WT1-specific T Cells for Multiple Myeloma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Active infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the safety of special white blood cells from a donor that are trained to attack a protein made by multiple myeloma cancer cells. The goal is to see if these cells can effectively kill the cancer cells and understand their effects on patients.

Research Team

Sergio Giralt, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults aged 21-73 with relapsed multiple myeloma post-autologous stem cell transplant or plasma cell leukemia at diagnosis. Participants need a matched donor for T-cell depleted stem cell transplant, good organ function, and a performance status >70%. Pregnant women, those with active infections or other malignancies not in remission, HIV/HTLV-positive individuals, and those allergic to mouse proteins or chicken eggs are excluded.

Inclusion Criteria

My heart, liver, kidneys, and lungs are all functioning well.

My gender or ethnic background does not limit my participation.

My multiple myeloma has returned or didn't respond after a stem cell transplant.

Exclusion Criteria

You have tested positive for HIV or HTLV.

I have had cancer before that is not currently in remission.

I am not pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparative Regimen and Transplantation

Patients undergo a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), followed by a T cell depleted stem cell transplant from a histocompatible donor.

3-4 weeks

WT1-specific T Cell Infusion

Administration of WT1-specific cytotoxic T cells post transplantation to induce complete remissions and decrease relapse rate.

3 weeks

Follow-up

Participants are monitored for safety, effectiveness, and serologic responses after treatment, including toxicities and survival.

2 years

Treatment Details

Interventions

• WT1-specific Donor-derived T Cells

Trial Overview The study tests the safety of different doses of WT1-specific donor-derived T cells after a T-cell depleted allogeneic hematopoietic stem cell transplantation. These lab-grown white cells target the Wilms' tumor protein (WT1) expressed by myeloma cells to see if they can effectively kill them.

Participant Groups

Group I: Pts with Mutiple myeloma Experimental Treatment 5 Interventions

Patients will undergo a preparative regimen with busulfan, melphalan, fludarabine, and anti-thymocyte globulin (ATG), and a T cell depleted stem cell transplant from a histocompatible related or unrelated donor. Hematopoietic stem cell donors for this trial will include individuals who are 10/10 HLA matched or one antigen or allele mismatched at the HLA-A, B, C, DRB1 or DQB1 locus, as defined by high resolution methods .Donors who are 8/10 HLA matched with an antigen or allele mismatched at HLA-DQB1 and at one other locus will also be eligible for the trial. The administration of WT1-specific cytotoxic T cells (WT1 CTLs) post transplantation is integrated to induce complete remissions in patients with residual disease and to decrease the rate of relapse following the allogeneic transplant.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+