Skip to main content

Table 1 Common dimensions in intervention ensembles

From: A theoretical framework for early human studies: uncertainty, intervention ensembles, and boundaries

 

Examples

Cetuximab

Belimumab

Gene transfer for AID-SCID

Treatment dimension

 

Dose

mg/kg; cells; vector particles…

250 mg/m2

10 mg/kg

≥8 × 10^6 cells

Schedule

Daily; 4× weekly w/2 wk holidays…

Weekly until disease progression

3× @ 2-wk intervals; 4-wk intervals after

 

Administration/target

Infusion; oral; intratumoral…

Intravenous infusion

Intravenous infusion

Intravenous infusion

Co-intervention

Radiotherapy; immunosuppresion…

 

Standard of care

Non-myeloablative conditioning

Risk mitigation

Cardiac monitoring; liver enzymes…

Serum electrolytes monitoring

Monitor patients for hypersensitivity

 

Timing delivery

Symptom onset; 12 h after event…

After irinotecan or oxaliplatin failure

 

3 weeks after stopping PEG-ADA

Population dimensions

Diagnostic criteria

Marker positivity; diagnostic score…

KRAS mutation in codon 12 or 13

α-nuclear Ab titer ≥ 1:80 and/or α-dsDNA

 

Contraindications

Concurrent infection; clothing disorder…

 

Prior anaphylaxis to belimumab

Neutralizing Abs to vector (AAV8)

Indications

Disease; injury; at-risk population…

Metastatic colorectal cancer

Active systemic lupus erythematosus (SLE)

ADA-SCID

Age

 

Adults

Non-geriatric adults

Children

Outcome dimensions

Endpoint

Change on scale; time to event…

Survival

SLE responder index

Immune system reconstitution

Duration

Short term; ‘long term’ remission…

 

1 year

Permanent