Fucaso (equecabtagene autoleucel)

In vivo, Nb17-nanoCAR-T and CT103a eradicated tumors in NSG mice. These findings demonstrate Nb17-nanoCAR-T exhibits potent anti-myeloma efficacy comparable to scFv-based CAR-T, supporting its potential as a promising therapeutic alternative.

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=40, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China

P2, N=17, Not yet recruiting, Nanjing IASO Biotechnology Co., Ltd.

P=N/A, N=1500, Recruiting, Nanjing IASO Biotechnology Co., Ltd.

P=N/A, N=6, Recruiting, Tongji Hospital

P1, N=36, Recruiting, Tongji Hospital | N=18 --> 36 | Trial completion date: May 2024 --> May 2027 | Trial primary completion date: Feb 2024 --> Feb 2027

P=N/A, N=260, Not yet recruiting, Peking University People's Hospital

Lymphodepletion was performed using Fludarabine (30 mg/m2) and cyclophosphamide (500 mg/m2) for three consecutive days. The updated data from the long-term follow-up of CT103A demonstrated a durable clinical benefit for RRMM patients, based on the sustained existence of fully human CAR-T cells. In addition, the favorable safety profile strengthens the prospect of clinical application of CT103A.

Equecabtagene autoleucel was granted conditional approval in China in June 2023 for the treatment of adults with relapsed or refractory MM (RRMM) who have progressed after ≥ 3 lines of therapy (≥ 1 proteasome inhibitor and an immunomodulator). This article summarizes the milestones in the development of equecabtagene autoleucel leading to this first approval in patients with RRMM who have progressed after multiple lines of therapy.

At a longer median follow-up of 13.8 months, CT103A achieved deep and long-lasting responses in heavily pre-treated patients with MM. Furthermore, patients with prior BCMA CAR-T cell therapy who achieved sCR had sustained sCR over 18 months. CT103A demonstrated a favorable safety profile with no new risk observed with longer follow-up.

P1, N=20, Recruiting, Chunrui Li | Not yet recruiting --> Recruiting