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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)

2026年8月31日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

介入

入学 (推定)

24

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Colorado
      • Aurora、Colorado、アメリカ、80045
    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
        • 募集
        • Riley Children's Hosptial
        • 主任研究者：
          • Sandeep Batra, MD
        • コンタクト：
    • New York
      • New York、New York、アメリカ、10065
        • 募集
        • Memorial Sloan Kettering Cancer Center
        • 主任研究者：
          • Maria Luisa Sulis, MD
        • コンタクト：
          • Juliette Wiseman Site Contact
          • 電話番号：855-762-0678
          • メール：wisemanj@mskcc.org
    • Ohio
      • Cincinnati、Ohio、アメリカ、45229
        • まだ募集していません
        • Cincinnati Children's Hospital Medical Center
        • コンタクト：
        • 主任研究者：
          • Lauren Pommert, MD
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • まだ募集していません
        • Children's Hospital of Philadelphia
        • コンタクト：
    • Texas
      • Fort Worth、Texas、アメリカ、76104
      • Houston、Texas、アメリカ、77030
        • 募集
        • Texas Children's Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level
時間枠：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.
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Allterum Therapeutics, Inc

協力者

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

捜査官

  • スタディチェア：Eric Schafer, MD、Baylor College of Medicine

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月1日

一次修了 (推定)

2028年5月1日

研究の完了 (推定)

2028年9月1日

試験登録日

最初に提出

2026年4月22日

QC基準を満たした最初の提出物

2026年5月8日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月1日

QC基準を満たした最後の更新が送信されました

2026年8月31日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • The ALLiance Study
  • 5R44CA268530-02 (米国 NIH グラント/契約)
  • DP230071 (その他の助成金/資金番号：Cancer Prevention and Research Institute of Texas (CPRIT))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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