Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant

Status:Active, not recruiting
Conditions:Blood Cancer, Lymphoma, Hematology, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Age Range:18 - 65
Start Date:July 2016
End Date:December 2020

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A Phase I Study of Donor BPX-501 T Cell Infusion for Adults With Recurrent or Minimal Residual Disease Hematologic Malignancies Post-Allogeneic Transplant

A Phase I study of BPX-501 T cell infusion in adults with recurrent or minimal residual
disease (MRD) hematologic malignancies post-allogeneic transplant. The treatment consists of
increasing doses of BPX-501 T cell infusions to achieve a clinical response. AP1903 will be
investigated for the treatment of aGvHD after BPX-501 T cell infusion to determine a dose
that can mitigate GvHD and preserve the graft versus leukemia effect.

Unmanipulated donor lymphocyte infusion (DLI) is used after stem cell transplantation to
treat and prevent relapse, to prevent infections and to establish full donor chimerism. The
addition of mature T cells which exhibit a broad repertoire of T cell immunity against viral
and cancer antigens, might provide a clinical benefit. However, an expected side effect of
the presence of mature T cells is the potential occurrence of acute graft-versus-host disease
(aGVHD). BPX-501 contains genetically modified donor T cells that have an inducible safety
switch iCasp9 suicide gene. Evidence has emerged that escalating DLI has achieved higher
clinical response rate with lower GVHD occurrence. Optimization of DLI dose and schedule as
well as strategies of donor T-cell manipulation may lead to the consistent ability to
separate GVHD from GvL (graft-versus-leukemia) activity and improve the safety of DLI

Inclusion Criteria:

1. Subjects aged >18yrs and < 65yrs

2. Clinical diagnosis of one of the following adult hematological malignancies

1. Leukemia

2. Myelodysplastic Syndromes

3. Lymphomas

4. Multiple myeloma

5. Other high-risk hematologic malignancies eligible for stem cell transplantation
per institutional standard Life expectancy >10 weeks

3. Evidence of recurrent disease that presents > 100 days or minimal residual disease
(MRD) that presents > 30 days after one of the following:

1. Matched related HSCT

2. Mismatched related HSCT

4. Signed patient informed consent;

5. A minimum genotypic identical match of 4/8 is required, as determined by high
resolution typing, at least one allele of each of the following genetic loci: HLA-A,
HLA-B, HLA-Cw, and HLA- DRB1

6. Performance status: Karnofsky score > 50%

7. Subjects with adequate organ function as measured by:

1. Bone marrow:

- > 25% donor T-cell chimerism

- ANC >1 x 10E9/L

2. Cardiac: left ventricular ejection fraction at rest must be >45%.

3. Hepatic: direct bilirubin ≤ 3 x upper limit of normal, or AST/ALT ≤ 5 x upper
limit of normal

4. Renal: creatinine ≤ 2x of ULN for age

5. Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for

Exclusion Criteria:

1. ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of

2. Active CNS involvement by malignant cells;

3. Current uncontrolled bacterial, viral or fungal infection (currently taking medication
with evidence of progression of clinical symptoms or radiologic findings). The
principal investigator is the final arbiter of this criterion;

4. Positive HIV serology or viral RNA

5. Pregnancy (positive serum βHCG test) or breast-feeding;

6. Subjects of reproductive potential unwilling to use effective forms of birth control
or abstinence for a year after transplantation;

7. Bovine product allergy
We found this trial at
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
Principal Investigator: Madhuri Vusirikala, M.D.
Phone: 214-648-5130
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
Dallas, TX
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Richard T Maziarz, MD
Phone: 503-418-0128
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
Portland, OR
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1100 Fairview Avenue North
Seattle, Washington 98109
(206) 667-5000
Principal Investigator: Elizabeth Krakow, MD
Phone: 206-667-6993
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
Seattle, WA
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Atlanta, Georgia 30342
Principal Investigator: Scott R Solomon, MD
Phone: 404-255-1930
Atlanta, GA
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Buffalo, New York 14263
Principal Investigator: George Chen, M.D.
Phone: 716-845-1761
Buffalo, NY
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Michael Byrne, MD
Phone: 615-875-6278
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
Nashville, TN
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Westwood, Kansas 66205
Principal Investigator: Joseph McGuirk, MD
Westwood, KS
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