Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant
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ClinicalTrials.gov Identifier: NCT02477878 |
Recruitment Status :
Active, not recruiting
First Posted : June 23, 2015
Last Update Posted : October 5, 2020
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Condition or disease | Intervention/treatment | Phase |
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Leukemia Myelodysplastic Syndromes Lymphoma Multiple Myeloma Hematologic Neoplasms | Biological: BPX-501 Drug: Rimiducid | Phase 1 |
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study of Donor BPX-501 T Cell Infusion for Adults With Recurrent or Minimal Residual Disease Hematologic Malignancies Post-Allogeneic Transplant |
Actual Study Start Date : | July 2016 |
Actual Primary Completion Date : | January 2020 |
Estimated Study Completion Date : | January 2033 |

Arm | Intervention/treatment |
---|---|
Experimental: BPX-501 and Rimiducid
All subjects will receive 3 cycles of BPX-501 T cell infusions at escalating dose levels (DL). DL1 on Day 0, DL2 on Days 30 and 60. The first dose of BPX-501 T cells will occur ≥30 days after hematopoietic stem cell transplant (HSCT). Two doses of Rimiducid ( 0.1 mg/kg and 0.4 mg/kg) will be investigated for the treatment of aGvHD after BPX-501 T cell infusion. |
Biological: BPX-501
Biological: T cells transduced with CaspaCIDe suicide gene Drug: Rimiducid Rimiducid administered to treat GVHD
Other Name: AP1903 |
- BPX-501 Safety [ Time Frame: Month 24 ]To evaluate the safety of 2 stratified dose levels of BPX-501 T cell infusions based on patient-donor match in adult subjects with hematological malignancies
- Rimiducid Safety [ Time Frame: Month 24 ]evaluate the safety of the infusion of escalating doses of dimerizer drug rimiducid (AP1903) in subjects who develop acute GvHD after BPX-501 infusion
- GvHD [ Time Frame: Month 24 ]Assess incidence and severity of acute and chronic GvHD
- Rimiducid Activity [ Time Frame: Month 24 ]Determine the effect of Rimiducid on mitigating GvHD
- Rimiducid Efficacy [ Time Frame: Month 24 ]Assess time to resolution of GvHD after administration of Rimiducid
- Response Rate [ Time Frame: Month 24 ]Measure overall survival, disease free survival and response rates after BPX-501 infusion
- Translational [ Time Frame: Month 24 ]Evaluate BPX-501 T cell function

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects aged >18yrs and < 65yrs
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Clinical diagnosis of one of the following adult hematological malignancies
- Leukemia
- Myelodysplastic Syndromes
- Lymphomas
- Multiple myeloma
- Other high-risk hematologic malignancies eligible for stem cell transplantation per institutional standard Life expectancy >10 weeks
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Evidence of recurrent disease that presents > 100 days or minimal residual disease (MRD) that presents > 30 days after one of the following:
- Matched related HSCT
- Mismatched related HSCT
- Signed patient informed consent;
- 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
- Performance status: Karnofsky score > 50%
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Subjects with adequate organ function as measured by:
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Bone marrow:
- > 25% donor T-cell chimerism
- ANC >1 x 10E9/L
- Cardiac: left ventricular ejection fraction at rest must be >45%.
- Hepatic: direct bilirubin ≤ 3 x upper limit of normal, or AST/ALT ≤ 5 x upper limit of normal
- Renal: creatinine ≤ 2x of ULN for age
- Pulmonary: FEV 1, FVC, DLCO (diffusion capacity) > 50% predicted (corrected for hemoglobin)
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Exclusion Criteria:
- ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of screening;
- Active CNS involvement by malignant cells;
- 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;
- Positive HIV serology or viral RNA
- Pregnancy (positive serum βHCG test) or breast-feeding;
- Subjects of reproductive potential unwilling to use effective forms of birth control or abstinence for a year after transplantation;
- Bovine product allergy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477878
United States, Georgia | |
BMT Program at Northside Hospital | |
Atlanta, Georgia, United States, 30342 | |
United States, Kansas | |
University of Kansas | |
Westwood, Kansas, United States, 66205 | |
United States, New York | |
Roswell Park | |
Buffalo, New York, United States, 14263 | |
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 | |
United States, Texas | |
UT Southwestern Medical Center | |
Dallas, Texas, United States, 75390 |
Study Director: | Bellicum Pharmaceuticals | Bellicum Pharmaceuticals, Inc. |
Responsible Party: | Bellicum Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02477878 |
Other Study ID Numbers: |
BP-008 |
First Posted: | June 23, 2015 Key Record Dates |
Last Update Posted: | October 5, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Adult leukemias and myelodysplasia Adult lymphomas Adult multiple myeloma allogeneic stem cell transplant donor lymphocyte infusion |
Multiple Myeloma Hematologic Neoplasms Myelodysplastic Syndromes Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell |
Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Neoplasms by Site |