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Trials — ASH 2026

The primary artifact of this vault: one Markdown file per trial / readout. ASH 2026 is a clinical-readout meeting, so the unit of analysis is the trial — not the speaker, not the tool, not the company. Same per-trial schema as ASCO 2026 and ESMO 2026; ASH adds an explicit cell-and-gene-therapy sub-axis and a non-malignant heme sub-axis.

Status: Template + master index. Per-trial pages will be populated in two waves: (1) regular abstracts upon Blood-supplement release on Nov 4, 2026, 9:00 AM ET; (2) Late-Breaking Abstracts on ~Nov 24, 2026, 12:00 noon ET. Pre-meeting stubs flagged *expected, subject to embargo* are sourced from company toplines, EHA 2026 mid-year readouts, ASCO 2026 heme subset, and analyst preview pieces; numbers can shift on the actual abstract reveal.

Per-trial template

Each trial file (e.g., frontmind-update.md) follows this schema. Copy and fill:

# <Trial acronym / name> — <Drug regimen, indication, line>

> **Abstract:** <abstract #, e.g., LBA-1 / Plenary #6 / Abstract 234> · **Session:** <session name, date, time CT, hall> · **Embargo:** <date>

## At a glance

- **Sponsor:** <pharma / cooperative group>
- **PI / presenter:** <name, institution>
- **NCT ID:** <NCTxxxxxxxx>
- **Phase:** <1 / 1b / 2 / 2-3 / 3 / pivotal / registry>
- **Design:** <arms, randomization, blinding>
- **N:** <enrolled / analyzed>
- **Primary endpoint(s):** <PFS / OS / EFS / CR rate / MRD-neg / VOC-free / FVIII expression>
- **Comparator:** <SOC / placebo / active comparator / historical>
- **Indication:** <heme disease, subtype, biomarker / cytogenetic selection>
- **Line:** <frontline / 1L / 2L / 3L+ / maintenance / post-transplant / post-CAR-T>

## Headline result

<One paragraph. Numbers + HR + p-value if known. If pre-embargo, mark
`*expected per <company> topline <date>*` or `*pre-embargo per <analyst source>*`
or `*EHA 2026 readout, ASH 2026 update expected*`.>

## Mechanism / class

<Drug class, target, prior approvals if any. For CAR-T: construct details (costim
domain, CD-target, manufacturing). For bispecifics: format (IgG-like, BiTE,
DART). For gene therapy: vector + payload. Cross-link to related AACR
mechanism sessions.>

## Discussant takeaway

<Named discussant + key framing once known. ASH discussant identity is itself
a signal — senior figures in the relevant disease group set the post-meeting
narrative.>

## Practice-changing?

<Yes / no / pending, with rationale: NCCN guideline implications, FDA filing path,
unmet need, prior SOC. For non-malignant heme: NCCN-equivalent ASH guideline path.>

## Cross-links

- **AACR 2026:** <related mechanism / poster / session, if applicable>
- **AACR 2025:** <prior-year mechanism work>
- **ASCO 2026:** <heme readout earlier in the year, if applicable>
- **EHA 2026:** <mid-year European readout, if applicable>
- **ESMO 2026:** <if heme readout was presented there>
- **Other ASH 2026 trials:** <same class, same disease>
- **JPM 2026 / 2027:** <sponsor presentation / deal>

## Sources

- ASH abstract (Blood supplement): <URL or "pending Nov 4 release">
- Company press release: <URL>
- Trade-press recap: <OncLive / ASH Clinical News / Healio / ASCO Post URL>
- ClinicalTrials.gov: <NCT URL>

Master trial index (pre-meeting watch list)

Pre-meeting shortlist for stub creation. All entries below are pre-abstract-release, sourced from company pipelines + AACR 2026 mechanism sessions + EHA 2025 / ASH 2025 prior-year readouts + analyst preview pieces — to be reconciled with the Nov 4, 2026 abstract drop and the late-November LBA release. Result column entries marked italic are speculative / not yet disclosed.

Lymphoma — DLBCL + bispecifics

Trial Sponsor Indication Phase Endpoint Status (pre-abstract-release)
EPCORE NHL-2 / NHL-3 follow-up Genmab / AbbVie r/r DLBCL + 1L combinations 1b/2 / 3 PFS / CR / durability 3+ yr durability of epco mono; 1L combination signal
GO29781 / glofit + Pola-R-CHP Roche 1L DLBCL high-IPI 3 PFS / EFS Topline tracking; possible practice-changing
MajesTEC analog in DLBCL various r/r DLBCL post-CAR-T 2 ORR / CR Sequencing question — bispecific after CAR-T failure
frontMIND long-term follow-up Incyte / MorphoSys 1L DLBCL high-IPI (tafa+lena+R-CHOP) 3 OS / PFS update ASCO 2026 LBA7000 PFS+; ASH update expected
CD20×CD3 head-to-head registry data multi-sponsor r/r DLBCL real-world obs OS / ORR by class CIBMTR + ASH-flow registries

Lymphoma — CLL + indolent

Trial Sponsor Indication Phase Endpoint Status
BRUIN CLL-321 / pirtobrutinib Lilly covalent-BTKi-resistant CLL 3 PFS Pivotal update; possibly Plenary candidate
TRANSCEND CLL 004 follow-up BMS r/r CLL liso-cel 1/2 DOR / OS 2-3 yr durability
Venetoclax fixed-duration combos AbbVie frontline CLL 3 MRD-neg / PFS MAJIC, CLL17, others

Myeloma — CAR-T + bispecifics

Trial Sponsor Indication Phase Endpoint Status
CARTITUDE-5 / -6 cilta-cel J&J / Legend NDMM / 1L MM 3 PFS / MRD Pivotal frontline data expected
KarMMa-9 ide-cel BMS / 2seventy NDMM 3 PFS Frontline ide-cel pivot
MajesTEC-3 / -5 teclistamab J&J r/r MM + 1L combos 3 PFS ASCO 2026 follow-up; ASH long-term
MonumenTAL-3 talquetamab J&J r/r MM 1–3L 3 PFS Pivotal
RedirecTT-1 / -2 J&J EMD MM dual bispecific 1b/2 ORR Dual bispecific (BCMA + GPRC5D)
Allogeneic BCMA CAR-T Allogene / Caribou / others r/r MM 1 safety + ORR Class watch

Acute leukemias — AML + ALL

Trial Sponsor Indication Phase Endpoint Status
Revumenib AUGMENT-101 follow-up + combos Syndax r/r KMT2A-r / NPM1-mut AML 1/2 + combos CR / MRD Post-approval real-world + combos with ven/aza
Ziftomenib KOMET-001 / -007 / -008 Kura r/r NPM1-mut AML + frontline combos 2 / 3 CR / OS Post-approval + frontline pivot
Venetoclax maintenance AbbVie post-induction AML 3 RFS / OS VIALE-M, others
FLT3 inhibitors evolution various FLT3-mut AML 3 OS Gilteritinib, quizartinib follow-up; new TKIs
Frontline IDH inhibitors Servier / others IDH1/2-mut AML 3 EFS / OS Ivosidenib, enasidenib, olutasidenib frontline
CD19 / CD22 CAR-T in ALL Kite / Novartis / academic r/r B-ALL 3 + registry EFS / OS Adult ALL pivots + pediatric updates

MDS / MPN

Trial Sponsor Indication Phase Endpoint Status
Imetelstat post-approval Geron lower-risk MDS, transfusion-dependent reg / 4 TI rate Post-IMerge real-world
COMMANDS follow-up BMS / Acceleron lower-risk MDS ESA-naive luspatercept 3 TI rate Long-term durability
IDH inhibitors in MDS Servier IDH-mut MDS 2/3 response Frontline + post-HMA
Momelotinib / pacritinib MF GSK / Sobi myelofibrosis 3 / 4 symptom + anemia Post-approval real-world

Cell and gene therapy — durability + access

Trial Sponsor Indication Phase Endpoint Status
Exa-cel / Casgevy 3+ yr follow-up Vertex / CRISPR sickle cell + beta-thalassemia reg / 4 VOC-free / TI Post-approval durability + pediatric
Lovo-cel / Lyfgenia 3+ yr follow-up bluebird bio sickle cell reg / 4 VOC-free Post-approval; second-malignancy reporting
In-vivo base / prime editing for SCD Beam / Editas / others sickle cell (early phase) 1 safety + edit efficiency Class watch — next gen
Roctavian (val-rox) long-term BioMarin hemophilia A reg / 4 FVIII expression curve 2–4 yr durability
Hemgenix (etranadez) long-term CSL hemophilia B reg / 4 FIX expression curve 2–4 yr durability
CAR-T 5-yr durability (axi-cel, liso-cel, cilta-cel, ide-cel) Kite / BMS / J&J r/r LBCL + MM reg / 4 DOR / PFS / SPM The "CAR-T tail" — long-term curves + second-primary-malignancy

Non-malignant heme

Trial Sponsor Indication Phase Endpoint Status
Mim8 / next-gen FVIIIa-mimetic Novo Nordisk hemophilia A (with / without inhibitors) 3 bleed rate Post-FRONTIER pivot data
Concizumab / fitusiran follow-up Novo / Sanofi hemophilia A/B with inhibitors 3 bleed rate Real-world + long-term
TTP / iTTP cap / rituximab combos Sanofi / academic iTTP 3 / registry exacerbation rate Caplacizumab follow-up
Aplastic anemia frontline horse-ATG + eltrombopag NIH / academic severe AA 3 response Long-term + transplant comparison
PNH C5 vs C3 inhibitor head-to-heads Alexion / Novartis / Apellis PNH 3 hemoglobin / TI Pegcetacoplan, iptacopan, danicopan combos

Cross-cutting themes (for themes.md)

To synthesize across trials/ once populated:

  1. The "CAR-T tail" hardens. 5-yr durability curves for axi-cel, liso-cel, cilta-cel, ide-cel; SPM signal in FDA reporting; real-world vs pivotal-trial gap; sequencing after CAR-T failure.
  2. Bispecifics + CAR-T compete and combine. DLBCL: bispecific-after-CAR-T as standard salvage. MM: bispecific-after-CAR-T vs CAR-T-after-bispecific sequencing data. Class read-through to solid-tumor T-cell engagers (DLL3, B7-H3 — cross-link to lung / SCLC at ASCO).
  3. Menin / IDH / FLT3 mature in AML. Revumenib and ziftomenib post-approval; combinations with ven/aza, FLT3, IDH; frontline pivots beginning. Cross-link to AACR 2026 menin / leukemia mechanism sessions.
  4. Gene therapy for SCD — durability + access. Casgevy / Lyfgenia 3+ yr data; pediatric pivots; in-vivo next-gen approaches; payer access bottlenecks become the practical-care narrative.
  5. Hemophilia gene therapy — long-term FVIII / FIX expression decay. Roctavian and Hemgenix 2–4 yr curves define the durability ceiling; non-factor competitor data (Mim8, fitusiran) frame the alternative.
  6. MDS / lower-risk MDS becomes a structured space. Imetelstat + luspatercept + IDH inhibitors carve up frontline; IPSS-M-guided transplant decisions mature.
  7. AACR ↔ ASH mechanism-to-clinic continuity. Each ASH practice-changing trial traces to a 1–3 year prior AACR mechanism session (menin biology, CAR-T construct engineering, bispecific format, base-editing platform). Map the lineage in themes.md.