NCT Number: NCT07586618
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Children's Hospital Colorado, Aurora, Colorado, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
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.
Time frame: Through study duration, an average of 1 year
Assessment of safety and tolerability of 4A10 as measured by the incidence, severity, and relationship of treatment-emergent adverse events, as graded by CTCAE v6, in participants receiving study treatment at each dose-level in the 3+3 dose escalation study design.
Time frame: Through study duration, an average of 1 year
Determination of the RP2D/RDE of ALT-101 based on evaluation of safety, tolerability, and available pharmacokinetic and pharmacodynamic data following dose-escalation.
Time frame: Through study duration, an average of 1 year
Complete Remission (CR) Rate Percentage of participants who achieve Complete Remission (CR) according to standardized disease response criteria.
Time frame: Through study duration, an average of 1 year
Cmax (Maximum Observed Concentration):
The highest observed plasma (or serum) concentration of 4A10 following administration. This parameter reflects the peak systemic exposure achieved after dosing.
Time frame: Through study duration, an average of 1 year
Tmax (Time to Maximum Concentration):
The time elapsed from 4A10 administration to the occurrence of Cmax. This parameter describes the rate of absorption and systemic exposure onset.
Time frame: Through the study duration, an average of 1 year.
AUC (Area Under the Concentration-Time Curve):
The integral of the plasma concentration-time curve over a defined time interval (e.g., AUC₀-t and/or AUC₀-∞), representing the total systemic exposure to 4A10 over time.
Time frame: Through the study duration, an average of 1 year
T½ (Elimination Half-Life):
The time required for the plasma concentration of 4A10 to decrease by 50% during the terminal elimination phase. This parameter reflects the rate of systemic drug elimination.
Time frame: Through the study duration, an average of 1 year
Vd (Volume of Distribution):
A theoretical volume representing the extent to which 4A10 distributes into tissues relative to plasma. It provides insight into the drug's tissue distribution characteristics.
Time frame: Through the study duration, an average of 1 year
CL (Clearance):
The rate at which 4A10 is removed from systemic circulation, typically expressed as volume per unit time. This parameter reflects the efficiency of drug elimination via metabolic and/or excretory pathways.
Time frame: Through study duration, an average of 1 year.
Complete Remission With Incomplete Count Recovery (CRi) Rate Percentage of participants who achieve Complete Remission with Incomplete Count Recovery (CRi) according to standardized disease response criteria.
Time frame: Through study duration, an average of 1 year
Measurable Residual Disease (MRD) Negativity Rate Percentage of participants achieving MRD-negative status among participants who achieve CR or CRi.
Time frame: Through study duration, an average of 1 year
Duration of Response (DOR) Time from first documented CR or CRi to disease relapse, progression, or death from any cause, whichever occurs first.
Time frame: Through study duration, an average of 1 year
Time to Response (TTR) Time from initiation of study treatment to first documented achievement of CR or CRi.
Time frame: Through study duration, an average of 1 year
Event-Free Survival (EFS) Time from initiation of study treatment to treatment failure, relapse, or death from any cause.
Time frame: Through the study duration, an average of 1 year
Time to Progression (TTP) Time from initiation of study treatment to documented disease progression.
Time frame: Through study duration, an average of 1 year
Overall Survival (OS) Time from initiation of study treatment to death from any cause.
Time frame: Through study duration, an average of 1 year
Rate of Hematopoietic Stem Cell Transplantation (HSCT) Percentage of participants proceeding to hematopoietic stem cell transplantation following study treatment.
Time frame: Through study duration, an average of 1 year
Transfusion Independence Rate Percentage of participants achieving transfusion independence during study treatment and follow-up.
Contact information is provided by the study sponsor or research team.
Shibani M Kudchadkar, MD
CONTACT
Yan Moore, MD, MBA
CONTACT
Allterum Therapeutics, Inc
Industry
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
Acronym: ALT-101
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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