Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)

Purpose

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Condition

  • Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

For subjects with LBCL: - Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse per WHO 2017 - At least 1 measurable lesion at time of enrollment - Relapsed or refractory disease after at least 2 lines of chemotherapy - Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening (Note: Only applicable for Phase 2) For subjects with CLL/SLL: - Diagnosis of CLL/SLL - Relapsed/refractory disease - Subjects relapsed/refractory to BTKi therapy and high-risk disease - Subjects relapsed/refractory with 2 or more lines of therapy including BTKi and BCL-2 inhibitor (venetoclax) - At least 1 measurable lesion at time of enrollment For all subjects: - Male or female subjects ≥18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 - Adequate hematological, renal, and liver function

Exclusion Criteria

  • Active central nervous system (CNS) involvement by malignancy - Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy - Any other active malignancies that required systemic treatment within 3 years prior to enrollment - Radiation therapy within 2 weeks prior to ALLO-647 - Prior irradiation to >25% of the bone marrow - Hypocellular bone marrow for age by institutional standard as determined from a bone marrow biopsy performed at time of screening (Note: Only applicable for Phase 2). - Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks) - Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ALLO-501A, ALLO-647
  • Genetic: ALLO-501A
    ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
  • Biological: ALLO-647
    ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
  • Drug: Fludarabine
    Chemotherapy for lymphodepletion
  • Drug: Cyclophosphamide
    Chemotherapy for lymphodepletion

Recruiting Locations

Vanderbilt Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Olalekan Oluwole, MD
615-936-8422
olalekan.oluwole@vumc.org

More Details

Status
Recruiting
Sponsor
Allogene Therapeutics

Study Contact

Allogene Therapeutics Inc.
415-604-5696
clinicaltrials@allogene.com