PMID- 36269898
OWN - NLM
STAT- MEDLINE
DCOM- 20230217
LR  - 20230403
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 41
IP  - 6
DP  - 2023 Feb 20
TI  - Phase II, Open-Label Study of Ciltacabtagene Autoleucel, an Anti-B-Cell 
      Maturation Antigen Chimeric Antigen Receptor-T-Cell Therapy, in Chinese Patients 
      With Relapsed/Refractory Multiple Myeloma (CARTIFAN-1).
PG  - 1275-1284
LID - 10.1200/JCO.22.00690 [doi]
AB  - PURPOSE: CARTIFAN-1 aimed to evaluate the efficacy and safety of ciltacabtagene 
      autoleucel (cilta-cel), a B-cell maturation antigen-targeting chimeric antigen 
      receptor T-cell therapy, in Chinese patients with relapsed/refractory multiple 
      myeloma (RRMM). METHODS: This pivotal phase II, open-label study 
      (ClinicalTrials.gov identifier: NCT03758417), conducted across eight sites in 
      China, enrolled adult patients with RRMM who had received >/= 3 lines of prior 
      therapy, including a proteasome inhibitor and immunomodulatory drug. Patients 
      received a single infusion of cilta-cel (target dose 0.75 x 10(6) chimeric 
      antigen receptor-positive viable T cells/kg). The primary end point was overall 
      response rate. Secondary end points included progression-free survival (PFS), 
      overall survival (OS), and incidence and severity of adverse events (AEs). 
      RESULTS: As of the clinical cutoff of July 19, 2021, 48 patients received a 
      cilta-cel infusion. At an 18-month median follow-up, the overall response rate 
      was 89.6% (95% CI, 77.3 to 96.5), with a median time to first response of 
      approximately 1 month; 77.1% of patients (95% CI, 62.7 to 88.0) achieved complete 
      response or better. Medians for duration of response, PFS, and OS were not 
      reached. The 18-month PFS and OS rates were 66.8% (95% CI, 49.4 to 79.4) and 
      78.7% (95% CI, 64.0 to 88.0), respectively. Hematologic AEs were common, 
      including anemia (100%), neutropenia (97.9%), lymphopenia (95.8%), and 
      thrombocytopenia (87.5%). Cytokine release syndrome occurred in 97.9% of patients 
      (35.4% grade 3/4); the median time to onset was 7 days, and the median duration 
      was 5 days. Infections occurred in 85.4% of patients (37.5% grade 3/4). Ten 
      deaths occurred after cilta-cel infusion, eight of which were due to 
      treatment-related AEs. CONCLUSION: These data demonstrate a favorable 
      risk-benefit profile for a single infusion of cilta-cel, resulting in early, 
      deep, and durable responses in heavily pretreated patients with RRMM in China.
FAU - Mi, Jian-Qing
AU  - Mi JQ
AUID- ORCID: 0000-0002-0769-5437
AD  - Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, 
      National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, 
      Shanghai Jiao Tong University School of Medicine, Shanghai, China.
FAU - Zhao, Wanhong
AU  - Zhao W
AUID- ORCID: 0000-0001-6285-4093
AD  - The Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, ShaanXi, 
      China.
FAU - Jing, Hongmei
AU  - Jing H
AD  - Peking University Third Hospital, Beijing, China.
FAU - Fu, Weijun
AU  - Fu W
AUID- ORCID: 0000-0002-5908-0207
AD  - Shanghai Changzheng Hospital and Department of Hematology, Shanghai Fourth 
      People's Hospital, School of Medicine, Tongji University, Shanghai, China.
FAU - Hu, Jianda
AU  - Hu J
AD  - Fujian Medical University Union Hospital, Fuzhou, Fujian, China.
FAU - Chen, Lijuan
AU  - Chen L
AD  - Jiangsu Province Hospital, Nanjing, Jiangsu, China.
FAU - Zhang, Yiwen
AU  - Zhang Y
AD  - Legend Biotech China, Nanjing, Jiangsu, China.
FAU - Yao, Dan
AU  - Yao D
AD  - Janssen China Research & Development, Shanghai, China.
FAU - Chen, Diana
AU  - Chen D
AUID- ORCID: 0000-0002-2097-0317
AD  - Janssen China Research & Development, Shanghai, China.
FAU - Schecter, Jordan M
AU  - Schecter JM
AD  - Janssen Research & Development, Raritan, NJ.
FAU - Yang, Fan
AU  - Yang F
AD  - Janssen China Research & Development, Shanghai, China.
FAU - Tian, Xiaochen
AU  - Tian X
AD  - Janssen China Research & Development, Shanghai, China.
FAU - Sun, Huabin
AU  - Sun H
AD  - Janssen Research & Development, Raritan, NJ.
FAU - Zhuang, Sen Hong
AU  - Zhuang SH
AD  - Janssen China Research & Development, Shanghai, China.
FAU - Ren, Jimmy
AU  - Ren J
AD  - Janssen China Research & Development, Shanghai, China.
FAU - Fan, Xiaohu
AU  - Fan X
AD  - Legend Biotech China, Nanjing, Jiangsu, China.
FAU - Jin, Jie
AU  - Jin J
AUID- ORCID: 0000-0003-4617-2601
AD  - First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, 
      Zhejiang, China.
FAU - Niu, Ting
AU  - Niu T
AUID- ORCID: 0000-0003-1580-1014
AD  - West China Hospital, Sichuan University, Chengdu, Sichuan, China.
FAU - Chen, Sai-Juan
AU  - Chen SJ
AUID- ORCID: 0000-0003-3789-1284
AD  - Shanghai Institute of Hematology, State Key Laboratory of Medical Genomics, 
      National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, 
      Shanghai Jiao Tong University School of Medicine, Shanghai, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03758417
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221021
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (B-Cell Maturation Antigen)
RN  - 0 (Receptors, Chimeric Antigen)
SB  - IM
MH  - Adult
MH  - Humans
MH  - *Anemia/etiology
MH  - B-Cell Maturation Antigen
MH  - Cell- and Tissue-Based Therapy
MH  - East Asian People
MH  - Immunotherapy, Adoptive
MH  - *Multiple Myeloma/drug therapy
MH  - *Receptors, Chimeric Antigen/therapeutic use
EDAT- 2022/10/22 06:00
MHDA- 2023/02/18 06:00
CRDT- 2022/10/21 16:03
PHST- 2022/10/22 06:00 [pubmed]
PHST- 2023/02/18 06:00 [medline]
PHST- 2022/10/21 16:03 [entrez]
AID - 10.1200/JCO.22.00690 [doi]
PST - ppublish
SO  - J Clin Oncol. 2023 Feb 20;41(6):1275-1284. doi: 10.1200/JCO.22.00690. Epub 2022 
      Oct 21.