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.

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Allterum Therapeutics, Inc
Study ID
NCT07586618
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acute Lymphoblastic Leukemia ALL
  • Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 4A10 — DRUG
    4A10 (Molecule B4532) is an investigational human Immunoglobulin G Subclass 1 (IgG1) monoclonal antibody that specifically binds CD127 (Interleukin-7 receptor alpha subunit, IL-7Rα). CD127 is a component of the interleukin-7 receptor and the thymic stromal lymphopoietin receptor (TSLPR), which are expressed on T-cell acute lymphoblastic leukemia (T-ALL) and pre-B-cell acute lymphoblastic leukemia (B-ALL) cells.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
May 31, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Participants receive 4A10 administered by intravenous route according to the protocol-defined dosing schedule in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or discontinuation per investigator decision.

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level [ Time Frame: Through study duration, an average of 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Kelly Faulk, MD
[email protected]
(720)777-6740
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Susan Rheingold, MD
[email protected]
(267) 426-0762
Cook Children's Medical CenterFort WorthTexas76104
Heather Jernigan
[email protected]
682-885-2103
Andrea Martinez
[email protected]
682-303-3061
Holly Pacenta, MD (PRINCIPAL_INVESTIGATOR)
Texas Children's HospitalHoustonTexas77030
Eric Schafer, MD
[email protected]
(832) 822-3300

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