Ireland
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Active, not recruiting Phase 1

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

NCT02477878 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2016-07
Last updated
2022-07-12

Condition(s) studied

LeukemiaMyelodysplastic SyndromesLymphomaMultiple MyelomaHematologic Neoplasms

Investigational drug(s) / intervention(s)

BPX-501Rimiducid →

BPX-501: Biological: T cells transduced with CaspaCIDe suicide gene

Rimiducid: Rimiducid administered to treat GVHD

Study summary

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. Rimiducid 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 hemoglobin) Exclusion Criteria: 1. ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at time of screening; 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

Primary outcome measure(s)

  • BPX-501 Safety — 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 — 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 — Month 24
    Assess incidence and severity of acute and chronic GvHD
  • Rimiducid Activity — Month 24
    Determine the effect of Rimiducid on mitigating GvHD
  • Rimiducid Efficacy — Month 24
    Assess time to resolution of GvHD after administration of Rimiducid

Trial sites (5)

FacilityCityRegionStatus
BMT Program at Northside Hospital Atlanta Georgia
University of Kansas Westwood Kansas
Roswell Park Buffalo New York
Oregon Health & Science University Portland Oregon
UT Southwestern Medical Center Dallas Texas
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02477878 on ClinicalTrials.gov ↗ ← All trials in the USA