XmAb13676 for Leukemia, Lymphocytic, Chronic, B-Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Leukemia, Lymphocytic, Chronic, B-Cell+6 More
XmAb13676 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it is safe and how well it is tolerated. They will also determine the Maximum Tolerated Dose (MTD) or Recommended Dose (RD).

Eligible Conditions
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Chronic Lymphocytic Leukemia (CLL)
  • B-Lymphocytes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Leukemia, Lymphocytic, Chronic, B-Cell

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Baseline Day 1 through Day 56

Day 56
Identify maximum tolerated (MTD) and/or recommended dose (RD) and schedule for XmAb13676 dosing
Safety and tolerability as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Safety as determined by the number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Trial Safety

Safety Progress

1 of 3

Other trials for Leukemia, Lymphocytic, Chronic, B-Cell

Trial Design

5 Treatment Groups

CLL/SLL (Group CLL) Part A
1 of 5
CLL/SLL (Group CLL) Part B
1 of 5
Non-CLL B Cell Malignancies (Group NHL) Expansion
1 of 5
Non-CLL B Cell Malignancies (Group NHL) Part B
1 of 5
Non-CLL B Cell Malignancies (Group NHL) Part A
1 of 5
Experimental Treatment

160 Total Participants · 5 Treatment Groups

Primary Treatment: XmAb13676 · No Placebo Group · Phase 1

CLL/SLL (Group CLL) Part A
Biological
Experimental Group · 1 Intervention: XmAb13676 · Intervention Types: Biological
CLL/SLL (Group CLL) Part B
Biological
Experimental Group · 1 Intervention: XmAb13676 · Intervention Types: Biological
Non-CLL B Cell Malignancies (Group NHL) Expansion
Biological
Experimental Group · 1 Intervention: XmAb13676 · Intervention Types: Biological
Non-CLL B Cell Malignancies (Group NHL) Part B
Biological
Experimental Group · 1 Intervention: XmAb13676 · Intervention Types: Biological
Non-CLL B Cell Malignancies (Group NHL) Part A
Biological
Experimental Group · 1 Intervention: XmAb13676 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline day 1 through day 56

Who is running the clinical trial?

Xencor, Inc.Lead Sponsor
20 Previous Clinical Trials
2,035 Total Patients Enrolled
1 Trials studying Leukemia, Lymphocytic, Chronic, B-Cell
27 Patients Enrolled for Leukemia, Lymphocytic, Chronic, B-Cell
ICON Clinical ResearchIndustry Sponsor
45 Previous Clinical Trials
13,343 Total Patients Enrolled
David Liebowitz, MDStudy DirectorVP, Clinical Oncology, Clinical Development, Xencor, Inc.
2 Previous Clinical Trials
282 Total Patients Enrolled
Raman Garcha, MDStudy DirectorMedical Director, Clinical Development, Xencor, Inc.
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The text states that the individual has a histologically confirmed diagnosis of DLBCL or transformed low-grade lymphoma
The patient has a good performance status.
A patient must either be refractory to or have relapsed after two or more standard treatments, at least one of which must have included an anti-CD20 antibody therapy.
Fertile patients must agree to use contraception during and for 5 months (male patients) and 8 months (female patients) after the last dose of XmAb13676.
Inclusion criteria for the expansion phase include patients who have a confirmed diagnosis of DLBCL, meet the eligibility criteria for participation in the study, and have consented to participate in the study
cannot be made based on morphology and immunophenotype Neither non-CLL B cell malignancy nor CLL/SLL can be accurately diagnosed based on morphology and immunophenotype.
This text is saying that the person has tried all the standard therapies and they haven't worked, so they are looking for other options.
The subject was able and willing to complete the entire study.
You are not a candidate for or refusing treatment with hematopoietic stem cell transplantation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: October 5th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.