Refractory T Acute Lymphoblastic LeukemiaPhase 1NCT05519527
STI-6129 CD38 ADC for the Treatment of Patients With Relapsed or Refractory Systemic ALL Amyloidosis
A Phase 1 study testing Part 1 (STI-6129) and Part 2 (STI-6129) in people with Refractory T Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia (AML), run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory T Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML)
- What is being tested?
- Part 1 (STI-6129) and Part 2 (STI-6129)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 16 Aug 2022to 15 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
About this study
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)
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.
Read the 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
- Being tested
- Part 1 (STI-6129), Part 2 (STI-6129)
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1 (STI-6129)Drug
Given by vein (IV)
Part 2 (STI-6129)Drug
Given by vein (IV)
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (dose escalation) | Experimental | 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. Receives: Drug: Part 1 (STI-6129); Drug: Part 2 (STI-6129) |
| Part 2 (dose expansion) | Experimental | Participants will receive the dose of STI-6129 found in Part 1 of the study. Receives: Drug: Part 1 (STI-6129); Drug: Part 2 (STI-6129) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through completion of study or an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start16 Aug 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Why it stopped: 0 patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory T Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Maiti, MBBS, Principal investigator, amaiti@mdanderson.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05519527
- Sponsor's protocol ID
- 2022-0113
- Other IDs
- NCI-2022-07295
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05519527
- Acronym / sponsor ID
- 2022-0113
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 0 patient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 29 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (dose escalation) | Experimental | Drug: Part 1 (STI-6129), Drug: Part 2 (STI-6129)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. |
| Part 2 (dose expansion) | Experimental | Drug: Part 1 (STI-6129), Drug: Part 2 (STI-6129)Participants will receive the dose of STI-6129 found in Part 1 of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1 (STI-6129)Given by vein (IV) | Drug | Part 1 (dose escalation), Part 2 (dose expansion) |
| Part 2 (STI-6129)Given by vein (IV) | Drug | Part 1 (dose escalation), Part 2 (dose expansion) |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhishek Maiti, MBBS principal investigator
amaiti@mdanderson.org
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Part 1 (STI-6129) and Part 2 (STI-6129) in people with Refractory T Acute Lymphoblastic Leukemia and Acute Myeloid Leukemia (AML), run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.