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Atlas/Cell therapy/Ryoncil/First dose

Ryoncil: how was the first human dose set?

remestemcel-L · Allogeneic BM-MSC
Check my plan vs. these
First-in-human starting dose
No formal dose-finding; 2x10^6 cells/kg clinical dose from earlier clinical/expanded access experience, not nonclinically derived
“No formal pharmacokinetic, clinical dose finding, or dose regimen optimization studies have been performed during the development of RYONCIL for treatment of aGvHD in pediatrics.”
✓ VerifiedFDA summary basis for approval, p. 13Source ↗
NOAEL / key findings
No NOAEL; rat mortality at >=10-15x10^6 cells/kg with pulmonary thrombi; baboon 5x10^6 cells/kg no toxicity
“Dose levels of 15x106 cells/kg and higher resulted in increased mortality shortly after dosing, associated with shallowed breathing, impaired righting reflex, and pale discolored skin.”
✓ 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

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

Breyanzi

lisocabtagene maraleucel · 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 →