GalenOps prod · 0.1.0

Study · SPEARHEAD-1

SPEARHEAD-1: afamitresgene autoleucel in advanced synovial sarcoma and MRCLS

active_not_recruiting NCT04044768

Afamitresgene autoleucel (afami-cel, Tecelra), autologous MAGE-A4 TCR-T

Phase II Advanced synovial sarcoma, myxoid/round cell liposarcoma Sponsor US WorldMeds (ex-Adaptimmune) FPI 2019-08-13

Study design

Design
Registrational and confirmatory, cohorts 1-3 open-label
Primary endpoint
ORR by independent review (RECIST 1.1)
Enrollment
3 of 52 target
Provenance

Sarcoma: 100 assets in the clinic, and who to call

Agentic orchestration

Runs all 13 lifecycle agents below in order; each records what it did, the evidence it used, and escalates to a human only on exception.

Horizon 3

Idle — the checklist below shows the last recorded state of every step.

Study lifecycle checklist 0 / 13

13 steps in trial order. Expand a step to see exactly what the agent did, the evidence it computed, and what it produced; steps needing a decision link to the review queue.

Re-assess feasibility with new inputs

Decisions awaiting you 3

Every escalation the agents raised on this study, decided here exactly as on the dashboard. Open an item's details before deciding; a note goes on the audit trail.

deciding as portal.reviewer
medium adverse_event · assess_serious_event

Non-serious event needing physician assessment — Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)

medium adverse_event · assess_serious_event

Non-serious event needing physician assessment — Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)

medium adverse_event · assess_serious_event

Non-serious event needing physician assessment — Grade 1 adverse event, not serious, causality not assessed — investigator assessment required, expectedness undetermined — event not yet coded — under safety physician review (triage only; causality and closure are the physician's)

Agent reasoning trail 0 runs

Explainable, traceable, inspection-ready — every automated action records why it did what it did and the evidence it used (FDA/EMA January 2026 AI guiding principles).

No agents have run on this study yet

Run agent pipeline records every step's reasoning and evidence here.

Protocol versions 0

Every version stays on file. Read any version in full; edit the newest to save the next draft and re-run the protocol agent's SPIRIT lint on it.

No protocol yet

Run the “Protocol drafted” step to create v0.1.

Sites 0

Every site contracted for this study or with a participant on it — with this study's contract stage and enrollment. Open a site for its full monitoring picture.

SiteCountryPrincipal investigatorSite statusContractParticipantsRisk

No sites on this study yet

Sites appear once a contract goes out to them or a participant is placed there. The site activation agent proposes the first wave.

All sites

Feasibility 0

No assessment yet

Use the form above to assess a region.

Supply forecasts 0

No forecast yet

Run the supply step to size the first kit order.

Regulatory submissions 0

Nothing submitted yet

The regulatory step compiles the IND/CTA once the protocol is approved.

Study documents 0 files

Everything generated or filed for this study. Open a file to preview it as a PDF.

No documents yet

Documents appear as the protocol, TLF and CSR steps run.