Actively Recruiting
First in Human Phase 1 Study of 4A10 Antibody Treatment in Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Led by Allterum Therapeutics, Inc · Updated on 2026-06-03
24
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
Sponsors
A
Allterum Therapeutics, Inc
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma. This early Phase 1 trial tests 4A10, a targeted therapy designed to attach to a specific protein (CD127) on leukemia cells, aiming to block cancer growth signals and help the immune system destroy these cells. The study focuses on safety, dosing, how the drug behaves in the body, and early signs of effect. Participants receive 4A10 through an intravenous infusion once a week in 28-day treatment cycles. The study begins with small groups receiving increasing doses to monitor safety closely during the first treatment cycle lasting about 4 to 6 weeks. If well tolerated and showing benefit, patients may continue treatment for up to six cycles or until disease progression or other stopping reasons. Throughout the trial, patients are carefully monitored for side effects and drug effects. Researchers track adverse events and determine the best dose for future studies. They also study the drug's behavior in the body and look for initial signs that the treatment might be working. The total study duration averages about one year, including safety and effectiveness assessments.
CONDITIONS
Brief Title
First-in-human Study of a New Treatment (4A10) for Patients With Relapsed or Hard-to-treat Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma, Focused on Safety and How the Drug Behaves in the Body and Early Signs of Effect.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of T-cell or B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma
- Relapsed or refractory disease without curative treatment options
- Adequate organ function and performance status
- Age 18 years or older
You will not qualify if you...
- Presence of CNS3 disease
- DNA fragility syndromes such as Fanconi or Bloom syndrome
- Diagnosis of trisomy 21 (Down Syndrome)
- Prior treatment with anti-CD127 therapies
- Uncontrolled infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive 4A10 administered by intravenous route in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation per investigator decision.
Visits each cycle for drug administration and monitoring
Trial Site Locations
Total: 2 locations
1
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
2
Texas Children's Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
S
Shibani M Kudchadkar, MD
Y
Yan Moore, MD, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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