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Refractory B-cell Acute Lymphoblastic LeukemiaPhase 1NCT05961696

A Phase I Study of Mosunetuzumab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

A Phase 1 study testing Mosunetuzumab in people with Refractory B-cell Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To find a recommended dose of mosunetuzumab that can be given to patients with ALL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Mosunetuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
5 Jul 2023to 3 Oct 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

  • Patients must meet the following criteria for study entry:
  • Signed Informed Consent Form
  • Age 18 years at the time of signing Informed Consent Form
  • Ability to comply with the study protocol
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Histologically confirmed relpased and/or refractory B-ALL with ≥5% marrow blasts or marrow MRD+ (≥0.1%) disease. At least 50% of the blasts must express CD20. Relapsed disease is defined as disease relapse after achieving an initial response to prior therapies. For patients in 1st relapse of their disease, those with CR1 duration >12 months are excluded. Refractory disease is defined as disease refractory to the last therapy received. All patients must have failed or ineligible to receive all therapies with clinical benefit.
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  • Adequate organ function:
  • Measured or estimated creatinine clearance 50 mL/min by institutional standard method
  • AST or ALT 2.5 the upper limit of normal (ULN)
  • Serum total bilirubin 1.5 ULN (or 3 ULN for patients with Gilbert syndrome)
  • Ejection fraction ≥50%
  • Adequate BM function independent of growth factor or transfusion support, within 2 weeks of screening, unless cytopenia is clearly due to marrow involvement of B-ALL:
  • Platelet count ≥50,000/mm3
  • ANC ≥500/mm3
  • Hemoglobin ≥9 g/dL
  • WBC ≤10 K/µL at Cycle 1 Day 1
  • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use 2 adequate methods of contraception, including at least 1 method with a failure rate of 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), 90 days after the final dose mosunetuzumab. Women must refrain from donating eggs during this same period.
  • A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state ( 24 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Even in presence of infertility history, a reliable contraception, including 2 adequate methods of contraception, is indicated.
  • Examples of non-hormonal contraceptive methods with a failure rate of 1% per year include bilateral tubal ligation, male sterilization, established and proper use of progestogen only hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices. Barrier methods must always be supplemented with the use of a spermicide.
  • For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below:
  • With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of mosunetuzumab. Men must refrain from donating sperm during this same period.

Who cannot join

  • Patients who meet any of the following criteria will be excluded from study entry:
  • Active CNS disease. Previous history of CNS disease is allowed as long as last documented CNS positivity is >3 months ago, and the last 2 LP are negative for CNS leukemia.
  • Prior standard or investigational anti cancer therapy as specified below:
  • Chimeric antigen receptor T cell therapy within 30 days prior to Day 1 of Cycle 1
  • Monoclonal antibody or antibody drug conjugate within 4 weeks prior to Cycle 1 Day 1
  • Treatment with any anti cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
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  • Note: For urgent cytoreduction, steroids and hydroxyurea are permitted up to 2 days prior to Cycle 1 Day 1.
  • Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade 1 (per NCI CTCAE, v5.0) prior to Day 1 of Cycle 1
  • Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone ( 20 mg) within 2 weeks prior to Day 1 of Cycle 1
  • The use of inhaled corticosteroids is permitted
  • The use of mineralocorticoids for management of orthostatic hypotension is permitted
  • Single dose of dexamethasone for nausea or B symptoms is permitted
  • Use of steroids for cytoreduction is permitted as per criteria above
  • History of solid organ transplantation
  • History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies (MAbs)
  • Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab, lenalidomide, or thalidomide formulation, including mannitol
  • History of erythema multiforme, Grade 3 rash, or blistering following prior treatment with immunomodulatory derivatives
  • Active uncontrolled bacterial, viral, fungal, or other infection
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
  • Active Hepatitis B infection
  • Patients who are hepatitis B surface antigen (HBsAg) negative and hepatitis B core antibody (HBcAb) positive, must be negative for hepatitis B virus (HBV) polymerase chain reaction (PCR) to be eligible for study participation
  • Active Hepatitis C infection
  • Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by PCR to be eligible for study participation
  • Known history of human immunodeficiency virus (HIV) positive status
  • For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations
  • History of progressive multifocal leukoencephalopathy (PML)
  • Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment
  • Other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following:
  • Any of the following malignancies previously curatively treated: carcinoma in situ of the cervix, good-prognosis ductal carcinoma in situ of the breast, basal, or squamous cell skin cancer
  • Stage I melanoma, low grade, early stage localized prostate cancer, or any other previously treated malignancy that has been in remission without treatment for 2 years prior to enrollment
  • Active autoimmune disease requiring treatment
  • History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
  • Patients with a remote history of, or well-controlled autoimmune disease, with a treatment free interval from immunosuppressive therapy for 12 months may be eligible to enroll if judged to be safe by the investigator
  • Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone are eligible
  • Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
  • Patients with a history of disease-related immune thrombocytopenic purpura, or autoimmune hemolytic anemia may be eligible
  • Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
  • Major surgical procedure within 28 days prior to Day 1 of Cycle 1
  • Pregnant or lactating or intending to become pregnant during the study Women of childbearing potential must have negative serum/urine pregnancy test within 14 days prior to initiating therapy
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

To find a recommended dose of mosunetuzumab that can be given to patients with ALL.

Read the detailed description

Primary Objectives:

--To assess the safety of mosunetuzumab in patients with R/R B-ALL

Secondary Objectives:

--To assess rate of CR/CRi, duration of response (DOR), progression-free survival (PFS) and overall survival (OS) of mosunetuzumab in patients with R/R B-ALL

Being tested
Mosunetuzumab
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MosunetuzumabDrug

    Also called RO7030816

    Subcutaneous (SQ or Sub-Q) injection under the skin

Study groups in NCT05961696
Study groupRoleWhat they receive
MosunetuzumabExperimentalParticipants will be assigned to a dose level of mosunetuzumab based on when the participants join this study. Up to 2 dose levels of mosunetuzumab will be tested. The first group of participants will receive the lowest dose level. A second group will receive a higher dose than the group before it, if no intolerable side effects were seen.
Receives: Drug: Mosunetuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: through study completion; 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.

  1. First posted27 Jul 2023
  2. Study start5 Jul 2023
  3. Primary completion3 Oct 2023
  4. Study completion3 Oct 2023

Why it stopped: 0 accrual

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05961696
Sponsor's protocol ID
2022-0530
Other IDs
NCI-2023-05744
Status last verified
Oct 2023
First submitted
18 Jul 2023
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mosunetuzumab in people with Refractory B-cell Acute Lymphoblastic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

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 21 inclusion and 42 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; 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?

On the ClinicalTrials.gov record for NCT05961696.

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 10 Oct 2023.

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