Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
The purpose of the ALPHA2 study is to assess the safety, efficacy and cell kinetics of ALLO-501A (an Anti-CD19 Allogenic Car T Cell Therapy) 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 leukaemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALL-647 (an Anti-CD52 Monoclonal Antibody).
Conditions
This trial is treating people with large-B cell lymphoma, chronic lymphocytic leukaemia, or small lymphocytic lymphoma
Eligibility
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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Allogene Therapeutics
Scientific Title
A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
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