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)
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Shibani M Kudchadkar, MD
- 전화번호: 15153439875
- 이메일: skudchadkar@allterum.com
연구 연락처 백업
- 이름: Yan Moore, MD, MBA
- 전화번호: 6178004959
- 이메일: ymoore@allterum.com
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80045
- 모병
- Children's Hospital Colorado
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연락하다:
- Kelly Faulk, MD
- 전화번호: (720)777-6740
- 이메일: Kelly.Faulk@childrenscolorado.org
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Indiana
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Indianapolis, Indiana, 미국, 46202
- 모병
- Riley Children's Hosptial
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수석 연구원:
- Sandeep Batra, MD
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연락하다:
- Sara Quentant
- 전화번호: 317-948-3395
- 이메일: squentant@iu.edu
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New York
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New York, New York, 미국, 10065
- 모병
- Memorial Sloan Kettering Cancer Center
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수석 연구원:
- Maria Luisa Sulis, MD
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연락하다:
- Juliette Wiseman Site Contact
- 전화번호: 855-762-0678
- 이메일: wisemanj@mskcc.org
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Ohio
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Cincinnati, Ohio, 미국, 45229
- 아직 모집하지 않음
- Cincinnati Children's Hospital Medical Center
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연락하다:
- Lori Backus
- 전화번호: 513-636-2047
- 이메일: lori.backus@cchmc.org
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수석 연구원:
- Lauren Pommert, MD
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 아직 모집하지 않음
- Children's Hospital of Philadelphia
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연락하다:
- Susan Rheingold, MD
- 전화번호: (267) 426-0762
- 이메일: rheingold@chop.edu
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Texas
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Fort Worth, Texas, 미국, 76104
- 모병
- Cook Children's Medical Center
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수석 연구원:
- Holly Pacenta, MD
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연락하다:
- Heather Jernigan
- 전화번호: 682-885-2103
- 이메일: Heather.Jernigan@cookchildrens.org
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연락하다:
- Andrea Martinez
- 전화번호: 682-303-3061
- 이메일: andrea.martinez@cookchildrens.org
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Houston, Texas, 미국, 77030
- 모병
- Texas Children's Hospital
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연락하다:
- Eric Schafer, MD
- 전화번호: (832) 822-3300
- 이메일: esschafe@texaschildrens.org
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Key Inclusion Criteria:
- Confirmed diagnosis of T/B-ALL or T/B-LL
- Relapsed or refractory disease without curative options
- Adequate organ function and performance status
Key Exclusion Criteria:
- Patients with CNS3 disease
- Patients with DNA fragility syndromes (e.g., Fanconi, Bloom), trisomy 21 (Down Syndrome)
- Prior exposure to anti-CD127 therapies
- Uncontrolled infections
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events (TEAEs) at each dose level
기간: Through study duration, an average of 1 year
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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.
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Through study duration, an average of 1 year
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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.
기간: Through study duration, an average of 1 year
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Determination of the RP2D/RDE of ALT-101 based on evaluation of safety, tolerability, and available pharmacokinetic and pharmacodynamic data following dose-escalation.
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Through study duration, an average of 1 year
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
기간: Through study duration, an average of 1 year
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Complete Remission (CR) Rate Percentage of participants who achieve Complete Remission (CR) according to standardized disease response criteria.
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Through study duration, an average of 1 year
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Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
기간: Through study duration, an average of 1 year
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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
|
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Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
기간: Through study duration, an average of 1 year
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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
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Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
기간: Through the study duration, an average of 1 year.
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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.
|
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Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
기간: 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
|
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Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
기간: Through the study duration, an average of 1 year
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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
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Determine the Pharmacokinetics of 4A10 as a single agent in patients with Relapsed/Refractory ALL/LL.
기간: Through the study duration, an average of 1 year
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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
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
기간: Through study duration, an average of 1 year.
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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.
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Through study duration, an average of 1 year.
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
기간: Through study duration, an average of 1 year
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Measurable Residual Disease (MRD) Negativity Rate Percentage of participants achieving MRD-negative status among participants who achieve CR or CRi.
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Through study duration, an average of 1 year
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
기간: Through study duration, an average of 1 year
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Duration of Response (DOR) Time from first documented CR or CRi to disease relapse, progression, or death from any cause, whichever occurs first.
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Through study duration, an average of 1 year
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
기간: Through study duration, an average of 1 year
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Time to Response (TTR) Time from initiation of study treatment to first documented achievement of CR or CRi.
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Through study duration, an average of 1 year
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
기간: Through study duration, an average of 1 year
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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
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL.
기간: Through the study duration, an average of 1 year
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Time to Progression (TTP) Time from initiation of study treatment to documented disease progression.
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Through the study duration, an average of 1 year
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL
기간: Through study duration, an average of 1 year
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Overall Survival (OS) Time from initiation of study treatment to death from any cause.
|
Through study duration, an average of 1 year
|
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL
기간: Through study duration, an average of 1 year
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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
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Preliminary anti-tumor activity of 4A10 as a single agent in patients with refractory/ relapsed ALL or LL
기간: Through study duration, an average of 1 year
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Transfusion Independence Rate Percentage of participants achieving transfusion independence during study treatment and follow-up.
|
Through study duration, an average of 1 year
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공동 작업자 및 조사자
수사관
- 연구 의자: Eric Schafer, MD, Baylor College of Medicine
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- The ALLiance Study
- 5R44CA268530-02 (미국 NIH 보조금/계약)
- DP230071 (기타 보조금/기금 번호: Cancer Prevention and Research Institute of Texas (CPRIT))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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