Clinical trial · Interventional

Study of Matched Unrelated Donor T Cell Infusion for Hematologic Malignancies After Allo-HSCT

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

NCT02786485CI-TRIAL-00047495withdrawnPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a Phase I, multicenter, open-label, non-randomized study of matched unrelated donor BPX-501 T cell infusion in adult subjects with hematological malignancies presenting with recurrent disease minimal residual disease (MRD) post-allogeneic transplant.

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
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphomas	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma	Multiple Myeloma	CURATED_EXACT	0.92
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90
Other High-risk Hematological Malignancies	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Rimiducid	Drug	—	UNRESOLVED
rivogenlecleucel	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Rivogenlecleucel & Rimiducid
description
All subjects will receive 3 courses of rivogenlecleucel (BPX-501 T cells) infusions at 30 day intervals with 2 escalating dose levels (DL). DL1 on Day 0 and DL2 on Days 30 and 60. Escalating doses of rimiducid (AP1903) (0.1 mg/kg and 0.4 mg/kg) will be investigated for the treatment of aGvHD after rivogenlecleucel infusion.
interventionNames
1. Biological: rivogenlecleucel
2. Drug: Rimiducid

Primary outcomes (1)

measure
Adverse events
timeFrame
30 days after last dose of study drug (BPX-501 and/or rimiducid)
description
Number of adverse events after study drug (BPX-501 and/or rimiducid) administration as a measure of safety

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 65 Years

Show eligibility criteria text

Inclusion Criteria:

* Subjects aged ≥ 18 yrs and ≤ 65 yrs;
* Clinical diagnosis of one of the following hematological malignancies:

  * Leukemia
  * Myelodysplastic Syndromes
  * Lymphomas
  * Multiple Myeloma
  * Other high-risk hematological malignancy eligible for stem cell transplantation per institutional standard;
* Recurrent disease that presents ≥100 days after, or minimal residual disease (MRD) that presents ≥ 30 days following a hematopoietic stem cell transplant (HSCT) using a matched unrelated donor located through the National Marrow Donor Program (NMDP);
* Life expectancy \>10 weeks;
* Signed donor and patient/guardian informed consent;
* A 8/8 genotypic identical match as determined by high resolution typing for the following genetic loci: human leukocyte antigen (HLA)-A, HLA-B, HLA-C and HLA-DRB1;
* Performance status: Karnofsky score \> 50%;
* Subjects with adequate organ function as measured by:

  * Bone marrow:

    * \> 25% donor T-cell chimerism post-transplant
    * Absolute neutrophil count (ANC) \>1 x 109/L
  * Cardiac: left ventricular ejection fraction (LVEF) at rest ≥ 45%
  * Pulmonary: forced expiratory volume (FEV) 1, forced vital capacity (FVC), diffusion capacity of lunch for carbon monoxide (DLCO) ≥ 50% predicted (corrected for hemoglobin)
  * Hepatic: direct bilirubin ≤ 3x upper limit of normal (ULN), or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5x ULN
  * Renal: creatinine ≤ 2x of ULN for age.

Exclusion Criteria:

* ≥ Grade II acute GVHD or chronic extensive GVHD due to a previous allograft at the time of screening;
* Active central nervous system (CNS) involvement with malignant cells (≤ 2 months prior to consenting);
* 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 β human chorionic gonadotropin \[HCG\] test) or breast-feeding;
* Fertile men or women unwilling to use effective forms of birth control or abstinence for one year after transplantation;
* Bovine product allergy.

References

Publications (0)

Data not yet available

No reference posted for this study.