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

NCT05961696 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: 2022-0530NCI-2023-05744
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractory B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

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

  through study completion; an average of 1 year

Study Arms (1)

Mosunetuzumab

EXPERIMENTAL

Participants 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.

Drug: Mosunetuzumab

Interventions

Mosunetuzumab DRUG

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

Also known as: RO7030816

Mosunetuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Nitin Jain, MBBS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 27, 2023
• Study Start: July 5, 2023
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

US (1)