M-2018-334 in Hematological Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
Miltenyi Biomedicine GmbH
Study ID
NCT06225050
Status
Recruiting
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Conditions

  • Hematological Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) — DEVICE
    PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)

Study Details

This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.

Key Dates

First listed
Jan 25, 2024
Start date
Aug 21, 2026
Status verified
Sep 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HSC Recipient
    PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)

Primary Outcome Measure

Incidence of severe acute GVHD (aGVHD) till Day 100 [ Time Frame: 100 days after haploidentical hematopoietic cell transplantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-

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By research site
City of Hope· Duarte, CA

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