Dose Escalation Trial of WT1-specific Donor-derived T Cells Following T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma



Status:Active, not recruiting
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:21 - 72
Updated:6/27/2018
Start Date:December 2012
End Date:December 2019

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A Phase I Dose Escalation Trial of WT1-specific Donor-derived T Cells Following T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Relapsed/Refractory Multiple Myeloma

The purpose of this study is to test the safety of specialized white cells from the donor at
different doses. They are called WT1 sensitized T cells. They have been grown in the lab and
are immunized against a protein. The protein is called the Wilms' tumor protein, or WT1. The
multiple myeloma cells make and express this protein". The investigators want to learn
whether the WT1 sensitized T cells will attach to the protein and kill the myeloma cells. The
investigators want to find out what effects, good and/or bad, it has on the patient and
multiple myeloma.


Inclusion Criteria:

Diagnosis:

- 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.

DONOR: Patients must have a healthy HLA matched or mismatched related or unrelated donor
who is willing to receive G-CSF injections and undergo apheresis for PBSC collection, or
undergo a marrow harvesting procedure.

- HLA-matched related and unrelated donors Patients who have an HLA-matched related or
unrelated donor are eligible for entry on this protocol. This will include a healthy
donor who is genotypically matched at all A, B, C, DRB1 and DQB1 loci, as tested by
DNA analysis.

- HLA- mismatched related and unrelated donors

- Patients who do not have an HLA-matched donor but have a related or unrelated donor
who have one antigen or one allele mismatch at the HLA A, B, C, DRB1 or DQB1 loci or
who have two mismatches, at HLA-DQB1 and at one other locus, will be eligible for
entry on this protocol.

The following inclusion criteria are also required:

- Patients should be ≥ 21, < 73 years old.

- Patients may be of either gender or any ethnic background.

- Patients must have a Karnofsky (adult) or Performance Status > 70%

- Patients must have adequate organ function measured by:

1. Cardiac: asymptomatic or if symptomatic then LVEF at rest must be > 50% and must
improve with exercise.

2. Hepatic: < 3x ULN ALT and < 1.5 total serum bilirubin, unless there is congenital
benign hyperbilirubinemia.

3. Renal: serum creatinine <1.2 mg/dl or if serum creatinine is outside the normal
range, then CrCl > 40 ml/min (measured or calculated/estimated) with dose
adjustment of Fludarabine for <70ml/min.

4. Pulmonary: asymptomatic or if symptomatic, DLCO > 50% of predicted (corrected for
hemoglobin)

- Each patient must be willing to participate as a research subject and must sign an
informed consent form.

Exclusion Criteria:

- Female patients who are pregnant or breast-feeding

- Active viral, bacterial or fungal infection

- Patient seropositive for HIV-I/II; HTLV -I/II

- Patients who have had a previous malignancy that is not in remission.

- Patients with known hypersensitivity to mouse proteins (murine antibodies in ISOLEX)
if receiving SBA-E- bone marrow, or chicken egg products.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Guenther Koehne, MD, PhD
Phone: 212-639-8599
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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