Rebecca Araujo

Urban Health Today

The novel chimeric antigen receptor (CAR) T cell therapy, CT053, achieved a 100% overall response rate (ORR) for the treatment of relapsed/refractory <a href="https://www.docwirenews.com/condition-center/multiple-myeloma-knowledge-hub/recent-fda-approvals-for-multiple-myeloma-and-what-to-expect-from-treatments-in-development/" target="_blank" rel="noopener noreferrer">multiple myeloma</a> (RRMM), though toxicity was common, according to data presented at the American Society of Hematology 2020 virtual annual conference (<a href="https://ash.confex.com/ash/2020/webprogram/Paper139802.html">abstract #133</a>).CT053 is a second-generation CAR T that incorporates a fully human <a href="https://www.docwirenews.com/condition-center/multiple-myeloma-knowledge-hub/multiple-myeloma-picks/bcma-cd30-bispecific-antibody-induces-response-in-relapsed-refractory-multiple-myeloma/" target="_blank" rel="noopener noreferrer">B-cell maturation antigen</a> (BCMA)-specific single-chain fragment variant. In a phase I study, CT053 induced responses in 87.5% of patients with RRMM, including 79.2% achieving a complete response (CR), for a median duration of 21.8 months.The phase Ib LUMMICAR-2 study enrolled 20 patients with RRMM whose disease persisted after &ge;3 prior lines of therapy. Participants received 500 mg/m2 cyclophosphamide for two days and 25 mg/m2 fludarabine daily three days. Following lymphodepletion, a single infusion of CT053 was administered at the 1.5-3.0&times;108 CAR+ T-cell target dose. At data cutoff, 14 patients received infusion and 10 were evaluated after a median 4.5 months. Primary endpoints were safety and tolerability, and identification of recommended dosing for phase II.An ORR of 100% was achieved, with two stringent CRs, two CRs, one very good partial response, and five partial responses. Eleven of twelve patients with evaluable bone marrow samples were minimal-residual disease (MRD)-negative. All subjects showed declines in serum free light chains and soluble BCMA (sBCMA) levels at one month, with continued sBCMA depletion. Cytokine levels increased post-infusion and correlated with the onset of cytokine release syndrome (CRS) symptoms.Toxicity was common, with twelve subjects (86%) experiencing grade 1 or 2 CRS, and one subject experiencing grade 2 neurotoxicity. CRS events occurred a median two days post-infusion with a median duration of four days. No &ge; grade 3 CRS or neurotoxicity was observed. All subjects experienced &ge; grade 3 neutropenia and leukopenia, and 36% had &ge; grade 3 thrombocytopenia.&ldquo;Collectively, these results demonstrate that CT053 at a target dose of 1.5-3.0&times;108 CAR+ T cells delivers early and deep responses, including MRD negativity, with an acceptable safety profile in subjects with heavily pretreated relapsed or refractory MM. The promising results from the ongoing LUMMICAR-2 study are consistent with the previous phase I studies and support the launch of a pivotal phase II LUMMICAR-2 study,&rdquo; the researchers concluded.<blockquote class="twitter-tweet">
Results from Lummicar-2: A Phase 1b/2 Study of Fully Human B-Cell Maturation Antigen-Specific CAR T Cells (CT053) in Patients with Relapsed and/or Refractory Multiple Myeloma 
&ndash; What is CT053 
&ndash; Trial Design 
&ndash; Inclusion criteria <a href="https://twitter.com/myelomaMD?ref_src=twsrc%5Etfw">@myelomaMD</a> <a href="https://twitter.com/hashtag/ASH20?src=hash&amp;ref_src=twsrc%5Etfw">#ASH20</a> <a href="https://twitter.com/hashtag/IMFASH20?src=hash&amp;ref_src=twsrc%5Etfw">#IMFASH20</a> <a href="https://twitter.com/hashtag/MMSM?src=hash&amp;ref_src=twsrc%5Etfw">#MMSM</a> <a href="https://t.co/HIxafnQAJJ">pic.twitter.com/HIxafnQAJJ</a>
&mdash; =NorthTX Yelak= (@NorthTxMSG) <a href="https://twitter.com/NorthTxMSG/status/1335294851726925825?ref_src=twsrc%5Etfw">December 5, 2020</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script><blockquote class="twitter-tweet">
Report on LUMMICAR2 from <a href="https://twitter.com/myelomaMD?ref_src=twsrc%5Etfw">@myelomaMD</a> with CT053, fully humanized BCMA CAR T, Ph1b/2 in 20 pts. No grade 3 or higher CRS, 94% ORR <a href="https://t.co/tXgS7UOkY5">pic.twitter.com/tXgS7UOkY5</a>
&mdash; Multiple Myeloma RF (@theMMRF) <a href="https://twitter.com/theMMRF/status/1335304205964353543?ref_src=twsrc%5Etfw">December 5, 2020</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>

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LUMMICAR-2: CT053 BCMA CAR T Is Active in Refractory Myeloma, But Toxicity Persists

Multiple Myeloma

The novel chimeric antigen receptor (CAR) T cell therapy, CT053, achieved a 100% overall response rate (ORR) for the ...