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CAR T-cell Therapy

WT1-specific T Cells for Multiple Myeloma

Phase 1

Waitlist Available

Led By Sergio Giralt, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have multiple myeloma that has either relapsed or remains refractory following autologous stem cell transplantation and patients who have plasma cell leukemia at diagnosis

Patients with relapsed multiple myeloma following autologous stem cell transplantation who achieved < partial response following additional chemotherapy or who achieved < PR at 3 months following autologous stem cell transplantation and patients with plasma cell leukemia at diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether sensitized white blood cells can kill cancer cells in patients with multiple myeloma.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation, infection risk due to immunosuppression from chemotherapy drugs like busulfan, melphalan and fludarabine; complications from anti-thymocyte globulin (ATG), and issues arising from the stem cell transplant process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My multiple myeloma or plasma cell leukemia didn't fully respond to initial treatments.

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I am between 21 and 73 years old.

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I am mostly able to care for myself and carry out daily activities.

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I have a donor who matches me completely in specific genetic markers.

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I have a donor ready to undergo procedures for my treatment.

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I don't have a perfect match donor, but I have one with only minor mismatches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

assess the toxicities

maximum tolerated dose (MTD)

Secondary outcome measures

serologic response

survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pts with Mutiple myelomaExperimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

busulfan

1999

Completed Phase 3

~3630

melphalan

1994

Completed Phase 3

~3530