Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

  • STATUS
    Recruiting
  • End date
    Oct 24, 2021
  • participants needed
    54
  • sponsor
    Allogene Therapeutics
Updated on 24 January 2021

Summary

The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Details
Condition Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma, Relapsed/Refractory Large B Cell Lymphoma, Relapsed/Refractory Follicular Lymphoma
Treatment cyclophosphamide, Fludarabine, ALLO-501, ALLO-647
Clinical Study IdentifierNCT03939026
SponsorAllogene Therapeutics
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Relapsed/Refractory Large B Cell Lymphoma or Relapsed/Refractory Follicular Lymphoma?
Histologically proven relapsed or refractory aggressive large B-cell lymphoma or follicular lymphoma with at least one measurable lesion
At least 2 prior lines of therapies including an anthracycline and an anti-CD20 monoclonal antibody for large B-cell lymphoma and an anti-CD20 monoclonal antibody for follicular lymphoma
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Absence of donor (product)-specific anti-HLA antibodies
Adequate hematological, renal, liver, pulmonary, and cardiac functions

Exclusion Criteria

Current or history of central nervous system (CNS) lymphoma
Clinically significant CNS dysfunction
Current thyroid disorder (including hyperthyroidism) with the exception of hypothyroidism controlled on stable dose of hormone replacement therapy
Prior treatment with any anti-CD52 monoclonal antibody or any anti-CD19 therapies that include the 4G7 scFv clone
Active acute or chronic graft versus host disease (GVHD)
Patients unwilling to participate in an extended safety monitoring period
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