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| ID | Type | Description | Link |
|---|---|---|---|
| IGNITE Study | Other Identifier | Allogene |
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Terminated (Halted Prematurely)
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The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-605, ALLO-647 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-605 | Genetic | ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-605 that will determine MTD/MAD and select the recommended Phase 2 dose (RP2D) of ALLO-605. | Dose limiting toxicity is defined as protocol-defined ALLO-605 related adverse events with onset within 28 days following infusion | 28 days |
| Phase 1: Proportion of patients experiencing Dose Limiting Toxicities with ALLO-647 [administered in combination with fludarabine/cyclophosphamide administered prior to ALLO-605] | Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 30 days following 1st infusion | 30 days |
| Phase 2: To assess clinical efficacy of ALLO-605 as measured by overall response rate (ORR) | 12 months of study follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon/Colorado Blood Cancer Institute | Denver | Colorado | 80218 | United States | ||
| St. David's South Austin Medical Center |
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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 |
|
| Austin |
| Texas |
| 78704 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Texas Transplant Institute | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| 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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