Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Allogene Therapeutics
Conditions:
Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04416984
Start Date
May 21 2020
End Date
May 1 2029
Last Update
January 24 2025
Active Locations (23)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
3
City of Hope
Duarte, California, United States, 91010
4
UCLA Medical Center
Los Angeles, California, United States, 90095