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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.

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

Who can join

Ages 18 and older · All sexes

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

About the study

ALT-101 is a first-in-human Phase 1 clinical trial testing a new antibody drug called 4A10 in patients with relapsed or hard-to-treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma.

4A10 is a targeted therapy designed to recognize and attach to a specific protein (CD127) found on leukemia cells. Once it binds, it works in two ways: it blocks growth signals that help cancer cells survive, and it helps the immune system find and destroy those cancer cells.

In this study, patients receive 4A10 through an intravenous (IV) infusion once a week. 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 that the treatment may be working.

The study starts with small groups of patients receiving increasing doses to carefully monitor safety. Each patient is closely observed during the first treatment cycle (about 4-6 weeks) to watch for side effects. If the treatment is helping and is well tolerated, patients may continue treatment for up to six cycles.

Overall, this study is an early step in testing a new, targeted immune-based therapy for difficult-to-treat blood cancers.

What is being tested

• 4A10 (drug)

Sponsor: Allterum Therapeutics, Inc · Participants: 24 · Started: Jun 1, 2026

Contact the study team

• Shibani M Kudchadkar, MD · Phone: 15153439875
• Yan Moore, MD, MBA · Phone: 6178004959

Official record on ClinicalTrials.gov — NCT07586618

Locations in the U.S.

Conditions

• Acute Lymphoblastic Leukemia
• Leukemia

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.