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Anti-CD19 CAR T-cell therapy with shRNA IL-6 gene silencing element for patients with R/R B-ALL
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CAR T-cell therapies have improved outcomes in patients with R/R B-ALL; however, CRS and ICANS can be a limiting factor.1 A novel anti-CD19 CAR T-cell product utilizing shRNA technology to silence the IL-6 gene of the CAR T-cell (ssCAR T-cell) was designed to reduce toxicities compared with common anti-CD19 CAR T-cell (cCAR T-cell).1 A post hoc analysis compared data from a phase I/II trial (NCT03275493; n = 47) of ssCAR T-cells and a phase I/II trial of cCAR T-cells (NCT03919240; n = 40) in patients with R/R B-ALL.1 Results from this analysis were published in Hemasphere by Ma et al.1 |
| Key learnings |
| On Day 28 post-infusion, response rates were similar between the two groups; CR/CRi rates were 91.49% and 85% in the ssCAR T-cell and the cCAR T-cell groups, respectively (p = 0.999). |
| Median PFS was 24.17 months and 9.33 months in the ssCAR T-cell and cCAR T-cell groups, respectively (p = 0.23), and median OS was 37.17 months and 32.93 months, respectively (p = 0.40). |
| The frequency of any grade AEs was similar between groups; however, fewer Grade ≥3 AEs were reported in the ssCAR T-cell group vs the cCAR T-cell group (p = 0.026). |
| The incidence of any-grade CRS (68.09% vs 85%) and Grade ≥3 CRS (14.89% vs 37.5%) and the incidence of any-grade ICANS (4.26% vs 15%) and Grade ≥3 ICANS (0% vs 5%) were lower in the ssCAR T-cell group vs cCAR T-cell group. |
| Results from this analysis suggest that ssCAR T-cell therapy may offer an improved safety profile when compared with cCAR T-cell therapy, without compromising efficacy, in patients with R/R B-ALL. |
Abbreviations: AE, adverse event; B-ALL, B-cell acute lymphoblastic leukemia; CAR, chimeric antigen receptor; cCAR, common CAR; CR, complete remission; CRi, CR with incomplete hematological recovery; CRS, cytokine release syndrome; ICANS, immune effector cell-associated neurotoxicity syndrome; IL, interleukin; OS, overall survival; PFS, progression-free survival; R/R, relapsed/refractory; shRNA, small hairpin RNA; ssCAR, CAR with shRNA-IL-6 gene silencing element.
- Ma JF, Yan JW, Liu MJ, et al. Safe and potent anti-CD19 CAR T-cells with shRNA-IL-6 gene silencing element in patients with refractory or relapsed B-cell acute lymphoblastic leukemia. 2024;8(10)e70007. DOI: 10.1002/hem3.70007
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