4A10 for Acute Lymphoblastic Leukemia
(ALT-101 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug called 4A10 for individuals with difficult-to-treat blood cancers, such as acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. The drug targets a specific protein on cancer cells, aiming to halt their growth and make them visible to the immune system. Participants will receive the drug through an IV once a week to assess its safety and effectiveness. Suitable candidates for this trial have these cancers, have not responded to other treatments, and maintain good overall organ function. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that 4A10 is likely to be safe for humans?
Research shows that 4A10, a new antibody drug, is undergoing its first human trials. This means limited information exists about its safety in people. However, earlier studies in labs and on animals demonstrated that 4A10 effectively targets leukemia cells. These studies suggest potential effectiveness, but researchers are closely monitoring for any side effects in humans.
As an early-phase trial, the primary goal is to determine 4A10's safety and identify any side effects. Patients receive careful monitoring, especially during the initial weeks, allowing researchers to quickly detect any issues. If patients tolerate the treatment well, they can continue receiving it.
It's important to note that as an early-stage trial, the treatment is still under safety evaluation. Participants contribute to researchers' understanding of the drug's effects.12345Why do researchers think this study treatment might be promising for acute lymphoblastic leukemia?
Unlike the standard of care for acute lymphoblastic leukemia, which typically includes chemotherapy and sometimes targeted therapies, 4A10 is a novel treatment administered intravenously. Researchers are excited about 4A10 because it potentially offers a new mechanism of action, targeting leukemia cells in a unique way that current treatments do not. This could mean more effective treatment options and possibly fewer side effects for patients, making it a promising development in the fight against this aggressive cancer.
What evidence suggests that 4A10 might be an effective treatment for acute lymphoblastic leukemia?
Research shows that 4A10 is a new drug designed to fight leukemia by targeting a protein called CD127 on leukemia cells. This protein aids cancer cell survival and growth. By attaching to CD127, 4A10 blocks growth signals and helps the immune system attack the cancer cells. Early studies on similar treatments suggest that targeting proteins on cancer cells can effectively treat difficult cases of acute lymphoblastic leukemia (ALL). Although data on 4A10 remains limited, it is based on proven methods for fighting leukemia. Participants in this trial will receive 4A10 intravenously, following the protocol-defined dosing schedule in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation per investigator decision.678910
Who Is on the Research Team?
Eric Schafer, MD
Principal Investigator
Baylor College of Medicine
Are You a Good Fit for This Trial?
This trial is for children and adults with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma that has come back or hasn't responded to treatment. Participants must have these hard-to-treat blood cancers and be able to safely receive IV infusions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4A10 through an intravenous (IV) infusion once a week. The study starts with small groups of patients receiving increasing doses to carefully monitor safety.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events and preliminary anti-tumor activity.
What Are the Treatments Tested in This Trial?
Interventions
- 4A10
Trial Overview
The study tests a new antibody drug called 4A10, given by weekly IV infusion. It aims to find the safest dose, see how the body handles the drug, and look for early signs it helps fight cancer. Doses start low and increase in small groups of patients.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants receive 4A10 administered by intravenous route according to the protocol-defined dosing schedule in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation per investigator decision.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Allterum Therapeutics, Inc
Lead Sponsor
Cancer Prevention Research Institute of Texas
Collaborator
National Cancer Institute (NCI)
Collaborator
Citations
Acute lymphoblastic leukemia: A population-based study of ...
3.2 |. Overall outcomes. The 5-year overall survival rate for the total population by treatment decade was 51% in 1980–1989, 61% in 1990–1999, 67% in 2000–2009, ...
Acute Lymphoblastic Leukemia Survival Rate by Age & Type
In the United States, the overall 5-year relative survival rate for ALL is about 72.6%, but survival in children approaches 90%, while adult ...
final results of the ALL-4 randomized, phase III trial ...
The 6-year cumulative incidences of relapse were 49.8% and 53.5% (Gray's test: =0.30) while the 6-year cumulative incidences of death were 18% ...
Outcomes In Older Adults with Acute Lymphoblastic Leukemia ...
93%, p<0.0001) as was five-year overall survival (21% vs. 41%, p<0.0001) and event-free survival (EFS) (19% vs. 37%, p<0.0001). Older patients had more ...
5.
hematologyadvisor.com
hematologyadvisor.com/news/prognostic-outcomes-in-adolescent-acute-lymphoblastic-leukemia/Outcomes for Adolescents With Acute Lymphoblastic ...
A total of 11 patients with B-lineage ALL died. The 8-year event-free survival (EFS) rate was 72.3% (95% CI, 59.4%-81.7%), and the 8-year ...
First-in-human Study of a New Treatment (4A10) for ...
The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look for early signs ...
Allterum's 4A10 Enters Phase I Trial for Leukemia
The primary objectives are to establish the recommended Phase II dose and to characterize the safety profile of 4A10 monotherapy through ...
Abstract 7044: In vitro and in vivo activity of the CD127 ...
4A10 is a monoclonal antibody targeting CD127 (IL-7R alpha) under planned clinical development for treatment of patients with relapsed/refractory (r/r) acute ...
EXPANDED ACCESS POLICY
Allterum Therapeutics is developing 4A10 as an investigational therapy for patients with T-cell Acute Lymphoblastic Leukemia (T-ALL).
First-in-human Study of a New Treatment (4A10) for Patients ...
The main goal of the trial is to find out if the drug is safe, what dose can be given, and how the body processes it. Researchers will also look ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.