Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Teclistamab (IV)
Teclistamab · 14 trials · 10 indications
The proportion of participants achieving measurable residual disease negativity at a sensitivity level of 10\^-5 together with complete response, assessed according to International Myeloma Working Group (IMWG) criteria at the specified timepoint.
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.
Severity for CRS will be graded as follows: Grade 1: Fever (Temperature greater than or equal to \[\>=\] 38°C); Grade 2: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring low-flow nasal cannula or blow-by; Grade 3: Fever (Temperature \>=38°C) with either: hypotension and/or hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask; Grade 4: Fever (Temperature \>=38°C) with either: hypotension requiring multiple vasopressors (excluding vasopressin), and/or hypoxia requiring positive pressure and Grade 5: Death.
PFS is defined as the duration from the date of randomization to either progressive disease or death, whichever comes first. Disease progression will be determined according to the International Myeloma Working Group (IMWG) response criteria.
12-month MRD-negative CR is defined as participants who achieve MRD-negative status at 12 months, as determined by next-generation sequencing (NGS) with sensitivity of 10\^-5, prior to progressive disease or subsequent anti-myeloma therapy and who also achieve CR or better, according to IMWG criteria.
to determine the Complete Response Rate (CRR), defined as the proportion of subjects achieving complete response (CR) or stringent complete response (sCR) according to IMWG criteria at the 'Pre-Maintenance' timepoint (after completion of Immunotherapy #4, Cycle 4)
determine the 2-year Progression-Free Survival (PFS) percentage in subjects with high-risk multiple myeloma (HRMM) treated with the sequential use of bispecific antibodies.
Overall immunoglobulin M (IgM) efficacy will be evaluated by assessing the IgM response rate and the objective response rate (ORR, PR or better; at least 25% improvement in IgM from baseline). Overall response rate (ORR) includes patients who achieved minor response (MR), partial response (PR), very good partial response (VGPR), and complete response (CR). Response rates will be presented with exact 95% confidence intervals. With 24 patients, there is 99% power to reject a null rate of IgM response of 0.30 assuming an alternative IgM response rate of 0.70 based on the exact binomial exact test with a one-sided significance level of 0.03. The alternative IgM response rate will be rejected if at least 12 of 24 patients have a response.
Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response.
Percentage of participants achieving CR or better according to EHA/ISA guidelines
Evaluate the overall incidence of CRS in the first 2 cycles after a single dose of prophylactic tocilizumab given 2 to 4 hours prior to step-up dose 1 of teclistamab or talquetamab or after 3 doses of oral dexamethasone given after each step-up dose and the first full dose of teclistamab.
The complete response rate (CRR) was defined as the proportion of participants achieving complete response (CR) based on International Myeloma Working Group (IMWG) Response criteria. CR defined as requires all of the following: * Disappearance of the original monoclonal protein from the blood and urine on at least two determinations for a minimum of six weeks by immunofixation studies. * \<5% plasma cells in the bone marrow on at least two determinations for a minimum of six weeks. * No increase in the size or number of lytic bone lesions (development of a compression fracture does not exclude response). * Disappearance of soft tissue plasmacytomas for at least six weeks.
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
Cmax is defined as the maximum observed serum concentration of teclistamab (after first treatment dose).
AUCtau is defined as area under the concentration-time curve during dosing interval of teclistamab (after first treatment dose).
Ctrough is defined as observed serum concentration immediately prior to the next study treatment administration.
An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.
Number of participants with AEs by severity will be reported.
Number of participants with abnormalities in laboratory values (such as serum chemistry, hematology) will be reported.
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.
A SAE is any untoward medical occurrence that at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is a suspected transmission of any infectious agent via a medicinal product; is medically important.
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the 2016 International Myeloma Working Group (IMWG) response criteria.
The Dose Limiting Toxicities (DLTs) are based on drug related adverse events and defined as any of the following events: hematological / non hematological toxicity of Grade 3 or higher.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
| Arm | Type | Description |
|---|---|---|
| Arm A (Tec-Tal) | EXPERIMENTAL | Participants receive maintenance therapy with teclistamab in combination with talquetamab. The study evaluates whether maintenance treatment with dual immunotherapy can improve eradication of measurable residual disease in participants with newly diagnosed multiple myeloma who remain MRD-positive after autologous stem cell transplantation. Treatment is administered according to protocol-defined procedures, and participants are followed for assessment of efficacy and safety outcomes. |
| Arm B (Dara-R) | ACTIVE_COMPARATOR | Participants receive maintenance therapy with daratumumab and lenalidomide. This treatment regimen represents the comparator maintenance strategy for participants with newly diagnosed multiple myeloma who remain MRD-positive after autologous stem cell transplantation. Treatment is administered according to protocol-defined procedures, and participants are followed for assessment of efficacy and safety outcomes. |
| Teclistamab | EXPERIMENTAL | Participants will receive teclistamab monotherapy in Part 1 and an alternative dosing regimen of teclistamab in Part 2. |
| Pomalidomide, Bortezomib and Dexamethasone (PVd) or Carfilzomib and Dexamethasone (Kd) | EXPERIMENTAL | Participants will receive either PVd or Kd based on principal investigator's choice during Part 1 of the study. |
| Teclistamab, Daratumumab SC, and Lenalidomide (Tec-DR) | EXPERIMENTAL | Participants will receive teclistamab as subcutaneous (SC) injection in combination with daratumumab and lenalidomide. |
| Talquetamab, Daratumumab SC, and Lenalidomide (Tal-DR) | EXPERIMENTAL | Participants will receive talquetamab as SC injection in combination with daratumumab and lenalidomide. |
| Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) | ACTIVE_COMPARATOR | Participants will receive daratumumab as SC injection with lenalidomide and dexamethasone. |
| MRD-negative | EXPERIMENTAL | Subjects who are MRD-negative (a threshold of 10\^5) will be given teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression. |
| MRD-positive | EXPERIMENTAL | Subjects who are MRD-positive (a threshold of 10\^5) will receive a single melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by a 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression. MRD status with classification threshold of 10\^5 will be assessed by standardized flow cytometry. |
| Teclistamab-Daratumumab | EXPERIMENTAL | All participants in this study will receive teclistamab and daratumumab. |
| Teclistamab/Tocilizumab | EXPERIMENTAL | Participants will receive step up dosing of Teclistamab following the recommended dosage of TECVAYLI™ USPI followed by weekly dosing for twelve 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 2 weeks for participants who achieve partial response (PR) or better after 6 months of therapy. |
| Talquetamab/Tocilizumab | EXPERIMENTAL | Participants will receive step up dosing of Talquetamab following the recommended dosage of TALVEY™ USPI followed by every 2 week dosing for six 28-day cycles, until disease progression, unacceptable toxicity, or the EOT (end of Cycle 6). Talquetamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better after Cycle 4. Participants in the talquetemab arm cannot be re-screened for or re-enrolled into the teclistamab arm. |
| Teclistamab/Oral Dexamethasone | EXPERIMENTAL | Participants will receive step-up dosing of Teclistamab followed by weekly dosing for two cycles, every other week during Cycles 3-6 and once every 4 weeks from Cycles 7 through 12 until disease progression, unacceptable toxicity, or the EOT (end of Cycle 12). Teclistamab dosing may be reduced to once every 4 weeks for participants who achieve very good partial response (VGPR) or better starting with Cycle 3. |
| Lenalidomide + Dexamethasone (LD) | ACTIVE_COMPARATOR | Each study treatment cycle lasts 28 days. Participants will be randomized into either Teclistamab arm or Lenalidomine + Dexamethoasone arm * Lenalidomine * Dexamethoasone |
| Part 3: Teclistamab | EXPERIMENTAL | Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C. |
| Arm A: Pre-change Teclistamab | EXPERIMENTAL | Participants will receive teclistamab monotherapy (made from the pre-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to Drug Access Long-term Extension (DA-LTE) phase and will continue to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary. |
| Arm B: Post-change Teclistamab | EXPERIMENTAL | Participants will receive teclistamab monotherapy (made from the post-change manufacturing process) for all step-up and treatment doses until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent to treatment, or end of the study, whichever occurs first. Following completion of the planned analysis per protocol, approval of Amendment 3, and upon sponsor notification, participants from treatment phase will be transitioned to DA-LTE phase to receive the study treatment until they have either discontinued, withdrawn, or transitioned to one of the criteria specified in the protocol. Based on primary analysis demonstrating comparability between pre- and post-change teclistamab, flexibility has been introduced to allow participants to switch from their current teclistamab treatment, if necessary. |
| Treatment Regimen A: Teclistamab + Daratumumab + Pomalidomide | EXPERIMENTAL | Participants will receive teclistamab plus daratumumab plus pomalidomide. |
| Treatment Regimen B: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (21-day Cycles) | EXPERIMENTAL | Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 21-day cycles. |
| Treatment Regimen C: Teclistamab + Nirogacestat | EXPERIMENTAL | Participants will receive teclistamab plus nirogacestat. |
| Treatment Regimen D: Teclistamab + Lenalidomide | EXPERIMENTAL | Participants will receive teclistamab plus lenalidomide. |
| Treatment Regimen E: Teclistamab + Daratumumab + Lenalidomide | EXPERIMENTAL | Participants will receive teclistamab plus daratumumab plus lenalidomide. |
| Treatment Regimen F: Teclistamab + Daratumumab + Lenalidomide + Bortezomib (28-day Cycles) | EXPERIMENTAL | Participants will receive teclistamab plus daratumumab plus lenalidomide plus bortezomib in 28-day cycles. |
| Japanese Participants with Relapsed or Refractory Multiple Myeloma (MM) | EXPERIMENTAL | Japanese participants will receive Teclistamab subcutaneously (SC) at four dose levels. Cohort 1 will receive Teclistamab at Dose 1 and 2 (step-up doses) prior to first treatment dose on Day 1 followed by Dose 3 weekly (that is, on Days 1,8, and 15 of a 21-day cycle). Cohort 2 will receive Teclistamab at Dose 1 and 4 (step up doses) prior to first treatment dose on Day 1 followed by Dose 5 weekly. Cohort 3 will receive Teclistamab at Dose 1, 4, and 5 (step up doses) prior to first treatment dose on Day 1 followed by Dose 6 weekly. Cohort 4 will receive Teclistamab at Dose 1, 4, and 5 (step up doses) prior to first treatment dose on Day 1 followed by Dose 7 weekly for (2 cycles), then biweekly (cycle 3 to 6) on Days 1 and 15 and monthly (cycle 7) on Day 1 of 1 28-day cycle. In Phase 2 , participants will receive Teclistamab SC at Dose 1 and 4 (step up doses) up to 8 days prior to first treatment dose on Day 1 followed by Dose 5 on Days 1,8,15, and 22 of a 28-day cycle. |
| Part 1: Dose Escalation (IV) | EXPERIMENTAL | Participants will receive Teclistamab intravenously (IV). |
| Part 2: Dose Expansion (IV) | EXPERIMENTAL | Participants will receive Teclistamab IV. |
| Part 1: Dose Escalation (SC) | EXPERIMENTAL | Participants will receive Teclistamab subcutaneously (SC). |
| Part 2: Dose Expansion (SC) | EXPERIMENTAL | Participants will receive Teclistamab SC. |
| Name | Type | Description |
|---|---|---|
| Teclistamab | DRUG | Teclistamab is administered as part of combination immunotherapy according to protocol-defined dosing and schedule in participants receiving maintenance treatment for multiple myeloma. |
| Talquetamab | DRUG | Talquetamab is administered in combination with teclistamab as part of maintenance immunotherapy according to protocol-defined dosing and schedule. |
| Daratumumab (Subcutaneously) | DRUG | Daratumumab is administered as part of standard maintenance therapy according to protocol-defined dosing and schedule in participants with multiple myeloma. |
| Lenalidomide | DRUG | Lenalidomide is administered as continuous maintenance therapy according to protocol-defined dosing and schedule in combination with daratumumab. |
| Pomalidomide | DRUG | Pomalidomide will be administered orally. |
| Bortezomib | DRUG | Bortezomib will be administered subcutaneously. |
| Dexamethasone | DRUG | Dexamethasone will be administered orally in PVd and intravenously or orally in Kd. |
| Carfilzomib | DRUG | Carfilzomib will be administered intravenously. |
| Daratumumab | DRUG | Daratumumab will be administered as SC injection. |
| teclistamab+daratumumab followed by talquetamab+daratumumab followed by duration treatment with daratumumab and lenalidomide extended/maintenance | DRUG | teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression. |
| melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by drug therapy | PROCEDURE | Subjects who are MRD-positive (a threshold of 10\^5) will receive a single melphalan (MEL)-based hematopietic stem cell transplantation (HSCT) followed by teclistamab+daratumumab followed by talquetamab+daratumumab each for 4 cycles followed by a 2-year fixed duration treatment with daratumumab and lenalidomide extended/maintenance therapy for a maximum of 24 cycles, or until myeloma progression. |
| Daratumumab and Hyaluronidase-fihj | DRUG | Daratumumab is an monoclonal antibody that targets the CD38 protein on the surface of myeloma cells. |
| Tocilizumab | DRUG | Tocilizumab will be administered as a pretreatment medication in advance of administration of the first step-up dose of teclistamab or talquetamab on Cycle 1 Day 1. |
| Oral Dexamethasone | DRUG | Oral dexamethasone will be administered as a pretreatment medication every 12 hours in 3 doses (PM/AM/PM) following each step-up dose and the first full dose of teclistamab in Cycle 1. A total of 9 doses of oral dexamethasone will be administered. |
| Nirogacestat | DRUG | Participants will receive nirogacestat. |
| Teclistamab (IV) | DRUG | Participants will receive IV infusion of Teclistamab. |
| Teclistamab(SC) | DRUG | Participants will receive SC injection of Teclistamab. |
Inclusion Criteria: 1. Documented diagnosis of MM as per IMWG diagnostic criteria. 2. Newly diagnosed patients who have completed a single or tandem autologous stem cell transplant after receiving quadruplet induction (containing an anti-CD38 antibody, an immunomodulatory drug, and a proteasome inh...
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Teclistamab is an investigational monoclonal antibody being studied in hematologic malignancies, including multiple myeloma, AL amyloidosis, Waldenstrom's macroglobulinemia, and high-risk smoldering multiple myeloma. It is a bispecific antibody that binds CD3 on T cells and TNFRSF17 (BCMA) on plasma cells, directing T cells against malignant plasma cells.
Teclistamab targets CD3E, CD3G, and CD3D on T cells and TNFRSF17, also known as BCMA, on plasma cells. By binding both, it forms a bridge that brings T cells into contact with BCMA-expressing myeloma cells, triggering T-cell-mediated killing of those cells.
Teclistamab is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is running clinical studies of teclistamab both as a single agent and in combinations, including with daratumumab and talquetamab, across plasma cell disorders.
Teclistamab is in clinical development and is not described as approved. Its registered studies include Phase 2 and Phase 3 trials. Four trials are listed, all currently active, with one completed, and total planned enrollment across these studies is approximately 1,938 patients.
Registered teclistamab trials include NCT07791498 in Waldenstrom's macroglobulinemia, NCT07740486 comparing teclistamab and talquetamab versus daratumumab and lenalidomide after stem cell transplant in multiple myeloma, NCT07110844 testing teclistamab plus daratumumab in AL amyloidosis, and NCT07029776 in high-risk multiple myeloma.