Clinical trial NCT03939026: Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Relapsed/Refractory Large B Cell Lymphoma
Relapsed/Refractory Follicular Lymphoma
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
Lead sponsor: Allogene Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-05-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
timeFrame: 28 days
measure: Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
timeFrame: 33 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: Stanford
country: United States
facility: Stanford University
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Louisville
country: United States
facility: Norton Cancer Institute
state: Kentucky
city: Austin
country: United States
facility: St. Davids South Austin Medical Center
state: Texas
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
References: