A Phase 1 interventional study of 4A10 in Lymphoblastic Lymphoma and Acute Lymphoblastic Leukemia ALL, sponsored by Allterum Therapeutics, Inc. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Allterum Therapeutics, Inc · Phase 1, Interventional, and Treatment
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.
2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.
This study's planned enrollment of 24 is below the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →This is the only study on the registry with Allterum Therapeutics, Inc as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: 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.
Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level
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
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.
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
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
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
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
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
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
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 study duration, an average of 1 year
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
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.
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
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
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
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
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
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 the study duration, an average of 1 year
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
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.
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
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
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
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
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
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
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
Event-Free Survival (EFS) Time from initiation of study treatment to treatment failure, relapse, or death from any cause.
Time frame: Through study duration, an average of 1 year
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
Time to Progression (TTP) Time from initiation of study treatment to documented disease progression.
Time frame: Through the study duration, an average of 1 year
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL
Overall Survival (OS) Time from initiation of study treatment to death from any cause.
Time frame: Through study duration, an average of 1 year
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL
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
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL
Transfusion Independence Rate Percentage of participants achieving transfusion independence during study treatment and follow-up.
Time frame: Through study duration, an average of 1 year
Plan to share: Yes — Allterum Therapeutics is committed to responsible sharing of clinical trial data in accordance with the recommendations of the International Committee of Medical Journal Editors (ICMJE), applicable laws and regulations, and protection of participant privacy. Individual participant data (IPD) that underlie the results reported in publications arising from this study, after de-identification, may be made available to qualified researchers upon reasonable request. Supporting documents, including the study protocol, may also be made available, as appropriate. Data will become available beginning 6 months following publication of the primary study results and may remain available for up to 5 years thereafter. Requests for access must include a scientifically sound research proposal and may be subject to review by the Sponsor. Data will be provided only after execution of an appropriate data sharing agreement.
Supporting information: Study protocol
Time frame: Beginning 6 months after publication of primary results and ending 5 years after publication.
Access criteria: Access available to qualified researchers with a methodologically sound proposal, subject to Sponsor review and execution of a data sharing agreement.
Data sharing details ↗ · allterum.com
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