Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5R44CA268530-02 | U.S. NIH Grant/Contract | View source | |
| DP230071 | Other Grant/Funding Number | Cancer Prevention and Research Institute of Texas (CPRIT) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Cancer Prevention Research Institute of Texas | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4A10 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Through study duration, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study duration, an average of 1 year |
| Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shibani M Kudchadkar, MD | Contact | 15153439875 | skudchadkar@allterum.com | |
| Yan Moore, MD, MBA | Contact | 6178004959 | ymoore@allterum.com |
| Name | Affiliation | Role |
|---|---|---|
| Eric Schafer, MD | Baylor College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Not yet recruiting | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Through study duration, an average of 1 year |
| Children's Hospital of Philadelphia | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
|
| Cook Children's Medical Center | Recruiting | Fort Worth | Texas | 76104 | United States |
|
| Texas Children's Hospital | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007938 | Leukemia |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided