Studieninformationen
Kurztitel:
TECLIMMY 10001-P3,JNJ-64007957MMY1001
Beschreibung:
A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a
Humanized BCMA x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory
Multiple Myeloma
Studiendesign:
Phase I/II, , Multizentrisch, International
Therapielinien:
Alter:
>= 18 Jahre
Erkrankungen:
Ein-/Ausschlusskriterien:
Inclusion Criteria: - Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 Measurable disease: Multiple myeloma must be measurable by central laboratory assessment Women of childbearing potential must have a negative pregnancy test at screening Willing and able to adhere to the prohibitions and restrictions specified in this protocol Cohort A: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort C: received >= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC) Exclusion Criteria: Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction <= 6 m, stage III-IV congestive heart failure, etc) Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3 Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug Toxicities from previous anticancer therapies that have not resolved to baseline or to <= grade 1 (except for alopecia or peripheral neuropathy) Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication) Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM) Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence Prior allogenic stem cell transplant <=6 months Prior autologous stem cell transplant <=12 weeks Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
common:study_status_active
Universitätsklinikum Würzburg
97080 Würzburg
Medizinische Klinik II, Schwerpunkt Hämatologie/Onkologie
Herr Prof. Dr. Stefan Knop
Knop_S@ukw.de
Frau Linda Heimberg
Heimberg_L1@ukw.de