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Cited by 36CAR-T cell therapy researchMultiple Myeloma Research and TreatmentsProtein Degradation and Inhibitors

The DOI matches its Crossref record.

Updated results of a phase I, open-label study of BCMA/CD19 dual-targeting fast CAR-T GC012F for patients with relapsed/refractory multiple myeloma (RRMM).

Du, Juan, Fu, Wei-Jun, Jiang, Hua, Dong, Baoxia, Gao, Li, Liu, Li, Ge, Jian, He, Aili, Li, Lu, Lu, Jing, Chen, Xiequn, Liu, Jia, Zhang, Qi, He, Jiaping, Shen, Lianjun, Weng, Lihong, Zhang, Hua, Cao, Wei, Li, Wenling·2023·Journal of Clinical Oncology
DOI 10.1200/jco.2023.41.16_suppl.8005
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Abstract

8005 Background: GC012F is a chimeric antigen receptor (CAR)-T cell therapy with B cell maturation antigen (BCMA) and CD19 dual-target developed on the novel FasT CAR-T platform enabling 22-36 h manufacturing. Our previous results were presented at ASCO and EHA 2022 for 29 pts (NCT04236011; NCT04182581), which demonstrated GC012F treatment led to deep and durable response in RRMM pts. Furthermore, initial results showed that GC012F showed considerable efficacy and safety in high-risk transplant-eligible newly diagnosed MM pts (Blood 2022; 140 (Supplement 1): 889–890). Here we present update on RRMM study with a longer median follow-up. Methods: From October 2019 to January 2022, 29 heavily pretreated RRMM pts (age 27-76) with a median of 5 prior lines therapies (range 2-9) received GC012F. 26 (89.7%) pts were high risk (HR- mSMART), 8 (27.6%) pts had EM disease, 24 (82.8%) pts were refractory to last therapy. 10 (34.5%) pts had received prior anti-CD38 and 11 (37.9%) pts were treated with auto-HSCT. After lymphodepletion over 2-3 days (30 mg/m 2/d, 300mg/m 2/d Flu/Cy), GC012F was administered as single infusion at 3 dose levels: 1x10 5/kg (DL1) n=2, 2x10 5/kg (DL2) n=10 and 3x10 5/kg (DL3) n=17. Results: At the time of data cut-off (January 30, 2023), 29 eligible pts had been evaluated for response with the last patient completed 12 months efficacy follow up. Overall response rate was 93.1% (27/29), stringent complete response rate was 82.8% (24/29), ≥very good partial response rate was 89.7% (26/29). All patients dosed (29/29) achieved MRD negativity by flow cytometry (sensitivity 10-4-10-6). To date 24/29 patients (82.8%) achieved MRD- sCR across all dose levels. According to the Kaplan-Meier method, the median duration of response (DOR) was 37.0 months (95%CI, 11.0-NR) and the median progression free survival (PFS) was 38.0 months (95%CI, 11.8-NR). Cytokine Release Syndrome (CRS) was reported in 25 (86.2%) pts, which was mostly ≤grade 2 (n=23, 79.3%) and 2 (6.9%) pts were grade 3. No ICANS was observed (Graded by ASBMT criteria). Median duration of CRS was 3 days (1-8 d). PK results showed no difference amongst dose levels DL1 to DL3. The median time of persistence was 410 days (range: 51-1183) and GC012F was still detectable in 23 (79.3%) pts at 6 months and in 16 (55.2%) pts at 12 months after infusion. sBCMA plasma levels started declining at day 4 in 80% (8/10) patients, falling sharply at day 10 in 100% (19/19), and reaching minimal levels from 30 to 60 days post infusion in 100% (29/29) patients. Conclusions: The updated results showed GC012F continues to provide deep and durable responses, and a very high MRD negativity ratein RRMM pts, including in pts refractory to anti-CD38, PIs and IMIDs. Based on these promising results of the study of GC012F for RRMM, further clinical studies will be conducted to confirm the efficacy of GC012F. Clinical trial information: NCT04236011 ; NCT04182581 .

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  • In an open-label phase I study of GC012F for RRMM, the ORR was 93.1%, sCR was 82.8%, and VGPR was 89.7%.

    “The reported the ORR was 93.1%, sCR was 82.8%, and VGPR was 89.7%.”

    From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [253]

  • All patients in that study achieved MRD negativity.

    “All patients achieved MRD negativity.”

    From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [253]

  • The median follow-up was 30.7 months, mDOR was 37.0 months, and mPFS was 38.0 months.

    “The median follow-up was 30.7 months, mDOR was 37.0 months, and mPFS was 38.0 months [253].”

    From Multiple myeloma: signaling pathways and targeted therapy (2024) · cites this paper as [253]

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Metadata

Authors
Du, J., Fu, W.-J., Jiang, H., Dong, B., Gao, L., Liu, L., Ge, J., He, A., Li, L., Lu, J., Chen, X., Liu, J., Zhang, Q., He, J., Shen, L., Weng, L., Zhang, H., Cao, W., & Li, W.
Affiliations
  • Shanghai Changzheng Hospital (CN)
  • Shanghai Changzheng Hospital, Shanghai, China
  • Xijing Hospital (CN)
  • Army Medical University (CN)
  • Tang Du Hospital (CN)
  • First Affiliated Hospital of Anhui Medical University (CN)
  • Second Affiliated Hospital of Xi'an Jiaotong University (CN)
  • Gracell Biotechnologies Ltd, Shanghai, China
  • Gracell Biotechnologies, Ltd, Shanghai, China
ORCID
Venue
Journal of Clinical Oncology
Publisher
American Society of Clinical Oncology (ASCO)
Published
2023-06-01
Volume
41
Issue
16_suppl
Pages
8005-8005
ISSN
  • 0732-183X (ISSN-L)
  • 1527-7755
DOI
10.1200/jco.2023.41.16_suppl.8005
OpenAlex
W4379339320
Cited by
35
References
0
Citations by year
2026: 4 · 2025: 10 · 2024: 14 · 2023: 7
Type
conference abstract
Language
en
Open access
closed
Locations
Journal of Clinical Oncology (publishedVersion)
Funders
Gracell Biotechnologies Ltd, Shanghai, China
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Protein Degradation and Inhibitors
Keywords
relapsed/refractory multiple myeloma, CAR T cell manufacturing, high-risk myeloma, stringent complete response, progression-free survival, overall survival, minimal residual disease, dose escalation, autologous stem cell transplantation

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