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DRUG:

JNJ-67571244

i
Other names: JNJ-67571244, JNJ 67571244, JNJ-1244
Associations
Company:
J&J
Drug class:
CD3 agonist, CD33 inhibitor
Related drugs:
Associations
8ms
First-in-human study of JNJ-67571244, a CD33 × CD3 bispecific antibody, in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome. (PubMed, Clin Transl Sci)
T-cell activation following treatment suggested target engagement but did not correlate with clinical activity. Safely reaching the projected exposure level for JNJ-67571244 efficacy was not achieved, thus MTD and RP2D were not determined.
P1 data • Clinical Trial,Phase I • Journal
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CD33 (CD33 Molecule)
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JNJ-67571244
1year
CD33-Deleted Hematopoietic Cells (Trem-Cel) Are Protected from CD33xCD3 Bispecific Antibody Treatment and Produce Significantly Reduced Levels of Inflammatory Cytokines in Preclinical Studies (ASH 2023)
Taken together, these studies demonstrate that CD33 deleted hematopoietic compartment is protected from the CD33 directed immuno-therapy JNJ-67571244 both in in vitro cytotoxicity assays and preclinical xenotransplantation studies, with decreased concentrations of inflammatory cytokines associated with CRS. These findings enable the development of a next-generation AML treatment strategy by pairing trem-cel transplant with a subsequent CD33-directed bispecific compound to potentially improve safety and efficacy while minimizing myelotoxicity.
Preclinical • IO biomarker
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • IL2RA (Interleukin 2 receptor, alpha) • CD33 (CD33 Molecule) • CD34 (CD34 molecule) • CD69 (CD69 Molecule) • IL2 (Interleukin 2) • IL10 (Interleukin 10) • CD14 (CD14 Molecule) • ANXA5 (Annexin A5)
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JNJ-67571244
over2years
A Study of JNJ-67571244 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
P1, N=68, Completed, Janssen Research & Development, LLC | Active, not recruiting --> Completed | Trial completion date: Oct 2022 --> Mar 2022
Trial completion • Trial completion date
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IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • CD33 (CD33 Molecule) • IL10 (Interleukin 10)
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JNJ-67571244
almost3years
A Study of JNJ-67571244 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
P1, N=68, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | N=180 --> 68
Enrollment closed • Enrollment change
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IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • CD33 (CD33 Molecule) • IL10 (Interleukin 10)
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JNJ-67571244
over3years
A Study of JNJ-67571244 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
P1, N=180, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jun 2021 --> Jan 2022
Clinical • Trial primary completion date
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IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • CD33 (CD33 Molecule) • IL10 (Interleukin 10)
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JNJ-67571244
over3years
A Study of JNJ-67571244 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
P1, N=180, Recruiting, Janssen Research & Development, LLC | Trial completion date: Jan 2022 --> Oct 2022
Clinical • Trial completion date
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IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • CD33 (CD33 Molecule) • IL10 (Interleukin 10)
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JNJ-67571244
4years
Enrollment change • Clinical
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IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • CD33 (CD33 Molecule) • IL10 (Interleukin 10)
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JNJ-67571244
5years
Trial completion date • Clinical
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IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • CD33 (CD33 Molecule) • IL10 (Interleukin 10)
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JNJ-67571244
over5years
New P1 trial • Clinical
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IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • CD33 (CD33 Molecule) • IL10 (Interleukin 10)
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JNJ-67571244