Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 21, 2025

Primary Completion Date

March 31, 2031

Study Completion Date

March 31, 2032

Conditions
LeukemiaHigh Risk Acute Lymphoblastic LeukemiaHigh Risk Acute Myeloid LeukemiaRelapse LeukemiaMDS (Myelodysplastic Syndrome)Relapsed Non-Hodgkin LymphomaAcquired Aplastic AnemiaInherited BMF SyndromeImmunodeficiencyPrimary Immune Regulatory DisorderHemoglobinopathiesBone Marrow FailureInborn Errors of MetabolismHLH
Interventions
DEVICE

Phase 1 Dose Level 1

Patients in the first dose level for the CD45RA depleted addback will receive 1 X 10\^6 CD45RO+ T cells/kg. Once all patients in this dose group have been evaluated for acute GVHD at day 100, then we will advance to the next dose level if indicated by safety analysis.

DEVICE

Phase 1 Dose Level 2

Patients in the second dose level for the CD45RA depleted addback will receive 2 X 10\^6 CD45RO+ T cells/kg. Once all patients in this dose group have been evaluated for acute GVHD at day 100, then we will advance to the next dose level if indicated by safety analysis.

DEVICE

Phase 1 Dose Level 3

"Patients in the third and final dose level for the CD45RA depleted addback will receive 5 X 10\^6 CD45RO+ T cells/kg. All patients in this dose group will be evaluated for acute GVHD at day 100. Based on these findings, the maximum tolerated dose (MTD) will be determined.~Once MTD for the addback cell dose has been determined in Phase 1, subjects with mismatched related donors will then enroll in Phase 2."

DEVICE

Phase 2 Maximum Tolerated Dose determined in Phase 1

Patients with mismatched related donors will receive the CD45RA depleted addback at the maximum tolerated dose determined in the Phase 1 portion of the study.

DEVICE

Phase 2 Established Dose from prior study, NCT03810196

Patients with unrelated donors will receive the CD45RA depleted addback at the dose 5 X 10\^6 CD45RO+ T cells.

Trial Locations (1)

19104

RECRUITING

Children's Hospital of Philadelphia, Philadelphia

All Listed Sponsors
lead

Children's Hospital of Philadelphia

OTHER