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| Name | Class |
|---|---|
| Arcellx, Inc. | INDUSTRY |
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Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM 1 | Experimental | Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anitocabtagene-autoleucel | Drug | Chimeric Antigen Receptor T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs), including DLT(s) | 24 months | |
| Establish the RP2D of the investigational agent | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response (BOR) by International Myeloma Working Group (IMWG) Consensus Criteria | 24 months | |
| Overall Response Rate (ORR) by IMWG Consensus Criteria | 24 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arcellx, Inc. | Arcellx, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Cellular Therapeutics Facility, DCAM 0800A | Chicago | Illinois | 60637 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35737298 | Derived | Buonato JM, Edwards JP, Zaritskaya L, Witter AR, Gupta A, LaFleur DW, Tice DA, Richman LK, Hilbert DM. Preclinical Efficacy of BCMA-Directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain. Mol Cancer Ther. 2022 Jul 5;21(7):1171-1183. doi: 10.1158/1535-7163.MCT-21-0552. | |
| 35468618 | Derived |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
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| PK Parameter for Anitocabtagene-Autoleucel: Cmax |
Cmax is defined as the maximum observed concentration of drug. |
| Day 1 up to 24 months |
| PK Parameter for Anitocabtagene-autoleucel: Tmax | Tmax is defined as the time (observed time point) of Cmax. | Day 1 up to 24 months |
| PK Parameter for Anitocabtagene-Autoleucel: Area under the curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. | Day 1 up to 24 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Froedtert Hospital/Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Frigault MJ, Bishop MR, Rosenblatt J, O'Donnell EK, Raje N, Cook D, Yee AJ, Logan E, Avigan DE, Jakubowiak A, Shaw K, Daley H, Nikiforow S, Griffin F, Cornwell C, Shen A, Heery C, Maus MV. Phase 1 study of CART-ddBCMA for the treatment of subjects with relapsed and refractory multiple myeloma. Blood Adv. 2023 Mar 14;7(5):768-777. doi: 10.1182/bloodadvances.2022007210. |
| 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 |