XmAb18968 for Leukemia

Recruiting at 5 trial locations

Overseen By Medical College of Wisconsin Cancer Center Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ehab L Atallah

Must not be taking: Anti-CD38 antibodies

Disqualifiers: Acute promyelocytic leukemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase 1, dose-escalation study (using 3 + 3 dose-limiting toxicity (DLT) criteria) evaluating the safety and tolerability of XmAb18968, as well as establishing a recommended phase II dose (RP2D) in subjects with T cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic (lymphoma) T-LBL (Group A) and acute myeloid leukemia (AML) (Group B).

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

I meet the menopause or birth control requirements.

My leukemia is in a relapsed or unresponsive state with measurable signs.

My liver, kidneys, and heart are functioning well, and I can care for myself.

Exclusion Criteria

I do not have any serious illnesses that could affect my participation.

I have recently had cancer treatment or taken specific cancer drugs.

I agree not to donate sperm during the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Dose-escalation study using 3 + 3 dose-limiting toxicity criteria to evaluate safety and tolerability of XmAb18968

28 days per cycle

Multiple visits per cycle for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

What Are the Treatments Tested in This Trial?

Interventions

• XmAb18968

Trial Overview The trial is testing different doses of XmAb18968 in patients with specific types of blood cancers. It's a phase 1 study that gradually increases the dose to find the safest and most effective level for future studies.

How Is the Trial Designed?

Group I: Arm Z: Dose Level -1 for Group A (T-ALL, T-LBL) Experimental Treatment 1 Intervention

0.1 mg intravenous (IV) Cycle (C) 1 Day (D) 1, 0.3 mg IV C1D2, then 0.4 mg IV on D8, D15, and D22 in a 28-day cycle.

Group II: Arm Z: Dose Level -1 Group B (AML) Experimental Treatment 1 Intervention

0.1 mg IV C1D1, 0.3 mg IV C1D2, then 0.4 mg IV on D8, D15, and D22 in a 28-day cycle.

Group III: Arm D: Dose Level 3 Group B (AML) Experimental Treatment 1 Intervention

0.5 mg IV C1D1, 1.0 mg IV C1D2, then 1.5 mg IV on D8, D15, and D22 in a 28-day cycle.

Group IV: Arm D: Dose Level 3 Group A (T-ALL, T-LBL) Experimental Treatment 1 Intervention

0.5 mg IV C1D1, 1.0 mg IV C1D2, then 1.5 mg IV on D8, D15, and D22 in a 28-day cycle.

Group V: Arm C: Dose Level 2 Group B (AML) Experimental Treatment 1 Intervention

0.4 mg IV C1D1, 0.9 mg IV C1D2, then 1.3 mg IV on D8, D15, and D22 in a 28-day cycle.

Group VI: Arm C: Dose Level 2 Group A (T-ALL, T-LBL) Experimental Treatment 1 Intervention

0.4 mg IV C1D1, 0.9 mg IV C1D2, then 1.3 mg IV on D8, D15, and D22 in a 28-day cycle.

Group VII: Arm B: Dose Level 1 for Group A (T-ALL, T-LBL) Experimental Treatment 1 Intervention

0.25 mg IV C1D1, 0.75 mg IV C1D2, then 1.0 mg IV on D8, D15, and D22 in a 28-day cycle.

Group VIII: Arm B: Dose Level 1 Group B (AML) Experimental Treatment 1 Intervention

0.25 mg IV C1D1, 0.75 mg IV C1D2, then 1.0 mg IV on D8, D15, and D22 in a 28-day cycle.

Group IX: Arm A: Dose Level 0 (Starting Dose) for Group A (T-ALL, T-LBL) Experimental Treatment 1 Intervention

0.2 mg IV C1D1, 0.6 mg IV C1D2, then 0.8 mg IV on D8, D15, and D22 in a 28-day cycle.

Group X: Arm A: Dose Level 0 (Starting Dose) Group B (AML) Experimental Treatment 1 Intervention

0.2 mg IV C1D1, 0.6 mg IV C1D2, then 0.8 mg IV on D8, D15, and D22 in a 28-day cycle.

Who Is Running the Clinical Trial?

Ehab L Atallah

Lead Sponsor

Trials

4

Recruited

50+