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Monoclonal Antibodies

XmAb18968 for Leukemia

Phase 1
Recruiting
Led By Ehab Atallah, MD
Research Sponsored by Ehab L Atallah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Morphologically documented T-ALL, AML (including undifferentiated leukemia and bi-phenotypic leukemia, or T-LBL in relapsed/refractory status with measurable residual disease by flow cytometry, molecular testing or cytogenetics
CD38 expression ≥ 20% by flow cytometry or immunohistochemistry at time of relapse
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new drug for safety and side effects in patients with leukemia. The goal is to find the best dose to use in future trials.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions related to immune therapies such as infusion reactions, fatigue, fever, allergic responses, and possible impacts on normal blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia is in a relapsed or unresponsive state with measurable signs.
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My cancer cells show high CD38 levels at relapse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended Phase 2 Dose for Group A
Recommended Phase 2 Dose for Group B
The number of dose-limiting toxicities for group A level -1
+9 more
Secondary outcome measures
Event-free survival (EFS) in group A
Event-free survival (EFS) in group B
Overall survival in group A
+20 more

Trial Design

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 Location

Who is running the clinical trial?

Ehab L AtallahLead Sponsor
3 Previous Clinical Trials
28 Total Patients Enrolled
Ehab Atallah, MDPrincipal InvestigatorMedical College of Wisconsin
9 Previous Clinical Trials
658 Total Patients Enrolled

Media Library

XmAb18968 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05038644 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals does this exploration seek to accomplish?

"The chief goal of this four-year trial is to monitor the number of dose-limiting toxicities for group A level 0. Secondary objectives include examining complete response with incomplete hematological recovery in group A level 1, starting dose, and -1 respectively; each defined by absolute neutrophil count (ANC) or platelet count measures."

Answered by AI

How many participants are being monitored in this clinical investigation?

"Affirmative. According to clinicaltrials.gov, this ongoing trial—which was first published on February 2nd 2022—is looking for 60 willing participants between 4 different medical sites."

Answered by AI

Are any slots still available for participation in this research?

"Affirmative. Information available through clinicaltrials.gov attests to the active recruitment of participants for this medical experiment, which was first advertised on February 2nd 2022 and last updated on September 28th 2022. The trial is currently in need of 60 patients from 4 separate research centres."

Answered by AI

To what extent is this clinical trial being implemented at various sites?

"Currently, 4 sites are actively conducting this medical trial - located in Phoenix, Portland and Milwaukee as well as another undisclosed location. Choosing the nearest site will reduce any associated travel expenses for participants."

Answered by AI

Could you outline the potential risk factors associated with XmAb18968 at dose level 2?

"Our judgement at Power yields a score of 1 for XmAb18968 - Dose Level 2's safety, as this is an early Phase 1 trial that has not gathered sufficient evidence to verify its efficacy and security."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
XmAb18968 (CD3-CD38) in Relapsed or Refractory Acute Leukemia and T Cell Lymphoblastic Leukemia
Ehab L Atallah 2022. "XmAb18968 (CD3-CD38) in Relapsed or Refractory Acute Leukemia and T Cell Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05038644.
~24 spots leftby Oct 2025
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