Recruiting
Phase 1

4A10

Sponsor:

Allterum Therapeutics, Inc

Code:

NCT07586618

Conditions

Lymphoblastic Lymphoma

Acute Lymphoblastic Leukemia ALL

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

4A10

Study Details

Brief summary:

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.

Conditions

Lymphoblastic Lymphoma

Acute Lymphoblastic Leukemia ALL

Study ID

NCT07586618

Start date

Jun 1, 2026

Status verified date

Aug, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

4A10

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.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level [ Time Frame: Through study duration, an average of 1 year ]
  • Determine the Recommended Phase 2 Dose (RP2D)/ Recommended Dose for Expansion (RDE) of 4A10 as a single agent in patients with R/R ALL/LL. [ Time Frame: Through study duration, an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Riley Children's Hosptial

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Sandeep Batra, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Juliette Wiseman Site Contact

855-762-0678wisemanj@mskcc.org

Principal Investigator:

Maria Luisa Sulis, MD

Cook Children's Medical Center

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Holly Pacenta, MD

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

Allterum Therapeutics, Inc

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • Leukemia
  • Refractory
  • Relapsed

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Allterum Therapeutics, Inc on 2026-09-01.