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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-501A, ALLO-647 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-501A | Genetic | ALLO-501A is an allogeneic CAR T cell therapy targeting CD19 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A | Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion | 28 days |
| Phase 1a: Proportion of subjects experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A | DLT is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion | 33 days |
| Phase 1b: Frequency and severity of ALLO-501A treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest | Up to 60 months | |
| Phase 2: Overall Response Rate (ORR) assessed per Independent Review Committee (IRC) | ORR defined as assessment of CR and PR using Lugano classification criteria 2014 | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a, 1b, and 2: Duration of Response (DOR) assessed per IRC (Phase 2 only) and per investigator | DOR is defined only for subjects who experience an objective response and is the time from the first objective response to disease progression or death, whichever comes first per (Cheson et al, 2014) | Up to 60 months |
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Inclusion Criteria:
For subjects with LBCL:
For subjects with CLL/SLL:
For all subjects:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | United States | ||
| Mayo Clinic Hospital |
| 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 |
|
| Phase 1a, 1b, and 2: Overall Response Rate (ORR) assessed per investigator |
| Up to 60 months |
| Phase 1a, 1b, and 2: Best overall response (CR, PR, SD, PD) assessed per IRC (Phase 2 only) and per investigator | CR Complete Response, PR Partial Response, SD Stable Disease, PD Progressive Disease | Up to 60 months |
| Phase 1a, 1b, and 2: Progression Free Survival (PFS) assessed per IRC (Phase 2 only) and per investigator | PFS, defined as time from the enrollment date to progression, relapse, or death | Up to 60 months |
| Phase 1a, 1b, and 2: Time to Response (TTR) assessed per IRC (Phase 2 only) and per investigator | TTR, defined as the time from the enrollment date to the first observed response | Up to 60 months |
| Phase 1a, 1b, and 2: Overall Survival (OS) | OS, defined as the time from the enrollment date to death | Up to 60 months |
| Phase 1a, 1b, and 2: Depth of lymphodepletion as assessed by lymphocyte count | Up to 9 months |
| Phase 1a, 1b, and 2: Duration of lymphodepletion as assessed by lymphocyte recovery | Up to 9 months |
| Phase 1a, 1b, and 2: Serum concentration of ALLO-647 as measured by microgram per microliter for use in a population PK model | Up to 9 months |
| Phase 1a, 1b, and 2: ALLO-501A expansion assessed by peak blood concentration (Cmax) | Up to 9 months |
| Phase 1a, 1b, and 2: ALLO-501A expansion assessed by area under the curve (AUC) | Up to 9 months |
| Phase 1a, 1b, and 2: ALLO-501A persistence assessed by peak blood concentration (Cmax) | Up to 9 months |
| Phase 1a, 1b, and 2: ALLO-501A persistence assessed by area under the curve (AUC) | Up to 9 months |
| Phase 1a, 1b, and 2: Pharmacodynamics will be evaluated on host T cell counts | Up to 9 months |
| Phase 1a, 1b, and 2: The incidence of anti-drug antibodies against ALLO-501A scFv and/or TALEN® | Up to 9 months |
| Phase 1a, 1b, and 2: The incidence of anti-drug antibodies against ALLO-647 | Up to 9 months |
| Phase 1a, 1b, and 2: Adverse Events (AEs) as characterized by preferred term, frequency, severity timing, seriousness, and relationship to ALLO-501A | The incidence and severity of Cytokine Release Syndrome (CRS), Graft-Versus-Host Disease (GVHD), infections, cytopenias, and neurotoxicity | Up to 60 months |
| Phase 1a, 1b, and 2: AEs as characterized by preferred term, frequency, severity, timing, seriousness, and relationship to ALLO-647 | The incidence of infusion-related reactions, cytopenias, and infections | Up to 60 months |
| Phase 1a, 1b, and 2: The incidence and severity of clinically significant laboratory toxicities and relationship to ALLO-647 | Up to 60 months |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| City of Hope | Duarte | California | 91010 | United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Stanford Cancer Institute | Palo Alto | California | 94035 | United States |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218-1234 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06510 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Advent Health | Orlando | Florida | 06510 | United States |
| Moffitt Cancer Center | Tampa | Florida | 33612-9416 | United States |
| Northside Hospital - Atlanta | Atlanta | Georgia | 30342 | United States |
| Augusta University | Augusta | Georgia | 30912 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Avera Medical | Sioux Falls | South Dakota | 57117 | United States |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| St. David's South Austin Medical Center | Austin | Texas | 78704 | United States |
| Texas Oncology | Dallas | Texas | 75251 | United States |
| MD Anderson Cancer Center - University of Texas | Houston | Texas | 77030 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Monash Medical Centre | Clayton | Victoria | 3168 | Australia |
| St. Vincent's Hospital Melbourne | Fitzroy | Victoria | 3065 | Australia |
| QEII Health Sciences Centre-VG Site | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| CHU de Québec -Université Laval; Hôpital de l'Enfant-Jésus | Québec | Quebec | G1J 1Z4 | Canada |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008223 | Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
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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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