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.
About this 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.
- Condition
- Lymphoblastic Lymphoma, Acute Lymphoblastic Leukemia ALL
- Tested
- 4A10
- Sponsor
- Allterum Therapeutics, Inc
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 5
- Minimum age: 18 years
- Study condition: Lymphoblastic Lymphoma, Acute Lymphoblastic Leukemia ALL
- Confirmed diagnosis of T/B-ALL or T/B-LL
- Relapsed or refractory disease without curative options
- Adequate organ function and performance status
Exclusion 4
- Patients with CNS3 disease
- Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)
- Prior exposure to anti-CD127 therapies
- Uncontrolled infections
Where
7 sites, 7 recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Cook Children's Medical Center
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Riley Children's Hosptial
Indianapolis, Indiana, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
and 1 more site on ClinicalTrials.gov
Contact
-
Shibani M Kudchadkar, MD
15153439875 skudchadkar@allterum.com
-
Yan Moore, MD, MBA
6178004959 ymoore@allterum.com
Potential match only. Final eligibility is determined by the study team.