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STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis

Primary Purpose

Refractory T Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML)

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Part 1 (STI-6129)
Part 2 (STI-6129)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory T Acute Lymphoblastic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be enrolled in the study, patients must satisfy all inclusion criteria, as follows:

  1. Age greater than or equal to 18 years.
  2. Confirmed diagnosis of R/R T-ALL or R/R AML by bone marrow evaluation. Note that patients must have failed treatment with available therapies known to be active for treatment of their T-ALL/AML
  3. ECOG performance status of 0, 1, or 2
  4. Pulse oximetry greater than or equal to 92% on room air
  5. Be willing and able to comply with the study schedule and all other protocol requirements
  6. Females of childbearing potential (FCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative pregnancy test during the Screening Period prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective methods of birth control throughout the study

Subject Exclusion Criteria:

To be enrolled in the study, patients must not satisfy any of the following exclusion criteria:

  1. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 months or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer or in situ cancer that does not require further active treatment or is well under control
  2. Treatment with an allogeneic hematopoietic stem cell transplantation (HSCT) within 3 months prior to the planned infusion of STI-6129, or active graft-versus-host disease (GVHD) following the allogeneic transplant, or a requirement for currently receiving immunosuppressive therapy following the allogeneic transplant.
  3. Must be off calcineurin inhibitors for at least 4 weeks prior to study treatment.
  4. New York Heart Association (NYHA) class greater than or equal to 3
  5. Left ventricular ejection fraction (LVEF) < 40%.
  6. The following baseline chemistry laboratory results at Screening:

    1. Serum creatinine > 2.0 x the upper limit of normal (ULN), or estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault equation).
    2. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x the upper limit of normal (ULN) or serum total bilirubin > 1.5x ULN (except for patients in or leukemia involvement)
  7. Pregnancy or currently breastfeeding
  8. Patients with greater than Grade 3 neuropathy or Grade 2 neuropathy with associated pain
  9. Active bacterial, viral, or fungal infection at the time of the infusion of STI-6129; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents, or infection controlled on antimicrobial agents remain eligible as long as there is no evidence of active infection
  10. Uncontrolled human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBs antigen positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test.
  11. Have a prolongation in QTcF (Fridericia correction formula) > 480 msec on a baseline ECG
  12. Any condition including the presence of laboratory abnormalities that places the patient at an unacceptable risk if the patient was to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Part 1 (dose escalation)

    Part 2 (dose expansion)

    Arm Description

    Participants of the first group will receive the lowest dose level. Participants of each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of STI-6129 is found.

    Participants will receive the dose of STI-6129 found in Part 1 of the study.

    Outcomes

    Primary Outcome Measures

    Severity of the adverse events (Aes) -The severity of the adverse events (Aes) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V.5

    Secondary Outcome Measures

    Full Information

    First Posted
    August 25, 2022
    Last Updated
    August 29, 2023
    Sponsor
    M.D. Anderson Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05519527
    Brief Title
    STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis
    Official Title
    A Phase 1 Study of Safety and Efficacy of an Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory T-Acute Lymphoblastic Leukemia/Lymphoma (T-ALL) or Acute Myeloid Leukemia (AML)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    0 patient accrual
    Study Start Date
    August 16, 2022 (Actual)
    Primary Completion Date
    February 15, 2023 (Actual)
    Study Completion Date
    February 15, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    M.D. Anderson Cancer Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is an open-label, phase 1b/2 trial. It is designed to identify the recommended phase 2 dose (RP2D) of STI-6129, and the safety and efficacy of this anti-CD38-Duostatin 5.2 antibody-drug conjugate (ADC) for the treatment of R/R T-ALL and AML who have exhausted standard of care treatment.
    Detailed Description
    Primary Objective: To assess in patients with R/R T-ALL or AML Maximum tolerated dose of STI-6129 Phase 2 recommended dose Safety of STI-6129 Secondary Objectives: Efficacy of STI-6129, overall response rate (CR+CRi+MLFS) Evaluate rate of negative measurable residual disease (MRD) Evaluate overall survival, duration of response, event-free survival No. of patients transitioning to stem-cell transplantation Exploratory Objectives: - Evaluate the association of biomarkers with safety and efficacy in patients with R/R T-ALL or AML treated with STI-6129 CD38 ADC STI-6129 - R/R T-ALL, AML

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractory T Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1 (dose escalation)
    Arm Type
    Experimental
    Arm Description
    Participants of the first group will receive the lowest dose level. Participants of each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of STI-6129 is found.
    Arm Title
    Part 2 (dose expansion)
    Arm Type
    Experimental
    Arm Description
    Participants will receive the dose of STI-6129 found in Part 1 of the study.
    Intervention Type
    Drug
    Intervention Name(s)
    Part 1 (STI-6129)
    Intervention Description
    Given by vein (IV)
    Intervention Type
    Drug
    Intervention Name(s)
    Part 2 (STI-6129)
    Intervention Description
    Given by vein (IV)
    Primary Outcome Measure Information:
    Title
    Severity of the adverse events (Aes) -The severity of the adverse events (Aes) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V.5
    Time Frame
    through completion of study or an average of 1 year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be enrolled in the study, patients must satisfy all inclusion criteria, as follows: Age greater than or equal to 18 years. Confirmed diagnosis of R/R T-ALL or R/R AML by bone marrow evaluation. Note that patients must have failed treatment with available therapies known to be active for treatment of their T-ALL/AML ECOG performance status of 0, 1, or 2 Pulse oximetry greater than or equal to 92% on room air Be willing and able to comply with the study schedule and all other protocol requirements Females of childbearing potential (FCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative pregnancy test during the Screening Period prior to treatment. All heterosexually active FCBP and all heterosexually active male patients must agree to use effective methods of birth control throughout the study Subject Exclusion Criteria: To be enrolled in the study, patients must not satisfy any of the following exclusion criteria: A diagnosis of other malignancies if the malignancy has required therapy within the last 3 months or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer or in situ cancer that does not require further active treatment or is well under control Treatment with an allogeneic hematopoietic stem cell transplantation (HSCT) within 3 months prior to the planned infusion of STI-6129, or active graft-versus-host disease (GVHD) following the allogeneic transplant, or a requirement for currently receiving immunosuppressive therapy following the allogeneic transplant. Must be off calcineurin inhibitors for at least 4 weeks prior to study treatment. New York Heart Association (NYHA) class greater than or equal to 3 Left ventricular ejection fraction (LVEF) < 40%. The following baseline chemistry laboratory results at Screening: Serum creatinine > 2.0 x the upper limit of normal (ULN), or estimated creatinine clearance < 60 mL/min (using the Cockcroft-Gault equation). Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3x the upper limit of normal (ULN) or serum total bilirubin > 1.5x ULN (except for patients in or leukemia involvement) Pregnancy or currently breastfeeding Patients with greater than Grade 3 neuropathy or Grade 2 neuropathy with associated pain Active bacterial, viral, or fungal infection at the time of the infusion of STI-6129; patients with ongoing use of prophylactic antibiotics, antifungal agents, or antiviral agents, or infection controlled on antimicrobial agents remain eligible as long as there is no evidence of active infection Uncontrolled human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBs antigen positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test. Have a prolongation in QTcF (Fridericia correction formula) > 480 msec on a baseline ECG Any condition including the presence of laboratory abnormalities that places the patient at an unacceptable risk if the patient was to participate in the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Abhishek Maiti, MBBS
    Organizational Affiliation
    amaiti@mdanderson.org
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.mdanderson.org
    Description
    M D Anderson Cancer Center

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    STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis

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