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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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Confirmed diagnosis of T/B-ALL or T/B-LL

• Relapsed or refractory disease without curative options

• Adequate organ function and performance status

Locations
United States
Colorado
Children's Hospital Colorado
NOT_YET_RECRUITING
Aurora
Pennsylvania
Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
Texas
Cook Children's Medical Center
RECRUITING
Fort Worth
Texas Children's Hospital
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Shibani M Kudchadkar, MD
skudchadkar@allterum.com
15153439875
Backup
Yan Moore, MD, MBA
ymoore@allterum.com
6178004959
Time Frame
Start Date: 2026-06-01
Estimated Completion Date: 2028-09
Participants
Target number of participants: 24
Treatments
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.
Sponsors
Collaborators: Cancer Prevention Research Institute of Texas, National Cancer Institute (NCI)
Leads: Allterum Therapeutics, Inc

This content was sourced from clinicaltrials.gov

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