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
- 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
- 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,
will be eligible for entry on this protocol.
The following inclusion criteria are also required:
- Patients should be ≥ 21, < 70 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
- Each patient must be willing to participate as a research subject and must sign an
informed consent form.
- 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.