) in Idiopathic Inflammatory Myopathies is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and adverse events of special interest (AESIs: CRS and ICANS), graded per CTCAE v5.0 and ASTCT 2019 criteria and 2028-06-01 the leading decision points.
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