Table 2 Pivotal trials of CARTs labelled for r/r MCL.
Lisocel (TRANSCEND NHL 001/MCL) [60] | ||
|---|---|---|
Study type | Phase-2 | Phase-2 |
Eligibility | r/r incl. BTKi; PS 0-1; no CNS disease; no prior alloHCT; ≤5 prior lines | ≥2 L incl. BTKi; PS 0-1 |
N | ||
# apheresed (%) | 74 | 104 |
# Treated set (%) | 68 (92%) | 83 (80%) |
Period | 2016–2019 | 2016–2022 |
Age (years; median (range)) | 65 (38–79) | 69 (36–86) |
PS > 0 (ECOG) | n.a. | 45% |
High-risk features | ||
Ki-67 ≥ 30% | 82% | 75% |
Blastoid/pleomorph. | 31% | 31% |
TP53abn | 17% | 23% |
POD24 | 49% | n.a. |
2nd CNS involvement | - | 8% |
Prior lines/median (range) | 3 (1-5) | 3 (1-11) |
Prior autoHCT | 43% | 30% |
Prior alloHCT | - | 7% |
BTKi refractory | 62% | 53% |
Holding/Bridging | BTKi/steroids | Any |
Received Bridging | 37% | 66% |
BTKi | 76% | n.a. |
Response to Bridging | low | n.a. |
Toxicity | ||
Neurotox ≥ G3 | 31% | 9% |
Late ICAHT ≥ G2 | ≥16% | 24% |
Severe infection | 32% | 15% |
ICU admission | n.a. | 7% |
Non-relapse mortality | 7.4%b | 18%a |
Best ORR/CR | 92%/68% | 87%/75% |
PFS from infusion (12mo)(median) | 62%/25mo | 53%/15mo |
OS from infusion (12mo) | 81%/47mo | 62%/18mo |
Median follow-up (months) | 68 | 24 |
