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Atlas/Cell therapy/Breyanzi/First dose

Breyanzi: how was the first human dose set?

lisocabtagene maraleucel · CD19 CAR-T
Check my plan vs. these
First-in-human starting dose
Not stated in public reviews
NOAEL / key findings
No NOAEL; long-term safety in animals limited; tissue cross-reactivity showed off-target recognition of low concern
“Animal studies to assess the long-term safety of JCAR017 were limited because the JCAR017 does not survive in immunocompetent rodents and induces graft-versus-host disease in immunocompromised mice.”
✓ VerifiedFDA pharmacology/toxicology review, p. 2Source ↗

Same question, other cell therapies

Abecma

idecabtagene vicleucel · BCMA CAR-T
Not explicitly stated; mouse MED 6.16x10^5 CAR+ cells corresponds to HED 2.05x10^8 CAR+ T cells (100 kg)

ChondroCelect

characterised viable autologous cartilage cells · Autologous chondrocytes
Clinical 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 islets
No nonclinical basis; target 10,000 EIN/kg from prior Edmonton Protocol clinical experience

Ryoncil

remestemcel-L · Allogeneic BM-MSC
No 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 + Tcon
No nonclinical basis; Phase 1/2 clinical safety data with a similar product supported the Phase 1b dose levels

Alofisel

darvadstrocel · Allogeneic adipose MSC
Not stated in public reviews

Amtagvi

lifileucel · TIL therapy
Not stated in public reviews

Aucatzyl

obecabtagene autoleucel · CD19 CAR-T
Not stated in public reviews

Carvykti

ciltacabtagene autoleucel · BCMA CAR-T
Not stated in public reviews

Ebvallo

tabelecleucel · EBV-specific allogeneic T cells
Not 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 + fibroblasts
Not stated in public reviews

Holoclar

autologous corneal epithelial cells containing limbal stem cells · Autologous limbal stem cells
Not stated in public reviews

Kymriah

tisagenlecleucel · CD19 CAR-T
Not stated in public reviews

Laviv

azficel-T · Autologous fibroblasts
Not stated in public reviews

MACI

autologous cultured chondrocytes on porcine collagen membrane · Autologous chondrocytes
Not stated in public reviews

Omisirge

omidubicel · Expanded cord blood HPC
Not stated in public reviews

Provenge

sipuleucel-T · PAP-GM-CSF (autologous APC)
Not stated in public reviews

Rethymic

allogeneic processed thymus tissue · Allogeneic thymus tissue
Not stated in public reviews

Spherox

spheroids of autologous matrix-associated chondrocytes · Autologous chondrocyte spheroids
Not stated in public reviews

StrataGraft

allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen · Allogeneic keratinocytes + fibroblasts
Not stated in public reviews

Tecartus

brexucabtagene autoleucel · CD19 CAR-T
Not stated in public reviews

Tecelra

afamitresgene autoleucel · MAGE-A4 TCR-T
Not stated in public reviews

Yescarta

axicabtagene ciloleucel · CD19 CAR-T
Not stated in public reviews

Zalmoxis

allogeneic T cells modified with HSV-TK / dLNGFR (nalotimagene carmaleucel) · HSV-TK suicide-gene T cells
Not stated in public reviews

Zemcelpro

dorocubicel · UM171-expanded cord blood CD34+
Not stated in public reviews

Summary across all 27 cell therapies →