PMID- 34362494
OWN - NLM
STAT- MEDLINE
DCOM- 20210810
LR  - 20210810
IS  - 1009-2137 (Print)
IS  - 1009-2137 (Linking)
VI  - 29
IP  - 4
DP  - 2021 Aug
TI  - [Anti-CD19 CART (C-CAR011) Therapy for Relapsed or Refractory B-Cell Non-Hodgkin 
      Lymphoma].
PG  - 1141-1147
LID - 10.19746/j.cnki.issn.1009-2137.2021.04.019 [doi]
AB  - OBJECTIVE: To evaluate the safety and efficacy of C-CAR011 in the treatment of 
      relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients. METHODS: 
      B-NHL patients treated with C-CAR011 infusion following lympho-depletion were 
      enrolled. All the patients were followed up for 1 year after C-CAR011 
      treatment(5.0x10(6) /kg). The primary endpoint of this research was safety; and 
      the secondary endpoints included objective response rate (ORR), progression-free 
      survival (PFS), duration of overall response (DOR), overall survival (OS) at Week 
      4, 12 and Month 6 and 12. RESULTS: The ratio of the male and female of 6 patients 
      was 1ratio1, and the patients were treated with C-CAR011 at a dose of 5.0x10(6) /kg. 
      The median age was 46.5 years old (37-62 years); 5 patients were diagnosed as 
      diffuse large b-cell lymphoma (DLBCL) and 1 patient was diagnosed as follicular 
      lymphoma (FL). The most common adverse events (AEs) were hematological toxicities 
      (100%, Grade 3-4), cytokine release syndrome (CRS) (66.7%, Grade 1-3), 
      neurotoxicity (16.7%, Grade 3). All these AEs were reversible and could be 
      conversed. The ORR at Week 4, 12 and Month 6, 12 were 50%(3/6), 50%(3/6), 
      16.7%(1/6) and 16.7%(1/6), respectively. Three patients (50%) achieved complete 
      response (CR) and one of them stayed evaluated as CR until Month 12. The median 
      PFS was 178 days (91->365 days). For 3 patients with response, the DOR were 150 
      days, 154 days and >12 months, respectively. The OS rates of the patients at Week 
      12, Month 6, 12 were 100%, 100%, 83.3%, respectively, while the median OS was not 
      reached. CONCLUSION: C-CAR011 is a safe treatment option for R/R B-NHL; some 
      patients could achieve long-term sustained responses after C-CAR011 
      infusion（ClinicalTiral.gov number, NCT03483688）.
FAU - Zhang, Lu
AU  - Zhang L
AD  - Department of Hematology, Peking Union Medical College Hospital, Chinese Academy 
      of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
FAU - Zhang, Yan
AU  - Zhang Y
AD  - Department of Hematology, Peking Union Medical College Hospital, Chinese Academy 
      of Medical Sciences and Peking Union Medical College, Beijing 100730, China.
FAU - Zhou, Dao-Bin
AU  - Zhou DB
AD  - Department of Hematology, Peking Union Medical College Hospital, Chinese Academy 
      of Medical Sciences and Peking Union Medical College, Beijing 100730, 
      China,E-mail: zhoudb@pumch.cn.
LA  - chi
SI  - ClinicalTrials.gov/NCT03483688
PT  - Journal Article
PL  - China
TA  - Zhongguo Shi Yan Xue Ye Xue Za Zhi
JT  - Zhongguo shi yan xue ye xue za zhi
JID - 101084424
RN  - 0 (Antigens, CD19)
SB  - IM
MH  - Antigens, CD19/therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols
MH  - B-Lymphocytes
MH  - Female
MH  - Humans
MH  - *Lymphoma, Follicular
MH  - *Lymphoma, Large B-Cell, Diffuse
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/drug therapy
MH  - Treatment Outcome
EDAT- 2021/08/08 06:00
MHDA- 2021/08/11 06:00
CRDT- 2021/08/07 05:32
PHST- 2021/08/07 05:32 [entrez]
PHST- 2021/08/08 06:00 [pubmed]
PHST- 2021/08/11 06:00 [medline]
AID - 1009-2137(2021)04-1141-07 [pii]
AID - 10.19746/j.cnki.issn.1009-2137.2021.04.019 [doi]
PST - ppublish
SO  - Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2021 Aug;29(4):1141-1147. doi: 
      10.19746/j.cnki.issn.1009-2137.2021.04.019.