Allogene Therapeutics Reports FDA Clinical Hold of AlloCAR T Trials Based on a Single Patient Case in ALPHA2 Trial
- Testing in a Patient with Low Blood Counts Showed a Chromosomal Abnormality in ALLO-501A CAR T Cells of Unclear Clinical Significance; Patient Achieved a Partial Response to Therapy
- Investigation Ongoing to Further Characterize the Finding, Including Any Clinical Relevance, Evidence of Clonal Expansion, or Potential Relationship to Gene Editing
- Company Believes Data from the ALPHA Trials Demonstrates a Favorable Clinical Profile of ALLO-501A
- FDA Continues to Review End of Phase 1 Materials for a Phase 2 Pivotal Trial of ALLO-501A
- Company to Host Conference Call Today at 2:00 p.m. PT/
5:00 p.m. ET
The Company expects to provide additional updates in the coming weeks following consultation with the FDA. The FDA continues to actively review the end of Phase 1 materials submitted in anticipation for an ALLO-501A pivotal Phase 2 trial.
“Patient safety is our highest priority, and we are committed to working closely with the FDA to evaluate any potential clinical implications of this finding, and determine next steps for advancing ALLO-501A and our clinical programs,” said
The clinical hold follows the Company’s notification to the FDA of a chromosomal abnormality in an ALPHA2 study patient which was detected in a bone marrow biopsy undertaken to assess pancytopenia (low blood counts). An investigation is underway to further characterize the observed abnormality, including any clinical relevance, evidence of clonal expansion, or potential relationship to gene editing.
The single case involves a patient with Stage IV transformed follicular lymphoma and c-myc rearrangement whose cancer was refractory to two prior lines of immune-chemotherapy and additional radiation therapy. The patient could not receive an autologous CD19 CAR T cell therapy due to manufacturing failure associated with inadequate expansion of autologous CAR T cells.
Following infusion of ALLO-501A, the patient experienced Grade 1 CRS and Grade 2 ICANS, which required a course of high dose steroid therapy. The patient subsequently developed progressive pancytopenia and a bone marrow biopsy showed aplastic anemia and the presence of ALLO-501A CAR T cells with the chromosomal abnormality. Early translational data showed that the CAR T cells expanded, peaking on Day 28, and undergoing contraction thereafter. The patient had a partial response to ALLO-501A and subsequently underwent allogeneic stem cell transplantation. Prolonged cytopenia requiring rescue stem cell transplantation has been reported in autologous CAR T therapies.
Allogene has dosed more than 100 patients with its gene edited AlloCAR T products. The Company believes the data generated from the ALPHA trials support a favorable clinical profile for ALLO-501A in patients with large B cell lymphoma.
Conference Call and Webcast Details
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This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the clinical significance of the chromosomal abnormality and any relationship to gene editing, the clinical profile of ALLO-501A, the timing and result of additional communications with the FDA regarding the clinical hold or the ALLO-501A end of Phase 1 materials, the ability to develop allogeneic CAR T therapies for cancer, and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogene’s expectations and actual results as discussed in greater detail in Allogene’s filings with the
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Source: Allogene Therapeutics, Inc.