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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


Phase 1
21 Years
69 Years
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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,
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
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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

assess the toxicities

Outcome Description:

DLT will be defined as a grade III or greater toxicity developing within 3 weeks of the T cell infusion, as graded by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 or new development of grade II-IV acute GVHD within 3 weeks of the T cell infusion that requires treatment with systemic glucocorticosteroids. Patients will be evaluated for 21 days for grade III or greater toxicities.

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Guenther Koehne, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

12-175

NCT ID:

NCT01758328

Start Date:

December 2012

Completion Date:

December 2014

Related Keywords:

  • Multiple Myeloma
  • BUSULFAN
  • FLUDARABINE
  • G-CSF
  • MELPHALAN
  • RABBIT ATG WT1
  • PEPTIDE SPECIFIC T CELLS
  • 12-175
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021