First-in-human Study of 4A10 for Relapsed or Hard-to-Treat ALL or Lymphoblastic Lymphoma
This is a first-in-human clinical trial testing a new antibody drug called 4A10 for patients aged 18 and older with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma that has come back or is hard to treat. 4A10 is a targeted therapy that works by attaching to a specific protein (CD127) on cancer cells, blocking their growth, and helping your immune system fight them. You would receive 4A10 through an IV once a week. The main goals are to see if 4A10 is safe, find the right dose, understand how your body handles it, and look for early signs that it might be working. This study is currently recruiting, with a plan for 24 participants.
- Study design
- This is an interventional study with a planned enrollment of 24 participants. It is a first-in-human study, meaning it's the first time this drug is being tested in people.
- What's involved
- You would receive 4A10 through an intravenous (IV) infusion once a week. The study duration is an average of 1 year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for an average of 1 year to monitor for side effects and determine the recommended dose.
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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.
At a glance
Conditions
Where it's being run
5 sites across 4 statesStudy leadership
- Eric Schafer, MD · STUDY_CHAIR · Baylor College of Medicine
Who to contact
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What this trial measures
- Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose levelThrough study duration, an average of 1 year
Assessment of safety and tolerability of 4A10 as measured by the incidence, severity, and relationship of treatment-emergent adverse events, as graded by CTCAE v6, in participants receiving study treatment at each dose-level in the 3+3 dose escalation study design.
- Determine the Recommended Phase 2 Dose (RP2D)/ Recommended Dose for Expansion (RDE) of 4A10 as a single agent in patients with R/R ALL/LL.Through study duration, an average of 1 year
Determination of the RP2D/RDE of ALT-101 based on evaluation of safety, tolerability, and available pharmacokinetic and pharmacodynamic data following dose-escalation.