2025 ASH: Johnson & Johnson Reports Updated Phase 1b Clinical Data and Biomarker Analysis of Prizlo-cel (JNJ-90014496), a Bispecific CD19/CD20 CAR-T Therapy

On the 9th of this month, Johnson & Johnson at the 65th American Society of Hematology（ASH）Updated its dual-target CAR-T therapy Prizlo-cel in an oral presentation at the annual meeting.（JNJ-90014496）Phase 1b Clinical Trial Data and Biomarker Correlation Analysis.

This pipeline originated from the global collaboration between Johnson & Johnson and Cellular Biomedicine Group (CBMG) reached in 2023, and the Johnson & Johnson official website has included it into the heavy-hitter pipeline matrix with "annual sales peak exceeding 5 billion US dollars." In June, the phase 1b clinical data of Prizlo-cel was presented at the European Hematology Association.（EHA）Debuted at the conference, this ASH report further supplements the details on safety, efficacy, and in-depth analysis at the mechanistic level. Let's take a look.

Prizlo-cel is an optimized CAR design dual-antigen targeting CD20/CD19 CAR-T therapy, aimed at binding to CD19 and CD20 antigens, which are common cell surface proteins found on malignant B cells. Structurally, Prizlo-cel belongs to the "fifth generation" of CAR-T, incorporating a co-stimulatory domain of 4-1BB+CD28 and a tandem structure of CD19 and CD20 scFv. Compared with traditional CAR-T, this structure effectively prevents antigen escape and reduces off-target effects. Currently, only about 40% of patients achieve long-term remission through existing single-antigen targeting CD19 CAR-T cell therapy.

From the clinical data, 51 R/R LBCL patients received treatment without prophylaxis, with the incidence of Grade 3 ICANS and CRS being only 8% and 4%, respectively. The ORR reached 91%, and the CR rate was 75%, which is significantly better than the historical data of traditional CD19 CAR-T. Observing the correlation between ICANS grading and CAR-T cell levels, the median levels of the three groups were very close. The median in Grade 3 was slightly higher, but high peak concentration samples were also observed in Grades 1 and 2, showing no significant association between ICANS severity and CAR-T cell expansion. Additionally, regarding CRS and CAR-T cell levels, mild to moderate CRS was associated with higher CAR-T expansion.(Grade 1-2 group had higher blood drug concentration), but the relationship between severe CRS and CAR-T expansion is not obvious. In summary, we can see the balance of Prizlo-cel in terms of safety and efficacy.

In addition to the data on efficacy and safety, Johnson & Johnson also presented several relationships between biomarkers and clinical outcomes in their oral report. For instance, the expansion of CAR-T cells and high complete remission rates at different CD20 and CD19 antigen expression levels, the comparison of CAR-T cell expansion and persistence at different test doses, and the degree of B-cell depletion.

Overall, Johnson & Johnson（Johnson & Johnson）With CBMG Biotech（AbelZeta）This novel CD20/CD19 dual-target CAR-T cell therapy, jointly developed to overcome the limitations of antigen escape and tumor heterogeneity associated with traditional single-target CAR-T therapies through innovative design, has demonstrated significant advantages in safety, efficacy, and biomarker correlation analysis in global Phase 1b clinical trial data. It provides deeper disease remission for R/R LBCL patients and is expected to prolong their progression-free survival. The subsequent Phase 2 clinical trial results will further validate its long-term efficacy and safety—let us all look forward to it!

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