Trials — SITC 2026

One of two primary artifacts in this vault: one Markdown file per drug or cell-therapy readout. SITC 2026 reads out a heavy block of early- and mid-phase IO trials — CAR-T (autologous + allogeneic + in vivo), TIL, TCR-T, NK-cell, bispecifics, neoantigen vaccines, and checkpoint-resistance combos. Each gets a trials/<slug>.md entry. The methods / immune-profiling side lives in tools/.

Status: Template + master index. Per-trial pages will be populated as the SITC program is announced (program-at-a-glance typically posts in September; full abstracts via JITC supplement in October; presentation embargoes lift on the morning of the talk). Pre-meeting stubs flagged *expected, subject to embargo* are sourced from sponsor toplines, JPM 2026 / AACR 2026 / ASCO 2026 framing, and analyst preview pieces; numbers can shift on the actual abstract reveal.

Per-trial template

Each trial file (e.g., obe-cel-r2-all.md, bnt122-melanoma.md) follows this schema. Copy and fill:

# <Trial acronym / name> — <Drug regimen / cell-therapy product, indication, line>

> **Abstract:** <JITC abstract #, e.g., 102> · **Session:** <session name, date, time MST, room> · **Embargo:** <presentation date>

## At a glance

- **Sponsor:** <pharma / academic / cooperative group>
- **PI / presenter:** <name, institution>
- **NCT ID:** <NCTxxxxxxxx>
- **Modality:** <autologous CAR-T / allogeneic CAR-T / in vivo CAR-T / TIL / TCR-T / NK cell / bispecific / mRNA neoantigen vaccine / peptide vaccine / checkpoint combo / ADC + IO / immunocytokine>
- **Target / construct:** <CD19 / BCMA / GPRC5D / Claudin18.2 / HLA-A*02 NY-ESO-1 / personalized neoantigen / PD-1×VEGF / etc.>
- **Phase:** <1 / 1b / 2 / 1-2 / 2-3>
- **Design:** <dose-escalation / dose-expansion / randomized / single-arm / basket / platform>
- **N:** <enrolled / treated / analyzed>
- **Primary endpoint(s):** <ORR / CR / PFS / OS / DLT / safety / immunogenicity>
- **Indication:** <tumor type, subtype, biomarker selection (HLA, antigen expression, MSI, TMB)>
- **Line:** <neoadjuvant / adjuvant / 1L / 2L+ / R/R / heavily pretreated>

## Headline result

<One paragraph. ORR, CR rate, duration of response, safety profile if known.
If pre-embargo, mark `*expected per <company> topline <date>*` or
`*pre-embargo per <analyst source>*`.>

## Mechanism / class

<Modality detail: construct architecture for cell therapies (CAR design, costim
domain, edits); target rationale; manufacturing / vein-to-vein time;
neoantigen-selection pipeline for vaccines. Cross-link to related AACR
mechanism sessions where the biology was presented.>

## Biomarker / correlative readout

<This is the SITC-specific field. What immune-profiling assay anchored the
trial? Multiplex IF? scRNA-seq of TILs? TCR repertoire? ctDNA-MRD? Cross-link
to the corresponding `tools/<assay>.md` entry. Many SITC trials present
biomarker correlatives in the same talk as the efficacy numbers.>

## Discussant / session framing

<Session chair + co-presenters, if a themed concurrent session. SITC doesn't
have ASCO-style discussants, but session co-programming is itself a signal.>

## Practice-changing / class-defining?

<Yes / no / pending, with rationale: first-in-class signal, dose decision for
pivotal, BLA path, unmet need, competitive context vs prior cell therapies
or checkpoint baselines.>

## Cross-links

- **AACR 2026:** <related mechanism / TME / biology session>
- **AACR 2025:** <prior-year construct / target work>
- **ASCO 2026:** <if a Ph3 ASCO readout used the same construct / target>
- **JPM 2026:** <sponsor presentation / cell-therapy strategy slide / deal>
- **SITC 2026 tools:** <multiplex IF / TCR / spatial assay used for correlative>
- **Other SITC 2026 trials:** <same modality / target / sponsor>

## Sources

- JITC abstract supplement: <DOI URL or "pending JITC publication">
- Company press release: <URL>
- Trade-press recap: <OncLive / ACIR / Targeted Oncology URL>
- ClinicalTrials.gov: <NCT URL>

Master trial index

Pre-meeting shortlist — to be expanded as the SITC 2026 program-at-a-glance posts (~Sep 2026). All entries below are anticipated / speculative, sourced from sponsor pipelines, AACR 2026 echo, JPM 2026 strategy slides, and SITC 2025 program shape. Treat every row as *expected, subject to embargo* until JITC publishes.

Modality	Sponsor / lab	Indication	Phase	Target / construct	Anticipated readout	Why it's on the list
In vivo CAR-T	Capstan / AstraZeneca	Autoimmune + onc	1	CD19 lipid-nanoparticle	First-in-human safety + B-cell depletion kinetics	The in vivo CAR-T thesis — one of SITC 2026's likely headline tracks
Allogeneic CAR-T	Allogene / Caribou / Cellectis	R/R LBCL / MM	1/2	CD19 / BCMA, gene-edited	Updated CR durability, donor-derived persistence	Allogeneic remains the off-the-shelf bet
Solid-tumor CAR-T	various academic + biotech	GBM, mesothelioma, colorectal	1	CLDN18.2, GPC3, GD2, mesothelin	Dose-escalation safety + early response	Solid-tumor CAR-T inflection thesis
TIL therapy	Iovance	2L+ melanoma, NSCLC, cervical	2/3	TIL (Amtagvi follow-on cohorts)	Real-world durability + NSCLC update	Post-Amtagvi-approval data
TCR-T	Adaptimmune / TScan / Immatics	Synovial sarcoma, MAGE-A4+ solid	2	HLA-A*02 MAGE-A4 / NY-ESO-1	Durability beyond afami-cel approval	TCR-T solid-tumor thesis
Bispecific (T-cell engager)	Janssen / Pfizer / Roche / IGM	MM, DLBCL, solid (incl Claudin18.2)	1/2	BCMA×CD3, CD20×CD3, CLDN18.2×CD3	Updated ORR + step-up dosing safety	Bispecific class durability in heme + GI
PD-1 × VEGF bispecific	Summit / Akeso / BMS / AbbVie	NSCLC, CRC, HCC	1b/2	PD-1×VEGF (ivonescimab and follow-ons)	Mechanism-of-action correlative data	Class follow-through from HARMONi-6 ASCO Plenary
NK-engager	Affimed / Sanofi / Cytovia	R/R LBCL, AML	1/2	CD16A×CD30, CD16A×BCMA	Updated CR + persistence	NK platform reset post-Sanofi deal
Personalized mRNA neoantigen vaccine	Moderna / Merck	Adjuvant melanoma, NSCLC, RCC	2/3	mRNA-4157 (V940) + pembro	Updated RFS, immunogenicity correlative	The neoantigen-vaccine signal — top of mind for Wu Smalley lecture
Personalized mRNA neoantigen vaccine	BioNTech / Genentech	Pancreatic adjuvant, CRC	1/2	BNT122 (autogene cevumeran) + chemo / atezo	Updated RFS, T-cell expansion	The DFCI / MSK pancreatic vaccine thread
Shared-antigen peptide vaccine	Gritstone / Nouscom / EpiVax	Adjuvant CRC, MSS CRC, lung	1/2	KRAS-mut shared neoantigens	T-cell response + recurrence signal	Shared-neoantigen platform comparison
Checkpoint × LAG-3	BMS / Regeneron / Macrogenics	Melanoma 1L combos	2/3	Relatlimab + nivo follow-ons; novel LAG-3	Updated mPFS, biomarker-defined subsets	LAG-3 class status
Checkpoint × TIGIT	Roche / iTeos / Gilead	NSCLC, GI subsets	2	Tiragolumab / EOS-448 + checkpoint	Subset rescue post-Skyscraper failure	TIGIT class status
Microbiome × IO	Vedanta / Seres / Finch / academic	Melanoma + RCC checkpoint-refractory	1/2	Defined consortium, FMT	Response rate after FMT or VE303-class	Microbiome × IO maturation (Wargo continued)
ADC × IO combo	Pfizer / Gilead / Daiichi	mUC, TNBC, HER2+ GC	1b/2	EV+pembro, Trop2-ADC+IO, T-DXd+IO	Safety + ORR uplift	ADC×IO combo durability
Immunocytokine	Philogen / Mural / Asher Bio	Melanoma, RCC, NSCLC	1/2	IL-2v-targeted, IL-12-tumor-localized	Tolerability + intratumoral T-cell expansion	Cytokine-engineering revival

Additional candidates to stub once the program lists land:

• CAR-NK updates (NKARTA, ImmunityBio, Wugen, Affimed)
• Engineered Tregs (early-phase IO and autoimmune crossover)
• In vivo gene-edited cell therapy — beyond Capstan; competitive set
• Checkpoint combos in MSS CRC — long-standing unmet need cohort
• Brain-tumor IO — GBM cell therapy, neoadjuvant IO in glioma
• HPV-driven cancer vaccines + checkpoint — head & neck, cervical

Cross-cutting themes (for post-meeting themes.md)

To synthesize across trials/ once populated:

1. Solid-tumor CAR-T inflection. Whether GBM, GI, and mesothelioma CAR-T cohorts cross the response threshold that justifies pivotal trials.
2. In vivo CAR-T arrives. Capstan / Umoja / Orna / Outpace LNP-delivered constructs — first-in-human safety + B-cell kinetics will define a new modality.
3. Neoantigen-vaccine signal hardens (or doesn't). Moderna mRNA-4157 RFS update + BioNTech BNT122 pancreatic + Gritstone shared-antigen CRC. Wu Smalley lecture frames the field.
4. Bispecific durability and resistance. BCMA × CD3 and CD20 × CD3 long-term follow-up — antigen escape, T-cell exhaustion, sequencing vs CAR-T.
5. LAG-3 / TIGIT class status. Post-Skyscraper TIGIT cohorts and LAG-3 expansion data — which checkpoint partner survives.
6. Microbiome × IO matures. Defined-consortium and FMT data in checkpoint-refractory melanoma + RCC, the through-line from Wargo's SITC 2025 keynote.
7. PD-1 × VEGF bispecific class. Mechanism-of-action correlatives following HARMONi-6 OS readout at ASCO Plenary.