Study · SPEARHEAD-3

SPEARHEAD-3: afamitresgene autoleucel paediatric basket

recruiting NCT05642455

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

Phase I/II MAGE-A4-positive synovial sarcoma, MPNST, neuroblastoma, osteosarcoma (ages 2-17) Sponsor US WorldMeds (ex-Adaptimmune) FPI 2023-09-01

Study design

Design: Paediatric basket (PREA-required) open-label
Primary endpoint: Incidence, severity and duration of TEAEs; DLTs; RCL; insertional oncogenesis
Enrollment: 3 of 20 target
Provenance: Sarcoma: 100 assets in the clinic, and who to call

UpstreamClinicalTrials.gov NCT05642455

Extracted 2026-10-03

Open source record

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.

Decisions awaiting you 4

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

critical adverse_event · assess_serious_event

SAE — SAE Narrative Subject: NCT05642455-P02 Age/Sex: 15-year-old female Study arm: [PENDING — human input] Event: Adverse event, not yet coded (System Organ Class: [PENDING — human input]) Seriousness: Serious Severity grade: Grade 3 Onset date: [PENDING — human input] Outcome: [PENDING — human input] Resolution date: [PENDING — human input] Action taken: [PENDING — human input] Source information: Participant-reported via Luna chat: "I've had a high fever since last night." This is a solicited symptom report and requires clinical characterization. Causality ass [narrative drafted by claude-sonnet-5; verify against source fields]

critical adverse_event · assess_serious_event

SAE — SAE Narrative Subject: NCT05642455-P02 Age/Sex: 15-year-old female Treatment Arm: [PENDING — human input] Event Description: Adverse event, not yet coded (System Organ Class: [PENDING — human input]). The event was reported as serious and graded as Grade 3 in severity. Source of Report: Participant-reported via Luna chat: "high fever." This is a solicited symptom report and requires clinical characterization. Onset Date: [PENDING — human input] Outcome: [PENDING — human input] [narrative drafted by claude-sonnet-5; verify against source fields]

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

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Protocol versions 0

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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.

Site	Country	Principal investigator	Site status	Contract	Participants	Risk
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

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Supply forecasts 0

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Regulatory submissions 0

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Study documents 0 files

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