NCT05642455

Studies / Phase I/II

SPEARHEAD-3: afamitresgene autoleucel paediatric basket

US WorldMeds (ex-Adaptimmune) · MAGE-A4-positive synovial sarcoma, MPNST, neuroblastoma, osteosarcoma (ages 2-17)

recruiting

Sites

0

Patients

4

Target N

20

Enrolled

3

Steps done

0/13

Decisions

4

Design

Title
SPEARHEAD-3: afamitresgene autoleucel paediatric basket
Design
Paediatric basket (PREA-required)
Therapy
Afamitresgene autoleucel (afami-cel, Tecelra), autologous MAGE-A4 TCR-T
Primary endpoint
Incidence, severity and duration of TEAEs; DLTs; RCL; insertional oncogenesis

Lifecycle

0 of 13 done

Feasibility assessed

Can this study realistically enroll — sites, patients, timeline?

not started

Protocol drafted & medically reviewed

A protocol synopsis exists, has been linted against SPIRIT, and is through medical review.

not started

Sites activation-ready

Every site's contract, activation and first-patient timeline is within benchmark.

not started

Recruitment funnel and screening plan

Enrollment funnel, accrual pace and eligibility yield computed; candidates to screen proposed per site (import is human-gated).

not started

Sites risk-scored

Per-site KRIs z-scored across the study; statistical outliers get a proposed on-site visit.

not started

Data cleaned

18 edit checks swept AE, DM, SV, EX and LB; deterministic queries auto-closed.

not started

Safety reports triaged

Every reported adverse event triaged with an E2A clock; serious ones with a physician.

not started

Dropout risk scored

Active patients scored; at-risk cohort proposed for outreach.

not started

Termination risk watched

Accrual curve, literature risk profile and registry comparators surveilled; termination itself stays a human decision.

not started

Drug supply forecast

Kits required over the horizon from observed dosing, accrual and discontinuation (partner IRT).

not started

TLFs generated & validated

ICH E3 Section 14 tables from live data (disposition, demographics, exposure, AEs, Kaplan-Meier efficacy), pending double-programming validation.

not started

CSR drafted & signed off

ICH E3 clinical study report assembled from study data; medical sign-off required.

not started

TMF inspection-ready

Trial master file audited against the DIA TMF Reference Model; gaps filed as QA findings.

not started

Sites

0

No sites contracted for this study yet.

Patients

4

NCT05642455-P01

enrolled

NCT05642455-P02

enrolled

NCT05642455-P03

enrolled

NCT05642455-P04

screened

Pending decisions

4

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

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

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]

critical

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