First-in-human testing of 4A10 for relapsed or hard-to-treat ALL and lymphoblastic lymphoma
Official title: A First in Human, Phase 1, Open-Label Study on the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 4A10 Monotherapy In Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
Run by Allterum Therapeutics, Inc · NCT07586618 · Data updated 2026-11-12
This early-stage trial tests a new antibody therapy called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia or lymphoblastic lymphoma to see if it is safe and how the body handles it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Allterum Therapeutics, Inc Industry-sponsored |
| Locations | 7 sites (Aurora, Colorado and 6 other locations) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | May 2028 |
| Study ends | September 2028 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT07586618 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with relapsed or refractory T/B-ALL or T/B-LL who have adequate organ function and performance status and no CNS3 disease or certain genetic conditions.
✕Probably not a fit
Patients with uncontrolled infections, prior exposure to anti-CD127 therapies, or specific high-risk conditions may not benefit and could be at higher risk for adverse effects.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, first-in-human study of 4A10, a CD127-targeting antibody. Participants with relapsed or refractory ALL or lymphoblastic lymphoma receive weekly IV infusions of 4A10 to determine safety, dosing, and pharmacokinetics, while monitoring for early signs of activity. The study uses a cautious dose-escalation approach in small cohorts, with close observation during the initial treatment cycle (about 4–6 weeks). Primary goals focus on safety and identifying a recommended dose, with exploratory assessments of anti-leukemic effects.
Why it matters
Potential benefit: If successful, 4A10 could offer a new treatment option by targeting leukemia cells and engaging the immune system.
How similar studies have gone: Previous studies of CD127-targeted approaches in blood cancers have demonstrated safety signals and potential activity, but this 4A10 trial is an early, first-in-human evaluation with novel delivery assumptions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Confirmed diagnosis of T/B-ALL or T/B-LL 2. Relapsed or refractory disease without curative options 3. Adequate organ function and performance status Key Exclusion Criteria: 1. Patients with CNS3 disease 2. Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome) 3. Prior exposure to anti-CD127 therapies 4. Uncontrolled infections
Where it's running
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Children's Hospital Colorado
Aurora, Colorado, United States Recruiting -
Riley Children's Hosptial
Indianapolis, Indiana, United States Recruiting -
Memorial Sloan Kettering Cancer Center
New York, New York, United States Recruiting -
Cook Children's Medical Center
Fort Worth, Texas, United States Recruiting -
Texas Children's Hospital
Houston, Texas, United States Recruiting -
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States Not yet recruiting
Show 1 more location
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States Not yet recruiting
Study contacts
- Study coordinator: Shibani M Kudchadkar, MD
- Email: skudchadkar@allterum.com
- Phone: 15153439875
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.