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)
Running, not enrolling · Phase 1/Phase 2
Conditions studied: Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
In brief
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.
Key facts
- Study ID
- NCT04416984
- Run by
- Allogene Therapeutics
- People needed
- 160
- Starts
- 2020-05-21
- Expected to finish
- 2029-05-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- City of Hope — Duarte, California, United States
- UCLA Medical Center — Los Angeles, California, United States
- Stanford Cancer Institute — Palo Alto, California, United States
- Colorado Blood Cancer Institute — Denver, Colorado, United States
- Yale School of Medicine — New Haven, Connecticut, United States
- University of Miami — Miami, Florida, United States
- Advent Health — Orlando, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Northside Hospital - Atlanta — Atlanta, Georgia, United States
- Augusta University — Augusta, Georgia, United States
- Loyola University Medical Center — Maywood, Illinois, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- Providence Portland Medical Center — Portland, Oregon, United States
- Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
- Avera Medical — Sioux Falls, South Dakota, United States
- Vanderbilt Ingram Cancer Center — Nashville, Tennessee, United States
- St. David's South Austin Medical Center — Austin, Texas, United States
- Texas Oncology — Dallas, Texas, United States
- MD Anderson Cancer Center - University of Texas — Houston, Texas, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Full record on ClinicalTrials.gov
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