Clinical trial Recruiting at 5 sites Phase 1 Interventional Ages 18 and up

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.

More Lymphoblastic Lymphoma trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment24 (estimated)
SponsorAllterum Therapeutics, Inc
Industry-sponsored
Locations7 sites (Aurora, Colorado and 6 other locations)
StatusRecruiting
StartedJune 1, 2026
Main results expectedMay 2028
Study endsSeptember 2028
Registry record updatedSeptember 1, 2026
Trial IDNCT07586618 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

  • 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
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.