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DRUG:

XmAb968

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Other names: XmAb968, AMG 424, XmAb13551, AMG424, XmAb18968
Associations
Company:
Xencor
Drug class:
CD3 agonist, CD38 inhibitor
Related drugs:
Associations
5ms
PRO00041908: XmAb18968 (CD3-CD38) in Relapsed or Refractory Acute Leukemia and T Cell Lymphoblastic Leukemia (clinicaltrials.gov)
P1, N=22, Active, not recruiting, Ehab L Atallah | Recruiting --> Active, not recruiting | N=60 --> 22 | Trial completion date: Oct 2026 --> Apr 2025 | Trial primary completion date: Oct 2025 --> Apr 2024
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
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CD38 (CD38 Molecule)
|
XmAb968
1year
A Phase 1 Study of CD38-Bispecific Antibody (XmAb18968) for Patients with Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (ASH 2023)
Major exclusion criteria are hematopoietic cell transplantation within 6 months of enrollment, prior therapy with daratumumab in the last 6 months and active acute graft-versus-host disease. XmAb18968, a novel CD-38 bispecific antibody appears safe and is showing response at the starting dose level in T-ALL. The study is currently enrolling additional patients with T-ALL. Updated analysis with additional patients and details on correlative studies examining mechanisms of therapeutic efficacy will be reported at the main meeting.
Clinical • P1 data • IO biomarker
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CD7 (CD7 Molecule)
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Darzalex (daratumumab) • XmAb968
1year
A Phase 1 Study of CD38-Bispecific Antibody (XmAb18968) for Patients with CD38 Expressing Relapsed/Refractory Acute Myeloid Leukemia (ASH 2023)
Twelve of 13 patients (92%) were previously treated with venetoclax based regimen and 31% had prior allogeneic HCT. XmAb18968 is safe and well tolerated in patients with RR-AML. Dose escalation yielded MRD negative CR in RR-AML patients who were MRD positive at study entry. Details on correlative studies examining mechanisms of therapeutic efficacy and resistance will be reported in the main meeting.
Clinical • P1 data • IO biomarker
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TP53 (Tumor protein P53) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1) • CD38 (CD38 Molecule)
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TP53 mutation • CD38 expression
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Venclexta (venetoclax) • XmAb968
over2years
Enrollment open
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CD38 (CD38 Molecule)
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CD38 expression
|
XmAb968
3years
XmAb18968 (CD3-CD38) in Relapsed or Refractory Acute Leukemia and T Cell Lymphoblastic Leukemia (clinicaltrials.gov)
P1, N=60, Not yet recruiting, Ehab L Atallah | Initiation date: Oct 2021 --> Jan 2022
Clinical • Trial initiation date
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CD38 (CD38 Molecule)
|
CD38 expression
|
XmAb968
3years
Clinical • New P1 trial
|
CD38 (CD38 Molecule)
|
CD38 expression
|
XmAb968
over4years
Targeting Multiple Myeloma with AMG 424, a Novel Anti-CD38/CD3 Bispecific T Cell-Recruiting Antibody Optimized for Cytotoxicity and Cytokine Release. (PubMed, Clin Cancer Res)
These findings support the clinical development of AMG 424, an affinity-optimized T cell-recruiting antibody with the potential to elicit significant clinical activity in MM patients.
Journal
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CD38 (CD38 Molecule)
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CD38 expression
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XmAb968