Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
bb2121 · 5 trials · 1 indication
Time from randomization to the first documentation of progressive disease based on the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma assessed by an independent response committee (IRC) or death due to any cause, whichever occurs first.
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Percentage of subjects who achieved CR or stringent CR according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigator
Number of participants who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by an independent response committee (IRC).
DLTs will be assessed during the DLT interval (ie, within 21 days immediately after bb2121 infusion). DLTs are defined as any bb2121 related Grade 3 to 5 toxicity.
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
| Arm | Type | Description |
|---|---|---|
| Arm A - Administration of bb2121 | EXPERIMENTAL | bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy |
| Arm B- standard regimens as per Investigator's discretion | EXPERIMENTAL | The participants will receive one of following regimens dependent on the subject's most recent anti-myeloma treatment regimen: * Daratumumab (DARA) in combination with pomalidomide (POM) and low-dose dexamethasone (dex) (DPd) OR * DARA in combination with bortezomib (BTZ) and low-dose dex (DVd) OR * Ixazomib (IXA) in combination with lenalidomide (LEN) and low-dose dex (IRd) OR * Carfilzomib (CFZ) in combination with low-dose dexamethasone (Kd) OR * Elotuzumab (ELO) in combination with POM and low-dose dexamethasone (EPd) |
| Cohort 1: BB2121 in relapsed and refractory multiple myeloma participants | EXPERIMENTAL | bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy |
| Cohort 1b: BB2121 with talquetamab in relapsed and refractory multiple myeloma participants | EXPERIMENTAL | - |
| Cohort 2a: BB2121 in multiple myeloma with Autologous stem cell transplantation participants | EXPERIMENTAL | - |
| Cohort 2b: BB2121 in multiple myeloma without Autologous stem cell transplantation participants | EXPERIMENTAL | - |
| Cohort 2c: BB2121 in multiple myeloma participants with inadequate response post ASCT | EXPERIMENTAL | - |
| Cohort 3: BB2121 with lenalidomide maintenance in newly diagnosed multiple myeloma | EXPERIMENTAL | - |
| Administration of bb2121 | EXPERIMENTAL | bb2121 autologous CAR T cells will be infused at a dose ranging from 15 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy. |
| Dose Escalation | EXPERIMENTAL | * bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 800 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy with a planned starting dose of 450 x 10\^6 CAR+ T cells. * Lenalidomide maintenance therapy is recommended for all patients and should be initiated upon adequate bone marrow recovery or from 90-day post-bb2121 infusion, whichever is later |
| bb2121 | EXPERIMENTAL | bb2121 autologous CAR T cells will be infused at a dose ranging from 150 - 450 x 10\^6 CAR+ T cells after receiving lymphodepleting chemotherapy |
| Name | Type | Description |
|---|---|---|
| bb2121 | BIOLOGICAL | bb2121 |
| Daratumumab | DRUG | Daratumumab |
| Pomalidomide | DRUG | Pomalidomide |
| Dexamethasone | DRUG | Dexamethasone |
| Bortezomib | DRUG | Bortezomib |
| Ixazomib | DRUG | Ixazomib |
| Lenalidomide | DRUG | Lenalidomide |
| Carfilzomib | DRUG | Carfilzomib |
| Elotuzumab | DRUG | Elotuzumab |
| Lenalomide | DRUG | Specified dose on specified days |
| Talquetamab | DRUG | Specified dose on specified days |
| Fludarabine | DRUG | Lymphodepleting Chemotherapy |
| Cyclophosphamide | DRUG | Lymphodepleting Chemotherapy |
Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF). 2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being condu...
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bb2121 is an investigational monoclonal antibody being developed for the treatment of multiple myeloma, a cancer of plasma cells. It has been studied in patients with relapsed and refractory multiple myeloma, as well as in those with high-risk or newly diagnosed multiple myeloma. The drug is currently in Phase 3 clinical development.
bb2121 is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the stock exchange. The company has conducted multiple clinical trials of bb2121 across various phases and countries, including the United States, Belgium, Canada, France, Germany, Italy, Japan, Spain, and the United Kingdom.
bb2121 is currently in Phase 3 clinical development for multiple myeloma. It has completed earlier phase trials, including Phase 1 and Phase 2 studies. As of now, bb2121 is not FDA approved and remains an investigational drug under clinical investigation for the treatment of multiple myeloma.
bb2121 has been studied in several clinical trials, including NCT02658929, a Phase 1 study in multiple myeloma; NCT03361748, a Phase 2 study in relapsed and refractory multiple myeloma; NCT03601078, a Phase 2 study in relapsed and refractory and high-risk multiple myeloma; and NCT04196491, a Phase 1 study in high-risk newly diagnosed multiple myeloma. All trials have been completed.
bb2121 is also known as idecabtagene vicleucel, a CAR T-cell therapy. It is being developed by Bristol-Myers Squibb for multiple myeloma. The drug has been evaluated in clinical trials for relapsed and refractory multiple myeloma and is currently in Phase 3 development.