CD45RA Depleted Stem Cell Addback for Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byTimothy Olson, MD, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Children's Hospital of Philadelphia

No Placebo Group

Trial Summary

What is the purpose of this trial?The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab/CD19 depleted PSCT.

Eligibility Criteria

This trial is for individuals up to 25 years old with conditions like primary immunodeficiency, various leukemias, bone marrow failure, and other related disorders. They should be in a state where a stem cell transplant could cure them and meet specific health standards set by the CHOP CTTS program.

Inclusion Criteria

My organs are healthy and I don't have infections.

I have taken a pregnancy test and it was negative.

My condition may be cured by a stem cell transplant from a donor.

+3 more

Participant Groups

The study tests adding back CD45RO memory T lymphocytes after depleting certain cells from donor stem cell grafts to prevent GVHD and infections post-transplant. It's determining the safest dose level that accelerates immune recovery without significant side effects.

3Treatment groups

Experimental Treatment

Group I: Phase 2:TCRab/CD19 depleted PSCT with CD45RA depleted addback using unrelated donorsExperimental Treatment1 Intervention

Stem cell source: mobilized PBSC Donor type: 9/10 or 10/10 matched unrelated donor Conditioning: disease specific SOC regimens

Group II: Phase 2:TCRab/CD19 depleted PSCT with CD45RA depleted addback at MTD found in phase 1 using MMRDExperimental Treatment1 Intervention

Stem cell source: mobilized PBSC Donor type: \> or = 5/10 mismatched related donor Conditioning: disease specific SOC regimens

Group III: Phase 1:TCRab/CD19 depleted PSCT with CD45RA depleted addback using mismatched related donors (MMRD)Experimental Treatment3 Interventions

Stem cell source: mobilized peripheral blood stem cells (PBSC) Donor type: \> or = 5/10 mismatched related donor Conditioning: disease specific standard of care (SOC) regimens