XmAb18968 for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new treatment called XmAb18968 for individuals with certain types of leukemia, specifically T cell acute lymphoblastic leukemia (T-ALL), T cell lymphoblastic lymphoma (T-LBL), and acute myeloid leukemia (AML). The researchers aim to find a suitable dose for future studies while ensuring the treatment's safe use. Participants with these specific types of leukemia who have relapsed or not responded to previous treatments may be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications to join the trial?
The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that you should not have had systemic cancer treatment recently, except for certain medications like hydroxyurea, steroids, or vincristine, which are allowed for reducing white blood cell counts.
Is there any evidence suggesting that XmAb18968 is likely to be safe for humans?
Research shows that XmAb18968 is a new treatment under development for certain types of leukemia and lymphoma. This drug is a CD38-CD3 bispecific antibody, targeting specific proteins on cancer cells to help the immune system attack them.
Early studies have found XmAb18968 to be safe at the starting dose, with participants tolerating it well without severe side effects. Researchers are examining its effects on individuals with T-cell acute lymphoblastic leukemia (T-ALL), T-cell lymphoblastic lymphoma (T-LBL), and acute myeloid leukemia (AML). They focus on how the body processes the drug and potential side effects.
As this study is in the first phase, it primarily tests safety. This phase typically involves small groups to determine the right dose with the fewest side effects. If well-tolerated, the drug could progress to larger studies with more participants.
For those considering joining this study, the goal is to ensure safety and find the optimal dose.12345Why are researchers excited about this trial's treatment for leukemia?
Researchers are excited about XmAb18968 because it represents a novel approach in treating leukemia, specifically T-cell acute lymphoblastic leukemia (T-ALL), T-cell lymphoblastic lymphoma (T-LBL), and acute myeloid leukemia (AML). Unlike the standard chemotherapy treatments, XmAb18968 is an engineered antibody that targets specific proteins on cancer cells, potentially offering more precise treatment with fewer side effects. This targeted mechanism of action could lead to improved outcomes and a better quality of life for patients, as it aims to directly attack cancer cells while sparing healthy ones. Additionally, the flexibility of dosing levels explored in the trial could help in optimizing the balance between efficacy and safety for different patient groups.
What evidence suggests that this trial's treatments could be effective?
In previous studies, XmAb18968 showed promise in treating T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). This trial will evaluate XmAb18968 across various treatment arms, each with different dosage levels for these conditions. The treatment targets a protein called CD38 on cancer cells, aiding the immune system in attacking them. Research indicates that XmAb18968 has effectively reduced measurable residual disease (MRD), a sign that cancer remains, in patients with these conditions. For acute myeloid leukemia (AML), findings suggest XmAb18968 is safe and can lead to remission in some cases. This trial will also test different dosage levels of XmAb18968 for AML. Overall, early evidence shows that XmAb18968 could be a beneficial treatment for these types of leukemia.12367
Who Is on the Research Team?
Ehab L. Atallah
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
Adults with relapsed or refractory T-cell acute lymphoblastic leukemia, T-cell lymphoblastic lymphoma, or acute myeloid leukemia who have had at least one prior therapy. Participants must have CD38 expression on their cancer cells and adequate organ function. They should not be pregnant or breastfeeding and must agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Dose-escalation study using 3 + 3 dose-limiting toxicity criteria to evaluate safety and tolerability of XmAb18968
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- XmAb18968
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ehab L Atallah
Lead Sponsor