MCW-XEN21: A Phase 1 Study of XmAb18968 (CD3-CD38) for the Treatment of Patients With Relapsed/Refractory CD38 Positive Acute Leukemia and T Cell Lymphoblastic Lymphoma

This is a phase 1, dose-escalation study (using 3 + 3 dose-limiting toxicity (DLT) criteria) evaluating the safety and tolerability of XmAb18968, as well as establishing a recommended phase II dose (RP2D) in subjects with T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic (lymphoma) T-LBL (Group A) and acute myeloid leukemia (AML) (Group B).

Start Date02 Feb 2022

Sponsor / Collaborator

Medical College of Wisconsin

NCT03445663

/ TerminatedPhase 1

A Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 424 in Subjects With Multiple Myeloma

A multi-center Phase 1, First-in-Human study conducted in 2 Parts, testing AMG 424 in subjects with relapsed/ refractory multiple myeloma.

Start Date31 Jul 2018

Sponsor / Collaborator

Xencor, Inc.

100 Clinical Results associated with XmAb968

100 Translational Medicine associated with XmAb968

100 Patents (Medical) associated with XmAb968

Literatures (Medical) associated with XmAb968

01 Jul 2019·Clinical Cancer ResearchQ1 · MEDICINE

Targeting Multiple Myeloma with AMG 424, a Novel Anti-CD38/CD3 Bispecific T-cell–recruiting Antibody Optimized for Cytotoxicity and Cytokine Release

Q1 · MEDICINE

Article

Author: Muchhal, Umesh S. ; McElroy, Patricia L. ; Case, Ryan ; Canon, Jude ; Desjarlais, John R. ; Balazs, Mercedesz ; Bernett, Matthew J. ; Pearson, Joshua T. ; Moore, Gregory L. ; Coxon, Angela ; Stevens, Jennitte ; Nolan-Stevaux, Olivier ; Zhong, Wendy ; Zuch de Zafra, Christina L. ; Fajardo, Flordeliza ; Liu, Siyuan

AbstractPurpose:Despite advances in the treatment of multiple myeloma, new therapies are needed to induce more profound clinical responses. T-cell–redirected lysis triggered by bispecific antibodies recruiting T cells to cancer cells is a clinically validated mechanism of action against hematologic malignancies and CD38 is a tumor-associated antigen with near-universal expression in multiple myeloma. Thus, an anti-CD38/CD3 bispecific T-cell–recruiting antibody has the potential to be an effective new therapeutic for multiple myeloma.Experimental Design:Anti-CD38/CD3 XmAb T-cell–recruiting antibodies with different affinities for CD38 and CD3 were assessed in vitro and in vivo for their redirected T-cell lysis activity against cancer cell lines, their lower levels of cytokine release, and their potency in the presence of high levels of soluble CD38. Select candidates were further tested in cynomolgus monkeys for B-cell depletion and cytokine release properties.Results:AMG 424 was selected on the basis of its ability to kill cancer cells expressing high and low levels of CD38 in vitro and trigger T-cell proliferation, but with attenuated cytokine release. In vivo, AMG 424 induces tumor growth inhibition in bone marrow–invasive mouse cancer models and the depletion of peripheral B cells in cynomolgus monkeys, without triggering excessive cytokine release. The activity of AMG 424 against normal immune cells expressing CD38 is also presented.Conclusions: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 patients with multiple myeloma.

100 Deals associated with XmAb968

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Multiple Myeloma	Phase 2	United States	Xencor, Inc.	31 Jul 2018
Refractory Multiple Myeloma	Phase 2	Australia	Xencor, Inc.	31 Jul 2018
Relapse multiple myeloma	Phase 2	Australia	Xencor, Inc.	31 Jul 2018
Relapse multiple myeloma	Phase 2	United States	Xencor, Inc.	31 Jul 2018
Acute Lymphoblastic Leukemia	Phase 1	United States	Xencor, Inc.	-
Acute Myeloid Leukemia	Phase 1	United States	Xencor, Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05038644 (ASH2023) Manual	Phase 1	Acute Myeloid Leukemia	12	XmAb18968	(quqnxytxzb) = mwmxzrgebs gyciifysjd (zocqchsxpc ) View more	Positive	09 Dec 2023

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