XmAb18968 for Leukemia
Recruiting at 5 trial locations
MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Ehab L Atallah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
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).
Research Team
Ehab L. Atallah
Principal Investigator
Medical College of Wisconsin
Eligibility Criteria
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.
See 3 more
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.
See 15 more
Timeline
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
Treatment Details
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.
Participant Groups
10Treatment groups
Experimental Treatment
Group I: Arm Z: Dose Level -1 for Group A (T-ALL, T-LBL)Experimental Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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 Treatment1 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ehab L Atallah
Lead Sponsor
Trials
4
Recruited
50+
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