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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 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

24

Estágio

  • Fase 1

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Recrutamento
        • Riley Children's Hosptial
        • Investigador principal:
          • Sandeep Batra, MD
        • Contato:
    • New York
      • New York, New York, Estados Unidos, 10065
        • Recrutamento
        • Memorial Sloan Kettering Cancer Center
        • Investigador principal:
          • Maria Luisa Sulis, MD
        • Contato:
          • Juliette Wiseman Site Contact
          • Número de telefone: 855-762-0678
          • E-mail: wisemanj@mskcc.org
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45229
        • Ainda não está recrutando
        • Cincinnati Children's Hospital Medical Center
        • Contato:
        • Investigador principal:
          • Lauren Pommert, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Ainda não está recrutando
        • Children's Hospital of Philadelphia
        • Contato:
    • Texas
      • Fort Worth, Texas, Estados Unidos, 76104
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • Texas Children's Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level
Prazo: 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.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Allterum Therapeutics, Inc

Colaboradores

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

Investigadores

  • Cadeira de estudo: Eric Schafer, MD, Baylor College of Medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de maio de 2028

Conclusão do estudo (Estimado)

1 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

22 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • The ALLiance Study
  • 5R44CA268530-02 (Concessão/Contrato do NIH dos EUA)
  • DP230071 (Número de outro subsídio/financiamento: Cancer Prevention and Research Institute of Texas (CPRIT))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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