Clinical trial · Interventional
Study of Gene Modified Donor T Cell Infusion in Patients With Recurrent Disease After Allogeneic Transplant
A Phase I Study of Donor BPX-501 T Cell Infusion for Adults With Recurrent or Minimal Residual Disease Hematologic Malignancies Post-Allogeneic Transplant
NCT02477878CI-TRIAL-00059594active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BPX-501 | Biological | — | UNRESOLVED |
| Rimiducid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BPX-501 and Rimiducid
- description
- 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.
- interventionNames
- Biological: BPX-501
- Drug: Rimiducid
Primary outcomes (5)
- measure
- BPX-501 Safety
- timeFrame
- Month 24
- description
- 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
- measure
- Rimiducid Safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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 allergyReferences
Publications (0)
Data not yet available
No reference posted for this study.