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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. (ALT-101)

31. august 2026 oppdatert av: Allterum Therapeutics, Inc

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

24

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Rekruttering
        • Riley Children's Hosptial
        • Hovedetterforsker:
          • Sandeep Batra, MD
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10065
        • Rekruttering
        • Memorial Sloan Kettering Cancer Center
        • Hovedetterforsker:
          • Maria Luisa Sulis, MD
        • Ta kontakt med:
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45229
        • Har ikke rekruttert ennå
        • Cincinnati Children's Hospital Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Lauren Pommert, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • Har ikke rekruttert ennå
        • Children's Hospital of Philadelphia
        • Ta kontakt med:
    • Texas
      • Fort Worth, Texas, Forente stater, 76104
      • Houston, Texas, Forente stater, 77030
        • Rekruttering
        • Texas Children's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Key Inclusion Criteria:

  1. Confirmed diagnosis of T/B-ALL or T/B-LL
  2. Relapsed or refractory disease without curative options
  3. Adequate organ function and performance status

Key Exclusion Criteria:

  1. Patients with CNS3 disease
  2. Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)
  3. Prior exposure to anti-CD127 therapies
  4. Uncontrolled infections

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level
Tidsramme: 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.
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.
Tidsramme: 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.
Through study duration, an average of 1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
Tidsramme: 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.
Through study duration, an average of 1 year
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
Tidsramme: 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.
Through study duration, an average of 1 year
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
Tidsramme: 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.
Through study duration, an average of 1 year
Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
Tidsramme: 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.
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.
Tidsramme: 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.
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.
Tidsramme: 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.
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.
Tidsramme: 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.
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.
Tidsramme: 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.
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.
Tidsramme: 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.
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.
Tidsramme: 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.
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.
Tidsramme: 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.
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.
Tidsramme: 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.
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.
Tidsramme: Through the study duration, an average of 1 year
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
Tidsramme: Through study duration, an average of 1 year
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
Tidsramme: 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.
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
Tidsramme: Through study duration, an average of 1 year
Transfusion Independence Rate Percentage of participants achieving transfusion independence during study treatment and follow-up.
Through study duration, an average of 1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Allterum Therapeutics, Inc

Samarbeidspartnere

National Cancer Institute (NCI)
Cancer Prevention Research Institute of Texas

Etterforskere

  • Studiestol: Eric Schafer, MD, Baylor College of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2026

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. september 2028

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • The ALLiance Study
  • 5R44CA268530-02 (U.S. NIH-stipend/kontrakt)
  • DP230071 (Annet stipend/finansieringsnummer: Cancer Prevention and Research Institute of Texas (CPRIT))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 6 months after publication of primary results and ending 5 years after publication.

Tilgangskriterier for IPD-deling

Access available to qualified researchers with a methodologically sound proposal, subject to Sponsor review and execution of a data sharing agreement.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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