CT103A, a novel fully human BCMA-targeting CAR-T cells, in patients with relapsed/refractory multiple myeloma: Updated results of phase 1b/2 study (FUMANBA-1).

医学 耐火材料(行星科学) 内科学 多发性骨髓瘤 来那度胺 不利影响 临床研究阶段 外科 胃肠病学 肿瘤科 毒性 天体生物学 物理
作者
Chunrui Li,Di Wang,Yong-ping Song,He Huang,Jianyong Li,Ming Sun,Jing Liu,Yujun Dong,Kai Hu,Peng Liu,Qian Zhang,Jian‐Qing Mi,Zhenyu Li,Kaiyang Ding,Aining Xu,Song-bai Cai,Jing-jing Guo,Haojun Gui,Wen Wang,Lugui Qiu
出处
期刊:Journal of Clinical Oncology [American Society of Clinical Oncology]
卷期号:41 (16_suppl): 8025-8025 被引量:9
标识
DOI:10.1200/jco.2023.41.16_suppl.8025
摘要

8025 Background: CT103A, which is designed with a fully human BCMA-specific CAR structure, has shown sustained efficacy and durable safety in heavily pretreated relapsed and refractory multiple myeloma patients. Here, we report updated efficacy and safety data of its phase 1b/2 study (FUMANBA-1) with longer duration of follow-up. Methods: FUMANBA-1 is conducted in 14 centers in China. This study enrolled RRMM patients who received ≥ 3 lines of prior therapies containing at least a proteasome inhibitor and an immunomodulatory agent and were refractory to their last line of treatment. Patients who have progressed on previous BCMA CAR-T cell therapy were also included. All patients received a single infusion of CT103A at the dose of 1.0 x 10 6 CAR-T cells/Kg. The objective is to evaluate the efficacy, safety and PK/PD of CT103A. Results: As of the September 9 th , 2022, 103 patients [53.4% male; median age 58.0 years (range 39-70)] with RRMM received CT103A (17 in phase 1b; 86 in phase 2) with a median follow-up of 13.8 months (range 0.4 to 27.2). The treated patients had received a median of 4 (range 3-23) lines of prior therapy. 101 patients were evaluable for efficacy assessment. The median time to first response was 16 days (range 11-179). A 96% ORR was observed, with 74.3% ≥ CR. Median DOR and median PFS have still not reached. The 12-month PFS rate was 78.8% (95% CI: 68.6–85.97). For patients without prior BCMA CAR-T therapy (N = 89), ORR was 98.9% with 78.7% ≥ CR. For patients without prior BCMA CAR-T therapy and received CT103A for more than 6 months as of the cutoff date (N = 81), ORR was 98.8% with 80.2% ≥ CR. For patients with prior BCMA CAR-T cell therapy, 4/5 (80%) of those who achieved sCR still sustained sCR over 18 months post infusion. Of the 101 patients, 95% achieved MRD-negativity with a median time to MRD-negative of 14 days (range 13-185), and all patients with CR/sCR were MRD-negative. Furthermore, 82.4% (95%CI 70.90-89.72%) achieved sustained MRD negativity over 12 months. Since the previous publication in 64 th ASH meeting, no new events of CRS and ICANS occurred. The most common ≥ grade 3 treatment-related AEs were still hematologic. The expansion of CT103A reached the median peak level of 87570.6 copies/μg gDNA at a median of 12 days. CT103A was still above lower limit of qualification (100 copies/μg gDNA) in 50.0% (28/56) patients at 12 months and 40.0% (4/10) patients at 24 months after infusion. In addition, only 20 of 103 patients (19.4%) with evaluable samples were detected to be positive for the anti-drug antibody. Conclusions: 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. Clinical trial information: NCT05066646 .
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
向上发布了新的文献求助10
1秒前
3秒前
kongkong完成签到,获得积分20
3秒前
4秒前
心落失完成签到,获得积分10
4秒前
小不点点完成签到,获得积分10
5秒前
5秒前
缓慢的翅膀完成签到,获得积分10
6秒前
西门吹雪9527完成签到,获得积分10
6秒前
赵峰完成签到,获得积分10
6秒前
脑洞疼应助向上采纳,获得10
7秒前
美丽谷蕊完成签到,获得积分10
7秒前
艺术大师完成签到,获得积分10
8秒前
华仔应助tier3采纳,获得10
9秒前
Tian完成签到,获得积分10
9秒前
9秒前
10秒前
lengyue发布了新的文献求助10
10秒前
共享精神应助orange采纳,获得10
10秒前
自然天思发布了新的文献求助10
10秒前
三颗板牙完成签到,获得积分10
10秒前
团团关注了科研通微信公众号
10秒前
VirgoYn完成签到,获得积分10
11秒前
林林完成签到 ,获得积分10
12秒前
yi111完成签到,获得积分10
12秒前
找找找文献完成签到,获得积分10
13秒前
titamisulydia发布了新的文献求助10
14秒前
Liberal-5完成签到 ,获得积分10
17秒前
xiaobai完成签到,获得积分10
17秒前
HEIKU应助活力菠萝采纳,获得10
17秒前
18秒前
XH发布了新的文献求助10
18秒前
芳芳发布了新的文献求助10
20秒前
小甜水完成签到,获得积分10
21秒前
今后应助titamisulydia采纳,获得10
22秒前
22秒前
22秒前
希望天下0贩的0应助LIXI采纳,获得10
23秒前
lengyue完成签到,获得积分10
23秒前
活泼半凡完成签到 ,获得积分10
24秒前
高分求助中
Sustainability in Tides Chemistry 2800
The Young builders of New china : the visit of the delegation of the WFDY to the Chinese People's Republic 1000
Rechtsphilosophie 1000
Bayesian Models of Cognition:Reverse Engineering the Mind 888
Very-high-order BVD Schemes Using β-variable THINC Method 568
Chen Hansheng: China’s Last Romantic Revolutionary 500
XAFS for Everyone 500
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3137174
求助须知:如何正确求助?哪些是违规求助? 2788210
关于积分的说明 7784949
捐赠科研通 2444164
什么是DOI,文献DOI怎么找? 1299822
科研通“疑难数据库(出版商)”最低求助积分说明 625576
版权声明 601011