Abecma
idecabtagene vicleucel · BCMA CAR-TNot explicitly stated; mouse MED 6.16x10^5 CAR+ cells corresponds to HED 2.05x10^8 CAR+ T cells (100 kg)
Laviv: how was the first human dose set?
azficel-T · Autologous fibroblasts
First-in-human starting dose
Not stated in public reviews
Why it's blank
The public FDA and EMA reviews of Laviv don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.
How it's usually set for cell therapies
FDA expects preclinical proof-of-concept and toxicology studies to identify active dose levels and support the choice of starting dose and escalation. The 2013 guidance gives no numeric formula or scaling rule for the starting dose.
“Selection of potential starting dose level, dose-escalation schedule, and dosing regimen for clinical trials.”
✓ VerifiedFDA 2013: Preclinical Assessment of Investigational Cellular and Gene Therapy…, p. 7Source ↗
NOAEL / key findings
Not stated in public reviews
Not reported in the public reviews. Reviewers summarise selectively, so this usually means it wasn't discussed publicly, not that it wasn't studied.
Same question, other cell therapies
ChondroCelect
characterised viable autologous cartilage cells · Autologous chondrocytesClinical dose 0.8-1 x10^6 cells/cm2 based on animal studies, literature and ACI experience (not a formal FIH calculation)
Lantidra
donislecel · Allogeneic pancreatic isletsNo nonclinical basis; target 10,000 EIN/kg from prior Edmonton Protocol clinical experience
Ryoncil
remestemcel-L · Allogeneic BM-MSCNo formal dose-finding; 2x10^6 cells/kg clinical dose from earlier clinical/expanded access experience, not nonclinically derived
Tregzi
allogeneic Treg immunotherapy with HSPC and T cells (Orca-T) · Allogeneic Treg + HSPC + TconNo nonclinical basis; Phase 1/2 clinical safety data with a similar product supported the Phase 1b dose levels
Alofisel
darvadstrocel · Allogeneic adipose MSCNot stated in public reviews
Amtagvi
lifileucel · TIL therapyNot stated in public reviews
Aucatzyl
obecabtagene autoleucel · CD19 CAR-TNot stated in public reviews
Breyanzi
lisocabtagene maraleucel · CD19 CAR-TNot stated in public reviews
Carvykti
ciltacabtagene autoleucel · BCMA CAR-TNot stated in public reviews
Ebvallo
tabelecleucel · EBV-specific allogeneic T cellsNot stated in public reviews
Encelto
revakinagene taroretcel · CNTF (encapsulated RPE cell implant)Not stated in public reviews
Gintuit
allogeneic cultured keratinocytes and fibroblasts in bovine collagen · Allogeneic keratinocytes + fibroblastsNot stated in public reviews
Holoclar
autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cellsNot stated in public reviews
Kymriah
tisagenlecleucel · CD19 CAR-TNot stated in public reviews
MACI
autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytesNot stated in public reviews
Omisirge
omidubicel · Expanded cord blood HPCNot stated in public reviews
Provenge
sipuleucel-T · PAP-GM-CSF (autologous APC)Not stated in public reviews
Rethymic
allogeneic processed thymus tissue · Allogeneic thymus tissueNot stated in public reviews
Spherox
spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroidsNot stated in public reviews
StrataGraft
allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblastsNot stated in public reviews
Tecartus
brexucabtagene autoleucel · CD19 CAR-TNot stated in public reviews
Tecelra
afamitresgene autoleucel · MAGE-A4 TCR-TNot stated in public reviews
Yescarta
axicabtagene ciloleucel · CD19 CAR-TNot stated in public reviews
Zalmoxis
allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cellsNot stated in public reviews
Zemcelpro
dorocubicel · UM171-expanded cord blood CD34+Not stated in public reviews