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4ms
Lentivirally Redirected CD123 Autologous T Cells in AML (clinicaltrials.gov)
P1, N=22, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting | N=12 --> 22 | Trial primary completion date: Aug 2024 --> Dec 2033
Enrollment closed • Enrollment change • Trial primary completion date
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cyclophosphamide • fludarabine IV • CART123
5ms
CD123 Redirected T Cells for AML in Pediatric Subjects (clinicaltrials.gov)
P1, N=18, Recruiting, University of Pennsylvania | Active, not recruiting --> Recruiting | N=12 --> 18
Enrollment open • Enrollment change
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cyclophosphamide • fludarabine IV • CART123
7ms
Lentivirally Redirected CD123 Autologous T Cells in AML (clinicaltrials.gov)
P1, N=12, Recruiting, University of Pennsylvania | Active, not recruiting --> Recruiting
Enrollment open
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cyclophosphamide • fludarabine IV • CART123
1year
Cytokine Release Syndrome Results in Reduced AML Killing By CD123 CAR T Cells (ASH 2023)
Fludarabine and cyclophosphamide were used for lymphodepletion (LD)...Finally, we found that anti-apoptotic effects of cytokines can be prevented, and CART-123 killing of AML can be restored, via ruxolitinib blockade of JAK/STAT signaling in both in vitro and in vivo settings... We conducted a pilot study of CD123-directed CAR T cells (CART-123) in adults with relapsed or refractory AML. The primary objective was safety with a secondary objective of anti-leukemia efficacy. Twenty-two subjects were screened, and 20 were eligible for the trial.
CAR T-Cell Therapy
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FLT3 (Fms-related tyrosine kinase 3) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD4 (CD4 Molecule) • CSF2 (Colony stimulating factor 2) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
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CD123 expression • CD4 expression • IL3RA expression
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Jakafi (ruxolitinib) • cyclophosphamide • fludarabine IV • CART123
2years
Ameli-01: A Phase I Trial of UCART123v1.2, an Anti-CD123 Allogeneic CAR-T Cell Product, in Adult Patients with Relapsed or Refractory (R/R) CD123+ Acute Myeloid Leukemia (AML) (ASH 2022)
AMELI-01 (NCT04106076) is a phase 1, open-label, dose-escalation trial evaluating the safety, tolerability, expansion, and persistence of UCART123v1.2 given at escalating dose levels after LD with either fludarabine and cyclophosphamide (FC) or FC with alemtuzumab (FCA) in patients (pts) with R/R CD123+ AML...Pts must have received ≥2 cycles of chemotherapy (one with standard dose cytarabine), ≥ 1 cycle of a high/intermediate dose cytarabine containing regimen, ≥ 2 cycles of an HMA combination regimen, or prior allogeneic HSCT... Adding alemtuzumab to the FC regimen was associated with improved LD and significantly higher UCART123v1.2 cell expansion and persistence, which correlated with improved activity and safety, including one pt in the DL2 FCA arm who achieved a durable MRD-negative CR. Overall, these data support the safety and activity of UCART123v1.2 after FCA LD in pts with CD123+ R/R AML.
Clinical • P1 data • CAR T-Cell Therapy • IO biomarker
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CD123 (Interleukin 3 Receptor Subunit Alpha) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • IL15 (Interleukin 15)
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CD123 positive • CD123 expression
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cytarabine • cyclophosphamide • Campath (alemtuzumab) • fludarabine IV • UCART123 • CART123