Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03651128 | Efficacy and Safety Study of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) | PHASE3 | ACTIVE NOT_RECRUITING | 381 | — | — | Apr 16, 2019 | Apr 8, 2027 | Dec 15, 2022 | 60 | United States, Belgium +11 |
| NCT03601078 | An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma | PHASE2 | COMPLETED | 312 | — | — | Dec 13, 2018 | Jan 15, 2026 | Mar 4, 2026 | 25 | United States, France +4 |
| NCT03361748 | Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma | PHASE2 | COMPLETED | 149 | — | — | Dec 13, 2017 | Dec 20, 2023 | May 23, 2025 | 48 | United States, Belgium +6 |
| NCT04196491 | A Study to Evaluate the Safety of bb2121 in Subjects With High Risk, Newly Diagnosed Multiple Myeloma (NDMM) | PHASE1 | COMPLETED | 13 | — | — | May 27, 2020 | Jun 7, 2023 | Aug 23, 2023 | 22 | United States |
| NCT02658929 | Study of bb2121 in Multiple Myeloma | PHASE1 | COMPLETED | 67 | — | — | Dec 22, 2015 | Sep 22, 2022 | Jan 23, 2023 | 9 | United States |
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...