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Trial Title:
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
NCT ID:
NCT01758328
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Fludarabine
Melphalan
Busulfan
Antilymphocyte Serum
Conditions: Keywords:
BUSULFAN
FLUDARABINE
G-CSF
MELPHALAN
RABBIT ATG WT1
PEPTIDE SPECIFIC T CELLS
12-175
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
busulfan
Arm group label:
Pts with Mutiple myeloma
Intervention type:
Drug
Intervention name:
melphalan
Arm group label:
Pts with Mutiple myeloma
Intervention type:
Drug
Intervention name:
fludarabine
Arm group label:
Pts with Mutiple myeloma
Intervention type:
Biological
Intervention name:
anti-thymocyte globulin (ATG)
Arm group label:
Pts with Mutiple myeloma
Intervention type:
Procedure
Intervention name:
a T cell depleted stem cell transplant
Arm group label:
Pts with Mutiple myeloma
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
21 Years
Maximum age:
72 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Start date:
December 2012
Completion date:
December 2024
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01758328
http://www.mskcc.org/
