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The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-647, ALLO-501 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-501 | Genetic | ALLO-501 is an allogeneic CAR T cell therapy targeting CD19 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501 | Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion | 28 days |
| Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501 | Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion | 33 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39946666 | Derived | Locke FL, Munoz JL, Tees MT, Lekakis LJ, de Vos S, Nath R, Stevens DA, Malik SA, Shouse GP, Hamadani M, Oluwole OO, Perales MA, Miklos DB, Fisher PW, Feng A, Navale L, Le Gall JB, Neelapu SS. Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies. J Clin Oncol. 2025 May 10;43(14):1695-1705. doi: 10.1200/JCO-24-01933. Epub 2025 Feb 13. |
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| ALLO-647 |
| Biological |
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen |
|
| Fludarabine | Drug | Chemotherapy for lymphodepletion |
|
| Cyclophosphamide | Drug | Chemotherapy for lymphodepletion |
|
| Stanford |
| California |
| 94305 |
| United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| St. Davids South Austin Medical Center | Austin | Texas | 78704 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D008224 | Lymphoma, Follicular |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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