Phase I Study of Prophylactic TCRαβ+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is being done to assess the safety and determine the maximum tolerable dose (MTD) of TCRαβ+/CD19+-depleted Donor Lymphocyte Infusion (αβT/B dep-DLI) after allogeneic stem cell transplant (allo-SCT) in highrisk patients with hematologic malignancies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Patients with high-risk myeloid or lymphoid malignancies determined to be eligible to undergo a related, allo-SCT using Disease Risk Index (DRI), including the conditions listed below. These criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:

‣ Refractory acute myelogenous or lymphoid leukemia

⁃ Relapsed acute myelogenous or lymphoid leukemia

⁃ Myelodysplastic syndromes with 5 percent or more blasts

⁃ Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase

⁃ Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a partial response at transplant

⁃ High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen

⁃ Other high risk hematologic malignancies for which allo-SCT is deemed clinically necessary per PI and based on institutional standards

• The donor for the allo-SCT will have been identified prior to participant recruitment and must be:

‣ Related AND

⁃ Matched OR mismatched OR haploidentical at Human Leukocyte Antigen (HLA) HLA-A, -B, -C, and -DRB1 by molecular methods

• Eastern Cooperative Oncology Group (ECOG) performance score of 0-2

• Ability to understand and willingness to sign written informed consent document

• Willing to comply with all study procedures and be available for the duration of the study

• Individuals in sexual relationships that could result in pregnancy or impregnation of their partner must use an acceptable method of contraception§ from enrollment until 4 weeks after completing study treatment.

Locations
United States
Wisconsin
UW Carbone Cancer Center
RECRUITING
Madison
Contact Information
Primary
Cancer Connect
clinicaltrials@cancer.wisc.edu
800-622-8922
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2031-02
Participants
Target number of participants: 38
Treatments
Experimental: Dose Escalation Cohort Level 1
1 x 10\^6 CD3-CD56+/kg
Experimental: Dose Escalation Cohort Level 2
2 X 10\^6 CD3-CD56+/kg
Experimental: Dose Escalation Cohort Level 3
5 X 10\^6 CD3-CD56+/kg
Experimental: Dose Escalation Cohort Level -1
0.5 x 10\^6 CD3-CD56+/kg~Dose to be used only if Dose Level 1 is not tolerated.
Related Therapeutic Areas
Sponsors
Leads: University of Wisconsin, Madison

This content was sourced from clinicaltrials.gov

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