talquetamab clinical trials

The recall period is 7 days ("past week"), and responses are reported using a verbal and numeric rating scales. Titers of ADAs to talquetamab will be reported. VGPR or better response rate is defined as percentage of participants with best overall response of VGPR or better according to IMWG criteria. K. Marcinkowskiego w Poznaniu, Narodowy Instytut Onkologii im. You have reached the maximum number of saved studies (100). Talquetamab will be administered as subcutaneous injection. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Participants assigned to Treatment regimen B will receive talquetamab SC in combination with daratumumab SC and carfilzomib as an IV infusion. van de Donk, MD, a hematologist at the VU University Medical Center in Amsterdam, The Netherlands, said in a virtual presentation during the meeting. Study record managers: refer to the Data Element Definitions if submitting registration or results information. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Home. Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. Number of participants with anti-drug antibodies to daratumumab will be reported for treatment regimens B and D. Number of participants with anti-drug antibodies to rHuPH20 will be reported. talquetamab is a potential first-in-class, investigational t-cell redirecting bispecific antibody targeting both gprc5d, a novel multiple myeloma target that does not shed over time, and cd3, a. Here we report updated and new results of talquetamab at the recommended phase 2 doses (RP2Ds) from a phase 1 trial in relapsed/refractory MM (RRMM; NCT03399799). NCT03399799 Recruiting . sCR rate is defined as the percentage of participants who achieve an sCR according to the IMWG 2016 criteria. Teclistamab will be administered as a SC injection. ICH GCP. Initial clinical results from the phase 1b multicohort TRIMM-2 study identified the recommended phase 2 doses (RP2Ds) and support the combination of tal plus dara for the treatment of RRMM, with manageable safety, no overlapping toxicities, and promising . Why Should I Register and Submit Results? MCT Tags; NDMM Trials; RRMM Trials; MGUS/SMM Trials; Phase 3 Trials; Phase 2 Trials; Phase 1/2 Trials; Phase 1 . Clinical trial information: NCT03399799. Why Should I Register and Submit Results? If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required, Live, attenuated vaccine within 4 weeks before the first dose of study treatment, Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade] or peripheral neuropathy to Grade <= 2), Received a cumulative dose of corticosteroids equivalent to >= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration. Multiple myeloma is the most common disease being investigated in talquetamab clinical trials [ 2 ]. PFS is defined as time from date of first dose of study drug to date of first documented PD, per IMWG criteria, or death due to any cause, whichever occurs first. Talquetamab, an off-the-shelf T-cell redirecting, GP3C5D-targeting agent, has continued to show promising clinical activity in patients with relapsed/refractory multiple myeloma, especially. Information provided by (Responsible Party): The purpose of this study is to compare the efficacy of talquetamab versus belantamab mafodotin in terms of overall response rate (ORR) or progression-free survival (PFS). The binding of both activates the immune system to attach the myeloma cells. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05461209. The item and scale scores are transformed to a 0 to 100 scale. Teclistamab is a humanized IgG4PAA bispecific antibody designed to target B cell maturation antigen (BCMA) and the CD3 molecule found on T cells. Talquetamab. Daratumumab (dara) is an anti-CD38 mAb with direct on-tumor and immunomodulatory actions. The development of the antibody followed Janssen Biotech, Inc.'s licensing agreement with Genmab for use of its DuoBody technology platform. Duration of response is defined as time from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG 2016 criteria, or death due to disease progression, whichever occurs first. The EORTC-QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea/vomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). US Clinical Trials Registry Kliniske forsg Nct side Virkning af tidlig mobilisering p opholdets lngde, genopretning og tilbagetagelseshastighed for patienter efter CABG eller AVR / MVR-kirurgi Talquetamab (JNJ-64407564) is a bispecific IgG4 antibody that redirects T-cell killing to multiple myeloma cells by binding to the novel target, GPRC5D, and CD3. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. This clinical trial will not involve giving patients a placebo drug. A high scale score represents a higher response level. This was for talquetamab, which again targets this specific anchor. You can use your HealthTree data to see if you qualify to join a talquetamab trial. The EQ-5D-5L is a 5-item questionnaire that assesses 5 domains including mobility, self-care, usual activities, pain/discomfort and anxiety/depression plus a visual analog scale rating "health today" with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). View duration, location, compensation, and staffing details. The EuroQol 5-Dimension Questionnaire 5-Level (EQ-5D-5L) is a generic measure of health status. Talquetamab Monotherapy Shows Early Promise in Relapsed/Refractory Multiple Myeloma. Individual Participant Data (IPD) Sharing Statement: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. Information provided by (Responsible Party): The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor. CR or better response is defined as percentage of participants with best overall response of CR or better according to IMWG criteria. Talquetamab is a humanized IgG4PAA bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. He reviewed the latest results of this study, which explores the synergistic effect of combining talquetamab (Tal) with . Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05338775. Brief Summary: The purpose of this study is to identify recommended Phase 2 doses (RP2Ds) for each treatment combination (between daratumumab plus talquetamab and teclistamab plus daratumumab with or without pomalidomide) and to characterize the safety of each RP2D for selected treatment combinations. This study will investigate the possible improvement of ORR or PFS with talquetamab compared with belantamab mafodotin in participants with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 mAb (alone or in combination), and whose disease is refractory to at least one proteasome inhibitor (PI) and one immunomodulatory drug (IMiD). Clinical Trial Page A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma A Phase 3 Study Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma Who Have Received at Least 4 Prior Therapies Including an Immunomodulatory Drug, a . Belantamab Mafodotin will be administered as intravenous infusion. ORR is defined as the percentage of participants who achieve partial response (PR) or better according to the International Myeloma Working Group (IMWG) 2016 criteria. Description Details Talquetamab (JNJ-64407564) is a bispecific antibody binds to both CD3 on T cells and GPRC5D expressed on certain tumor cells. Talquetamab has been investigated in 3 clinical trials, of which 3 are open and 0 are closed. Daratumumab will be administered subcutaneously. Other clinical pearls, according to Aronson, include certain dietary modifications and early treatment of oral candida. More info . Total duration of study is up to 2 years 5 months. Other Name: JNJ-64407564 Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talquetamab is a first-in-class investigational bispecific antibody targeting both GPRC5D, a novel multiple myeloma target, and CD3, the T-cell receptor. VGPR or better response rate is defined as the percentage of participants who achieve a VGPR or better response (stringent complete response [sCR]+ complete response [CR]+VGPR) according to the IMWG 2016 criteria. Talquetamab is a humanized IgG4PAA bispecific antibody designed to target G protein-coupled receptor family C group 5-member D (GPRC5D) and the CD3 molecule found on T lymphocytes (T cell). Multiple myeloma is a malignant plasma cell disorder characterized by osteolytic lesions, increased susceptibility to infections, hypercalcemia, and renal failure.Overall rationale of study is that daratumumab in combination with talquetamab or teclistamab may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The study will be conducted in 2 parts: dose escalation and dose expansion. For general information, Learn About Clinical Studies. Of the trials investigating talquetamab, 2 are phase 1 (2 open) and 1 is phase 2 (1 open). Ajai Chari, MD, discusses the safety and efficacy of talquetamab plus daratumumab in heavily pretreated patients with multiple myeloma, initial data from phase 1b TRIMM-2 trial, and the potential . . Why Should I Register and Submit Results? ClinicalTrials.gov Identifier: NCT05338775, Interventional Talquetamab (JNJ-64407564) is a first-in-class bispecific IgG4 antibody that redirects T cells to kill MM cells by binding to both GPRC5D and CD3 receptors. Participants will receive IV infusion or SC injection of Talquetamab at each putative recommended Phase 2 dose(s) (RP2D[s]) as determined in Part 1. If either is suspected, whole body magnetic resonance imaging (MRI) and lumbar cytology are required. ClinicalTrials.gov Identifier: NCT03399799, Interventional Participants will receive IV infusion or SC injection of Talquetamab. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05503550. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory . Primary objectives of part 1 of the trial was identification of the RP2D whereas safety and tolerability were the objectives of part 2. Talquetamab (JNJ-64407564) is a first-in-class bispecific antibody that binds to GPRC5D and CD3 to induce T cell-mediated killing of GPRC5D-expressing MM cells through the recruitment and activation of T cells. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Clinical Trials on Talquetamab. Participants assigned to Treatment regimen A will receive talquetamab subcutaneously (SC) in combination with carfilzomib as an intravenous (IV) infusion. DB16678. Please remove one or more studies before adding more. (Clinical Trial), A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma, Experimental: Part 1: Dose Escalation (Talquetamab) - Intravenous (IV), Experimental: Part 1: Dose Escalation (Talquetamab) - Subcutaneous (SC), Experimental: Part 2: Dose Expansion (Talquetamab), 18 Years and older (Adult, Older Adult), Birmingham, Alabama, United States, 35294, Nashville, Tennessee, United States, 37203, Centre Hospitalier Universitaire de Liege Domaine Universitaire du Sart Tilman, Janssen Research & Development, LLC Clinical Trial. The overall rationale of this study is that talquetamab or teclistamab in combination with a PD-1 inhibitor may lead to enhanced clinical responses in treatment of relapsed or refractory multiple myeloma through multiple mechanisms of action. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Talk with your doctor and family members or friends about deciding to join a study. Belantamab mafodotin is a humanized B-cell maturation antigen (BCMA)-targeting monoclonal antibody (mAb) conjugated to a cytotoxic agent maleimidocaproyl monomethyl auristatin F (MMAF) which disrupts the microtubule network, leading to cell cycle arrest and apoptosis. Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. NCT04773522 Recruiting . Choosing to participate in a study is an important personal decision. Serum samples will be analyzed to determine concentrations of talquetamab. Talquetamab is used to treat Multiple Myeloma and will not be given with a placebo. Number of participants with clinically significant abnormalities in laboratory parameters such as hematology and serum chemistry will be reported. Universitaria Senese- Ospedale Santa Maria alle Scotte, Azienda Ospedaliera Universitaria Citt della Salute e della Scienza di Torino, ASST Sette Laghi, Ospedale di Circolo e Fondazione Macchi, Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. The agent targets the novel biomarker GPRC5D on multiple myeloma cells and CD3 on T-cells. about the author Vicki Jones . Genetic and Rare Diseases Information Center, A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma. Ongoing Clinical Trials. This is because Talquetamab has previously been approved by the FDA for a different condition. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Intervention Details: Drug: Talquetamab Talquetamab will be administered subcutaneously (SC). Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarkers will be assessed at specified time points. [3] CD3 is involved in activating T-cells, and GPRC5D is highly expressed on multiple myeloma cells. June 29, 2022 (RARITAN, N.J.) - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least 4 prior lines of therapy, including a proteasome . Genetic and Rare Diseases Information Center, U.S. Department of Health and Human Services. talquetamab is a first-in-class, investigational t-cell redirecting bispecific antibody targeting both gprc5d, a novel multiple myeloma target that does not shed over time, and cd3, the t-cell receptor. . In a phase 1 clinical trial (MagnetisMM-1 trial, NCT03269136), 58 patients with RRMM received weekly subcutaneous . Multiple myeloma is a malignant plasma cell disorder that accounts for approximately 10 percent (%) of all hematologic cancers, making it the second most common hematologic malignancy. 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. Serum cytokine concentrations will be measured pre- and post-infusion of Talquetamab for biomarker assessment. Talquetamab (JNJ-64407564) Talquetamab (JNJ-64407564) is the first bispecific IgG4 antibody targeting GPRC5D on MM cells and CD3 on T cells (56, 57). Pomalidomide will be self-administered orally. Clinical Trial Information: NCT03399799 . Serum samples will be analyzed to determine concentrations of Talquetamab using validated, specific, and sensitive immunoassay methods. Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to AE. For general information, Learn About Clinical Studies. In preclinical studies, talquetamab induced activation and degranulation of T . As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu, https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu, https://www.janssen.com/clinical-trials/transparency. Listing a study does not mean it has been evaluated by the U.S. Federal Government. PFS2 is defined as time from randomization to progression on the first subsequent line of therapy or death due to any cause, whichever comes first. For general information, Learn About Clinical Studies. Updated Phase 1 Results from MonumenTAL-1: First-in-Human Study of Talquetamab, a G Protein-Coupled Receptor Family C Group 5 Member D x CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Multiple Myeloma . Serum samples will be analyzed to determine concentrations of daratumumab for treatment regimens B and D. Number of participants with anti-drug antibodies to talquetamab will be reported. GPRC5D has limited expression on healthy human tissue but is highly expressed on malignant myeloma cells. Pillarisetti K, Edavettal S, Mendona M, Li Y, Tornetta M, Babich A, Majewski N, Husovsky M, Reeves D, Walsh E, Chin D, Luistro L, Joseph J, Chu G, Packman K, Shetty S, Elsayed Y, Attar R, Gaudet F. A T-cell-redirecting bispecific G-protein-coupled receptor class 5 member D x CD3 antibody to treat multiple myeloma. 2020 Apr 9;135(15):1232-1243. doi: 10.1182/blood.2019003342. U.S. Department of Health and Human Services. Study record managers: refer to the Data Element Definitions if submitting registration or results information. US Clinical Trials Registry; EU Clinical Trials Registry . Generic Name. Part 2: Participants with multiple myeloma measurable by central laboratory assessment who have progressed on, or could not tolerate, all available established therapies; Serum monoclonal paraprotein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL) or urine M-protein level >=200 milligram per 24 hours (mg/24 h) or light chain multiple myeloma without measurable disease in the serum or the urine: serum immunoglobulin free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio; If central laboratory assessments are not available, relevant local laboratory measurements must exceed the minimum required level by at least 25%, Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, Women of childbearing potential must have a negative pregnancy test at screening and prior to the first dose of study drug using a highly sensitive pregnancy test either serum (Beta human chorionic gonadotropin [beta-hCG]) or urine, Sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, and is willing to and able participate in the study. Serum samples will be analyzed to determine concentrations of talquetamab using a validated, specific, and sensitive electrochemiluminescent immunoassay (ECLIA) method. B. Markiewicza, Swietokrzyskie Centrum Onkologii SPZOZ w Kielcach, Szpital Kliniczny im. ClinicalTrials.gov Identifier: NCT05503550, Pre-Approval Access Single Patient Request Treatment for Talquetamab for Treating Physician Use in Relapsed or Refractory Multiple Myeloma, 18 Years and older (Adult, Older Adult), Janssen Research & Development, LLC Clinical Trial. Listing a study does not mean it has been evaluated by the U.S. Federal Government. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu. This trial will study whether talquetamab can help treat people with multiple myeloma that has gotten worse after other treatments or that never responded to other treatments. EQ-5D-5L is a generic measure of health status. Official Title: A Phase 3 Randomized Study Comparing Talquetamab in Combination With Daratumumab (SC) and Pomalidomide (Tal-DP) or Talquetamab (SC) in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [TimeFrame:Up to 1 year and 10 months], Number of Participants with AEs by Severity [TimeFrame:Up to 1 year and 10 months], Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters [TimeFrame:Up to 1 year and 6 months], Number of Participants with Dose Limiting Toxicity (DLT) [TimeFrame:Up to 49 days], Overall Response Rate (ORR) [TimeFrame:Up to 1 year and 10 months], Very Good Partial Response (VGPR) or Better Response Rate [TimeFrame:Up to 1 year and 10 months], Complete Response (CR) or Better Response Rate [TimeFrame:Up to 1 year and 10 months], Stringent Complete Response (sCR) [TimeFrame:Up to 1 year and 10 months], Duration of Response [TimeFrame:Up to 1 year and 10 months], Time to Response [TimeFrame:Up to 1 year and 10 months], Serum Concentration of Talquetamab [TimeFrame:Up to 1 year and 10 months], Serum Concentration of Daratumumab [TimeFrame:Up to 1 year and 10 months], Number of Participants with Anti-Drug Antibodies to Talquetamab [TimeFrame:Up to 1 year and 10 months], Number of Participants with Anti-Drug Antibodies to Daratumumab [TimeFrame:Up to 1 year and 10 months], Number of Participants with Anti-Drug Antibodies to Recombinant Human Hyaluronidase PH20 Enzyme (rHuPH20) [TimeFrame:Up to 1 year and 10 months], Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria, Have measurable disease at screening as defined by at least 1 of the following: a. Serum monoclonal protein (M-protein) level greater than or equal to (>=) 1.0 gram per deciliter (g/dL); or b. Urine M-protein level >= 200 milligrams (mg)/24 hours; or c. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio, Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening and immediately before the start of study treatment administration, A woman of childbearing potential must have a negative highly sensitive serum beta human chorionic gonadotropin (beta-hCG) pregnancy test at screening and a negative urine or serum pregnancy test within 24 hours before the start of study treatment administration, Be willing and able to adhere to the lifestyle restrictions specified in the protocol, including adherence to the applicable immunomodulatory drug (IMiD) global Pregnancy Prevention Plan (PPP) or local PPP/Risk Evaluation and Mitigation Strategy (REMS) program, Live, attenuated vaccine within 4 weeks before the first dose of study treatment, Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the start of study treatment administration, Active central nervous system (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma.

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