Table 2.

Select advances in cellular therapies in MF/SS

ProductTargetProduct detailsORRSafety
CTX13042  CD70 Allogeneic, CRISPR/Cas9 gene-edited anti-CD70 CAR T cell ORR: 70% (7/10 at DL ≥3)
▪ PTCL: 80% (4/5 at DL ≥3)
▪ CTCL: 60% (3/5 at DL ≥3) 
CRS: 80%
▪ Gr 1-2: 80%
▪ Gr ≥3: 0%
ICANS:
▪ Gr 1-2: 30%
▪ Gr ≥3: 0% 
CD5.CAR T-cell43  CD5 Autologous second- generation CD5.CAR T-cell with CD28 costimulatory domain, non–gene edited ORR: 44% (4/9 across all DL)
▪ PTCL: 57% (4/7)
▪ CTCL: 0% (0/2) 
CRS: 44%
▪ Gr 1-2: 44%
▪ Gr ≥3: 0%
Neurotoxicity: 1 grade 2 neurotoxicity event that resolved with supportive care
Other: severe lymphopenia (<200/µL) in 8/9 patients, median duration 16 days (range 8-27) 
AFM13 plus NK cells43  CD30/CD16A bispecific First-in-class bispecific combined with preactivated, expanded cord blood-derived NK cells Ongoing phase 2 (NCT05883449, for CHL and CD30+ PTCL) IRR with AFM13 in ~7% (all ≤ Gr 2), no CRS, ICANS, or GVHD in prior trial (NCT04074746) 
5F11-28Z44  CD30 Anti-CD30 CAR with CD28 costimulatory domain ORR: 43% (trial included 20 patients with CHL, 1 patient with ALCL; NCT03049449) Trial stopped early for toxicity, including prolonged cytopenia with life-threatening sepsis, prolonged severe rashes 
ProductTargetProduct detailsORRSafety
CTX13042  CD70 Allogeneic, CRISPR/Cas9 gene-edited anti-CD70 CAR T cell ORR: 70% (7/10 at DL ≥3)
▪ PTCL: 80% (4/5 at DL ≥3)
▪ CTCL: 60% (3/5 at DL ≥3) 
CRS: 80%
▪ Gr 1-2: 80%
▪ Gr ≥3: 0%
ICANS:
▪ Gr 1-2: 30%
▪ Gr ≥3: 0% 
CD5.CAR T-cell43  CD5 Autologous second- generation CD5.CAR T-cell with CD28 costimulatory domain, non–gene edited ORR: 44% (4/9 across all DL)
▪ PTCL: 57% (4/7)
▪ CTCL: 0% (0/2) 
CRS: 44%
▪ Gr 1-2: 44%
▪ Gr ≥3: 0%
Neurotoxicity: 1 grade 2 neurotoxicity event that resolved with supportive care
Other: severe lymphopenia (<200/µL) in 8/9 patients, median duration 16 days (range 8-27) 
AFM13 plus NK cells43  CD30/CD16A bispecific First-in-class bispecific combined with preactivated, expanded cord blood-derived NK cells Ongoing phase 2 (NCT05883449, for CHL and CD30+ PTCL) IRR with AFM13 in ~7% (all ≤ Gr 2), no CRS, ICANS, or GVHD in prior trial (NCT04074746) 
5F11-28Z44  CD30 Anti-CD30 CAR with CD28 costimulatory domain ORR: 43% (trial included 20 patients with CHL, 1 patient with ALCL; NCT03049449) Trial stopped early for toxicity, including prolonged cytopenia with life-threatening sepsis, prolonged severe rashes 

ALCL, anaplastic large cell lymphoma; CAR, chimeric antigen receptor; CHL, classical Hodgkin lymphoma; CRS, cytokine release syndrome; Gr, grade; GVHD, graft-versus-host-disease; ICANS, immune effector cell-associated neurotoxicity syndrome; IRR, infusion-related reaction; NK, natural killer; PTCL, peripheral T-cell lymphoma.

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