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

Brief 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.
Brief Title
Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
Completion Date
Completion Date Type
Estimated
Conditions
Relapsed/Refractory Large B Cell Lymphoma
Relapsed/Refractory Follicular Lymphoma
Eligibility Criteria
Inclusion Criteria:

* Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
* Relapse or refractory disease after at least 2 lines of chemotherapy
* At least 1 measurable lesion at time of screening.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate hematological, renal, liver, pulmonary, and cardiac functions.

Exclusion Criteria:

* Current or history of central nervous system (CNS) lymphoma.
* Clinically significant CNS dysfunction.
* ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
* Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
* Systemic anticancer therapy within 2 weeks prior to study entry.
* On-going treatment with immunosuppressive agents.
* Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
* Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
* Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.
* Patients unwilling to participate in an extended safety monitoring period
Inclusion Criteria
Inclusion Criteria:

* Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
* Relapse or refractory disease after at least 2 lines of chemotherapy
* At least 1 measurable lesion at time of screening.
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate hematological, renal, liver, pulmonary, and cardiac functions.

Gender
All
Gender Based
false
Keywords
CAR T
Cell Therapy
Allogeneic Cell Therapy
Cellular Immuno-therapy
AlloCAR T
ALLO-501
ALLO-647
LBCL
Lymphoma
Follicular Lymphoma
Large B-Cell Lymphoma
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03939026
Org Class
Industry
Org Full Name
Allogene Therapeutics
Org Study Id
ALLO-501-201
Overall Status
Active, not recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Single-Arm, Open-Label, Phase 1 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-CD19 Allogeneic CAR T Cell Therapy, And ALLO-647, An Anti-CD52 Monoclonal Antibody, in Patients With Relapsed/Refractory Large B-Cell Lymphoma or Follicular Lymphoma
Primary Outcomes
Outcome Description
Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
Outcome Measure
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
Outcome Time Frame
28 days
Outcome Description
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
Outcome Measure
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
Outcome Time Frame
33 days
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ira Braunschweig
Investigator Email
ibraunsc@montefiore.org
Investigator Phone
718-920-4057
Categories Mesh Debug
Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- LYMPHOPROLIFERATIVE DISORDERS
Blood & Bone Marrow Cancers --- LYMPHATIC DISEASES
Blood & Bone Marrow Cancers --- IMMUNOPROLIFERATIVE DISORDERS
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
MeSH Terms
RECURRENCE
LYMPHOMA, FOLLICULAR
LYMPHOMA
DISEASE ATTRIBUTES
PATHOLOGIC PROCESSES
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
LYMPHOMA, NON-HODGKIN
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
LYMPHOPROLIFERATIVE DISORDERS
LYMPHATIC DISEASES
HEMIC AND LYMPHATIC DISEASES
IMMUNOPROLIFERATIVE DISORDERS
IMMUNE SYSTEM DISEASES
FLUDARABINE
CYCLOPHOSPHAMIDE
PHOSPHORAMIDE MUSTARDS
NITROGEN MUSTARD COMPOUNDS
MUSTARD COMPOUNDS
HYDROCARBONS, HALOGENATED
HYDROCARBONS
ORGANIC CHEMICALS
PHOSPHORAMIDES
ORGANOPHOSPHORUS COMPOUNDS