anitocabtagene autoleucel (CART-ddBCMA)

Ide-cel and Cilta-cel are CAR-T cells directed against BCMA, having received FDA approval for RRMM based on the Phase 2 KarMMa and CARTITUDE trials, respectively...Additional anti-BCMA targeted medicines, including LCAR-B38M, completely humanized CAR-T (FHVH-T), P-BCMA-ALLO-1, ALLO-715, and anti-BCMA CAR-NK, provide promising treatment options. Moreover, the anti-CD19 Fast-CAR, designed to shorten production time, and PHE885, which possesses in-vivo proliferation capability, are regarded as very efficacious...The development of academic CAR-Ts such as ARI0002h, HBI0101, eque-cel, zevor-cel, anito-cel, and Sleeping Beauty (utilizing a non-viral vector) have importance due to their accessibility and cost-effectiveness...To overcome these issues, strategies are being implemented, including combination therapy, the incorporation of gamma-secretase inhibitors etc. In conclusion, CAR-T treatments have evolved into an effective therapy modality being anticipated to be utilized in earlier phases in the future. Gene editing (CRISPR) method contributes to the future perspective.

P1, N=30, Recruiting, Arcellx, Inc. | Initiation date: Jan 2025 --> Apr 2025

P2, N=30, Recruiting, PETHEMA Foundation | Not yet recruiting --> Recruiting

P2, N=129, Active, not recruiting, Kite, A Gilead Company | Recruiting --> Active, not recruiting | Trial completion date: May 2025 --> Dec 2026 | Trial primary completion date: May 2024 --> Dec 2026

P2, N=30, Not yet recruiting, PETHEMA Foundation

P1, N=30, Recruiting, Arcellx, Inc. | Not yet recruiting --> Recruiting

P=N/A, N=1000, Enrolling by invitation, Kite, A Gilead Company | N=700 --> 1000

P1, N=30, Not yet recruiting, Arcellx, Inc.

P3, N=450, Recruiting, Kite, A Gilead Company | Not yet recruiting --> Recruiting

P3, N=450, Not yet recruiting, Kite, A Gilead Company

Briefly, pts with RRMM who have received ≥3 prior lines of therapy were enrolled & received a single infusion of CART-ddBCMA following lymphodepletion chemotherapy (fludarabine: 30 mg/m2/d & cyclophosphamide: 300 mg/m2/d daily for 3 days). Adverse events with CART-ddBCMA, including CRS & ICANS, were manageable & no off-tumor tissue-targeted toxicity, delayed neurotoxicity, or Parkinsonian-like events were observed in the entire cohort at the time of data-cut. Ongoing efficacy results are encouraging, with 100% ORR, including 35 (92%) response of VGPR or better & 29 (76%) with CR/sCR. More importantly, clinical responses were durable with an overall estimated 18-mo PFS rate of 67% with comparable clinical responses seen in 'high-risk' patients known to have poor prognosis.

P1, N=65, Recruiting, Arcellx, Inc. | Trial primary completion date: Aug 2022 --> Aug 2024