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

Conditions

• Refractory B-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mosunetuzumab — DRUG
  Subcutaneous (SQ or Sub-Q) injection under the skin

Study Details

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

Key Dates

Start date

Jul 5, 2023

Status verified

Oct 2023

Primary completion

Oct 3, 2023

Completion

Oct 3, 2023

Study Design

Enrollment

0 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Mosunetuzumab
  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.

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 ]

Locations (1)

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