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Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA2)
EU CTIS ID: 2022-501927-25-00
What this study is testing
Phase 2 Primary Objectives: Efficacy To assess the clinical efficacy of ALLO-501A as measured by ORR and assessed by IRC in subjects with R/R LBCL.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening.
- Adequate hematological function.
You likely can't join 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.
See the full eligibility criteria
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Absence of significant donor (product)-specific anti-HLA antibodies (DSA) at screening.
- Adequate hematological function.
- Adequate Renal Function.
- Adequate Liver Function.
- 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.
- Autologous HSCT within last 6 months (24 weeks) or allogeneic HSCT within last 6 months (24 weeks) prior to ALLO-647.
- Subjects with active systemic bacterial, fungal, or viral infection requiring systemic treatment (including positive blood cultures within 7 days before starting lymphodepletion).
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United States
- Canada
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United States; Canada; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.