Your session is about to expire
← Back to Search
Monoclonal Antibodies
Plamotamab for Blood Cancers
Phase 1
Waitlist Available
Research Sponsored by Xencor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-2
Able and willing to complete the entire study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline day 1 through day 56
Awards & highlights
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).
Who is the study for?
This trial is for patients with certain blood cancers like lymphoma and leukemia who have tried all standard treatments without success. They should be in a stable condition (ECOG 0-2), not planning stem cell transplants, and must agree to effective contraception. Excluded are those with severe recent illness, heart or lung issues, high toxicity from past treatments, CNS lymphoma, active infections or autoimmune diseases.Check my eligibility
What is being tested?
The study tests the safety of XmAb13676 (Plamotamab) given through IV or SC injections in different doses to find the highest dose patients can tolerate without serious side effects. It's aimed at people whose cancer hasn't responded well to other therapies including anti-CD20 antibody treatment.See study design
What are the potential side effects?
Potential side effects aren't detailed here but generally could include reactions at injection sites, immune system responses affecting various organs, fatigue, allergic reactions due to antibodies present in the drug and possibly others as determined during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
Select...
I am willing and able to participate in the whole study.
Select...
I have been diagnosed with DLBCL or transformed low-grade lymphoma.
Select...
My DLBCL has not responded to at least 2 treatments, including one with anti-CD20.
Select...
I am not eligible for or am refusing stem cell transplant for my DLBCL.
Select...
I have been diagnosed with follicular lymphoma Grades 1-3a.
Select...
My condition has not improved with standard treatments or I have no other treatment options.
Select...
I have tried 2 or more treatments for my Follicular Lymphoma without success.
Select...
My diagnosis is a non-CLL B cell cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline day 1 through day 56
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline day 1 through day 56
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Trial Design
6Treatment groups
Experimental Treatment
Group I: Non-CLL B Cell Malignancies (Group NHL) Part D / ExpansionExperimental Treatment1 Intervention
XmAb13676 administered SC up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Group II: Non-CLL B Cell Malignancies (Group NHL) Part C / ExpansionExperimental Treatment1 Intervention
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Group III: Non-CLL B Cell Malignancies (Group NHL) Part BExperimental Treatment1 Intervention
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Group IV: Non-CLL B Cell Malignancies (Group NHL) Part AExperimental Treatment1 Intervention
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Group V: CLL/SLL (Group CLL) Part BExperimental Treatment1 Intervention
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Group VI: CLL/SLL (Group CLL) Part AExperimental Treatment1 Intervention
XmAb13676 administered IV up to 8 weeks, if receiving benefit, this can be extended at investigator's discretion
Find a Location
Who is running the clinical trial?
ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
15,102 Total Patients Enrolled
Xencor, Inc.Lead Sponsor
29 Previous Clinical Trials
2,483 Total Patients Enrolled
Chet Bohac, PharmD, MD, MScStudy DirectorExecutive Medical Director, Clinical Development, Xencor, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had chemotherapy, radiotherapy, or immunotherapy in the last 4 weeks.I have had brain lymphoma or cancer affecting my nervous system.I have been diagnosed with multiple myeloma, plasma cell leukemia, or B cell acute lymphoblastic leukemia.I am allergic or have had a bad reaction to CD20 monoclonal antibody therapy.My bilirubin levels are high, but it's due to a known condition.I have a seizure disorder.I haven't had serious infections in the last 30 days.I can take care of myself and am up and about more than half of the day.I am willing and able to participate in the whole study.I have been diagnosed with DLBCL or transformed low-grade lymphoma.My DLBCL has not responded to at least 2 treatments, including one with anti-CD20.I am not eligible for or am refusing stem cell transplant for my DLBCL.I have been diagnosed with follicular lymphoma Grades 1-3a.I have serious heart or lung problems.I have had a solid organ transplant.I still have severe side effects from my last treatment.I have an autoimmune disease that is not under control.My kidney function is reduced with a creatinine clearance below 40 mL/min.I have not had a stroke in the last 6 months.I have tested positive for hepatitis B but am either vaccinated, have no active infection, or am on preventive treatment.My condition has not improved with standard treatments or I have no other treatment options.I have tried 2 or more treatments for my Follicular Lymphoma without success.My diagnosis is a non-CLL B cell cancer.I have not received a live vaccine within 2 weeks before starting XmAb13676.
Research Study Groups:
This trial has the following groups:- Group 1: CLL/SLL (Group CLL) Part B
- Group 2: Non-CLL B Cell Malignancies (Group NHL) Part B
- Group 3: Non-CLL B Cell Malignancies (Group NHL) Part C / Expansion
- Group 4: Non-CLL B Cell Malignancies (Group NHL) Part D / Expansion
- Group 5: Non-CLL B Cell Malignancies (Group NHL) Part A
- Group 6: CLL/SLL (Group CLL) Part A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many potential participants are being accepted for this clinical experiment?
"Indeed, the details listed on clinicaltrials.gov affirm that this medical experiment is actively recruiting participants. This trial was initially posted in October 2016 and last revised in October 2021; 160 individuals are required to be enrolled from 7 distinct centres."
Answered by AI
What deleterious effects might XmAb13676 have on individuals?
"At this stage, only limited data exists to support the safety and efficacy of XmAb13676. Our team at Power has thus assigned it a score of 1 on our scale from 1-3."
Answered by AI
Are there multiple clinical locations in the U.S. administering this research?
"The seven medical sites that are participating in this trial include the University of Michigan at Ann Arbor, Gabrail Cancer Center Research in Canton, and Mayo Clinic in Jacksonville. An additional 4 locations round out the list of enrolment centres."
Answered by AI
Are there any available enrolment slots for this research endeavor?
"Affirmative. The trial, which was initially made available on October 1st 2016, is actively seeking participants; clinicaltrials.gov provides evidence to this effect. 160 individuals are required from 7 distinct medical centres."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger