Immunology
CD19 CAR-T can reset the immune system in lupus — sometimes durably, sometimes not. The difference between remission and relapse is not the construct alone; it's whether the therapy clears the sanctuaries and resets reconstitution.
Durable Immune Reset in Autoimmune Cell Therapy
- DOSSIEROne framework across SLE, myasthenia gravis, NMOSD, systemic sclerosis, myositis and type 1 diabetes.
- WORKBOOK24 sheets — our most extensive. 90 claims with verbatim excerpts; 248 itemized exclusions; safety (CRS/ICANS/secondary malignancy).
- AUDITRelease-ready · grounded. Every premise re-verified against source, zero retractions.
- HYPOTHESES11 falsifiable, dated; a precision finding on early durability (YTB323 cohort).
Exactly what's inside Durable Immune Reset in Autoimmune Cell Therapy.
The full research-report table of contents and every one of the 24 tables in the evidence workbook — the real structure of what you license, not a teaser.
- Report Scope & Evidence Integrity Statement
- Claim Boundary & FDA-Category Discipline
- 2026 Translational Signal Update & Evidence Refresh Addendum
- Executive Summary
- Decision Snapshot
- Buyer Decision Cheat Sheet (by platform AND indication)
- Source Quality Dashboard
- The Persistence × Sanctuary × Reconstitution Model
- Platform Comparison & Evidence Maturity Matrix (modality-level)
- Relapse-Mode Convergence Map
- Key Findings & Quantitative Evidence
- Mechanistic Insights
- Safety: CRS, ICANS, Infection, Secondary Malignancy, Cytopenia, GvHD
- Durability & Indication Gradient
- Persistence & Antigen Dynamics
- Manufacturing, Scalability & CMC
- Regulatory Pathway & Classification
- Indication-Specific Deep Dives
- Oncology ↔ Autoimmune Cross-Domain Translation
- Prioritized Non-Obvious Hypotheses (2026–2028)
- Most Valuable Next Studies / Validation Strategies
- Validation & Falsification Gate Map
- Company / Platform / Funding Landscape
- Commercial & Market Access
- Strategic Recommendations
- Final Judgment
- Expert Review & Validation Attestation
- Appendix
- References
Workbook Guide
An orientation to the workbook — its scope, how the claim counts reconcile, and the audit posture.
Claim Ledger
Every factual claim in the report, independently re-verified against its primary source, each carrying a support verdict and a recalibrated evidence grade.
Evidence Table
The full registry of cited sources — PMIDs, NCTs and DOIs — with metadata, resolved live against the primary record.
Source Support Verdicts
The verbatim source excerpt behind each claim, with an independent verdict on whether the source actually supports it.
Source Quality Summary
A reconciled view of source quality across the evidence base, with the grading rationale.
Platform Scorecard
Programs or modalities scored on the framework's axes — a structured, side-by-side comparison (expert, ordinal, non-evidentiary).
In this dossier: Ordinal maturity 0-4 = expert/non-evidentiary; does not drive standalone efficacy claims (Immunology §2A).
Indication Scorecard
Programs or modalities scored on the framework's axes — a structured, side-by-side comparison (expert, ordinal, non-evidentiary).
PSR Scorecard
Programs or modalities scored on the framework's axes — a structured, side-by-side comparison (expert, ordinal, non-evidentiary).
Figure Source Map
The provenance of every figure — its underlying data and how it was produced.
Figure Attempt Ledger
The provenance of every figure — its underlying data and how it was produced.
In this dossier: All figures RENDERED — none PENDING (source artifact had 14 PENDING).
Hypotheses Ledger
The forward-looking, falsifiable hypotheses — each with a predicted readout and an explicit disconfirming test.
Most Valuable Next Studies
The highest-leverage experiments to run next, prioritized — a ready-made research agenda.
Validation-Falsification Gat
A structured table within the evidence workbook.
In this dossier: 13 Validation-Falsification Gates
Safety Tracker
A structured tracker of the programs, signals and evidence in this dimension of the analysis.
Manufacturing-CMC Matrix
A structured map across this dimension of the analysis.
Biomarker-Endpoint Tracker
How candidate biomarkers map to clinical endpoints — the bridge from a measurement to an outcome.
Regulatory Tracker
Regulatory designations and pathways relevant to each program — noting that a designation is never an approval.
Company-Platform-Funding
A structured table within the evidence workbook.
Trial-Registry Tracker
A structured tracker of the programs, signals and evidence in this dimension of the analysis.
In this dossier: All NCTs opened & confirmed on ClinicalTrials.gov v2 (2026-06-04).
External 2026 Update Sources
A structured table within the evidence workbook.
In this dossier: Gate G2 — new 2026 forward search + IR/news/regulatory sweep; search date 2026-06-04.
Expert Review-Validation
A structured table within the evidence workbook.
In this dossier: Attestation item
Gate Compliance Ledger
A structured table within the evidence workbook.
Excluded Claims
Every claim we considered and removed, with the reason — showing the work, including what didn't make the cut.
In this dossier: 246 excluded claims; 11 recovered to body + 20 to premises; remainder excluded with reason. Reconciles 89+246=335.
Salvage Ledger
Claims recovered from the excluded set after deeper verification.
In this dossier: Original section
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Every claim resolves to a primary source.
This dossier ships with its independent diligence audit. Evidence is labelled Established / Inferred / Hypothesis. A surrogate is never equated with outcome; a designation is never an approval.
Zemi Research publishes independent, pre-packaged research reports delivered as digital downloads (PDF + spreadsheet). These are information products — not medical, clinical, investment, legal, or professional advice; not a consulting, advisory, or regulated service; and they create no professional-client relationship. Provided for general informational use by industry professionals.