Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of this study is evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D) (Part 3).

Official Title

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

Details

The corresponding study (NCT03145181) is the Phase 1 part of the study and TECLIMMY1001- Part 3 is the Phase 2 part of the study.

Keywords

Hematological Malignancies Multiple Myeloma Hematologic Neoplasms Teclistamab

Eligibility

You can join if…

Open to people ages 18 years and up

-

  • 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 or are double refractory to an immunomodulatory imide drug (IMiD) and protease inhibitor (PI) Prior therapy must include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort B: received at least 4 prior MM treatment lines of therapies and whose disease is penta-refractory to at least 2 PIs, at least 2 IMiDs, and an anti-CD38 monoclonal antibody; Cohort C: received treatment with chimeric antigen receptor (CAR)-T therapy directed against B cell maturation antigen (BCMA) or an antibody drug conjugate (ADC)

You CAN'T join if...

  • Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
  • The following cardiac conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV), hepatitis B or C, 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 day (PI or radiotherapy within 14 day, IMiDs within 7 day ) prior to first dose of study drug
  • Received a cumulative dose of corticosteroids equivalent to >= 140 milligram (mg) of prednisone within the 14-day period before the first dose of study drug
  • Toxicities from previous anticancer therapies that 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)
  • Active malignancies with exceptions are: 1) Non-muscle invasive bladder cancer. 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
  • Known active CNS involvement or exhibits clinical signs of meningeal involvement of MM

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • Stanford University Medical Center
    Stanford California 94305-5623 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT04557098
Phase
Phase 2
Study Type
Interventional
Last Updated