16CT022: A Phase 2 two cohort study of the tocilizumab optimization timing for CART19 (CTL019) associated cytokine release syndrome (CRS) management in pediatric patients with CD19 expressing relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) (CHOP IRB # 16-013097)
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- STATUS
- None
Summary
CART-19 cells transduced with a lentiviral vector to express either anti-CD19 scFv TCR:41BB, administered by i.v. injection using an intra-patient dose escalation approach: 10% on day 0, 30% on day 1 with a total dose goal of ~1.5 x10^7 5 x10^9 (~0.3x10^6 - 1.0x10^8/kg) T cells. Two cohorts are defined based upon pre-infusion high versus low tumor burden; with the high tumor burden cohort to receive protocol defined early anti-cytokine intervention (i.e. tocilizumab) for CRS management and the low tumor burden cohort to receive standard anti-cytokine intervention (i.e. tocilizumab) for CRS. All screening, enrollment, treatment and follow-up procedures will take place at CHOP only. Activity at the University of Pennsylvania is limited to sponsor-related responsibilities, including data analysis/review, collection and analysis of research samples from CHOP subjects for the manufacturing of investigational product by CVPF, and site monitoring per the study DSMP.
Details
| Condition | TBD, tbd, tbd |
|---|---|
| Age | 99years or below |
| Clinical Study Identifier | TBD |
| Last Modified on | 19 February 2024 |
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