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RecruitingPhase 1

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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In this study, patients receive 4A10 through an intravenous (IV) infusion once a week."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests 4A10, a new antibody drug, in people with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma that has come back or is hard to treat. The drug targets a protein on cancer cells and is given through a vein once a week. Researchers will check its safety, dose, how the body handles it, and early signs that it may work.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You have a confirmed diagnosis of T-cell or B-cell ALL or lymphoblastic lymphoma, which are blood cancers.
  • Your cancer has come back or has not responded to treatment, and no treatment option is expected to cure it.
  • Your organs work well enough, and you are well enough to carry out daily activities as required by the study.

Who can't join

  • You have CNS3 disease, a defined level of cancer involving the brain or spinal cord.
  • You have a condition that makes DNA fragile, such as Fanconi or Bloom syndrome, or you have Down syndrome.
  • You have had treatment that targets the CD127 protein before.
  • You have an infection that is not under control.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (7)

CO

IN

NY

OH

PA

TX