Tag Archives: NDMM

GC012F’s US Trial in MM Initiates Dosing; GC012F IND in SLE on Track for 2023; Gracell Initiates GC506 Clinical Development in Solid Tumors and Deprioritizes GC007g in B-ALL; Gracell’s Q3 2023 Earnings Call Summary

On Monday, November 13, Gracell held its Q3 2023 earnings call (press release) highlighting the initiation of dosing in the Ph1b/2 trial evaluating GC012F (BCMA x CD19 FasTCAR-T) for ≥4L MM in the US, while confirming that the IND submissions for the evaluation of GC012F in refractory SLE (rSLE) in the US and China remain on track for 2023. Additionally, the company disclosed the initiation of GC506 (CLDN18.2 SMART CAR-T) clinical development in solid tumors and the discontinuation of GC007g (allogeneic CD19 CAR-T) in B-ALL. Below, Celltelligence provides insights on GC012F potential in MM and rSLE while discussing possible causes of GC007g discontinuation and the initiation of the clinical evaluation of a CLL-1 x CD38 dual CAR-T in AML.

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GC012F Results in MM and NHL to Be Presented at ASCO and EHA; New GC012F Trial in SLE; GC007g Demonstrates Remarkable Ph1 IIT Results in ALL; Gracell’s Q1 2023 Earnings Call Summary

On Monday, May 15, Gracell held its Q1 2023 earnings call (press release) highlighting the presentation of results from GC012F (BCMA x CD19 FasTCAR-T) and GC007g (allogeneic CD19 CAR-T) in several hematological indications at ASCO and EHA 2023, while disclosing the initiation of a Ph1 IIT evaluating GC012F in refractory systemic lupus erythematosus (SLE). Below, Celltelligence provides insights on the interest of Gracell in establishing a collaboration for the development of the GC012F’s Ph1b/2 trial for ≥4L MM to be initiated in the US, while comparing GC012F to its main competitors in the SLE field.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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GC012F’s Ph1/2 Trials in the US and China to Initiate in 2023; Will FasTCAR-Ts be as Fast as Initially Thought? Gracell’s Q4 2022 Earnings Call Summary

On Monday, March 13, Gracell held their Q4 and FY 2022 earnings call (press release / presentation) highlighting the upcoming initiation of GC012F’s (autologous BCMA x CD19 FasTCAR-T) Ph1/2 trials for r/r MM in the US and China. Additionally, management reported clinical updates for GC007g (allogeneic CD19 CAR-T) and GC506 (CLDN18.2 SMART CAR-T). Below, Celltelligence provides insights on Gracell’s potential partnership for advancing the clinical development of GC012F in the US, while discussing if fast manufacturing platforms will ultimately be able to differentiate themselves from traditional autologous CAR-Ts.

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The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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Gracell to Submit GC012F’s IND for R/R MM in the US and China; GC012F Demonstrates 100% ORR in NDMM; Clinical Progress from GC007g, GC503, and GC506; Gracell’s Q3 2022 Earnings Call Summary

On Monday, November 14, Gracell held their Q3 2022 earnings call (press release / presentation), highlighting results from GC012F’s (autologous BCMAxCD19 FasTCAR-T) Ph1/2 IIT in NDMM, and planned IND submissions in the US and China for r/r MM. Additionally, management provided clinical updates for GC007g (allogeneic CD19 CAR-T), GC503 (mesothelin SMART CAR-T), and GC506 (CLDN18.2 SMART CAR-T). Below, Celltelligence provides insights on GC012F’s potential as a first-line treatment in MM, while discussing a possible partnership strategy in the US.

About The Author

The Celltelligence Team

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Content Leads & Contributors

The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.

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