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Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Cancer Type
Multiple Myeloma
Trial Phase
Phase I
18 Years and older, Male and Female
Study Type
Protocol IDs
CR108206 (primary)
Study Sponsor
Janssen Research & Development, LLC


The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule
assessed to be safe for Teclistamab and to characterize the safety and tolerability of
Teclistamab at the RP2Ds.


The study will be conducted in 2 parts, separately for IV and SC administration: dose
escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability,
pharmacokinetics and preliminary antitumor activity of Teclistamab administered to adult
participants with relapsed or refractory multiple myeloma. The overall safety of the study
drug will be assessed by physical examinations, Eastern Cooperative Oncology Group
performance status, laboratory tests, vital signs, electrocardiograms, adverse event
monitoring, and concomitant medication usage. Disease evaluations will include peripheral
blood and bone marrow assessments at screening (performed within 28 days) and to confirm
stringent complete response (sCR), complete response (CR), or relapse from CR. The end of
study (study completion) is defined as 2 years after the last participant in Part 3 has
received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of
this study and study record NCT03145181 is Phase 1 part of this study.


  1. Documented diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
  2. Measurable multiple myeloma that is relapsed or refractory to established therapies with known clinical benefit in relapsed/refractory multiple myeloma or be intolerant of those established multiple myeloma therapies, and a candidate for Teclistamab treatment in the opinion of the treating physician. Prior lines of therapy must include a proteasome inhibitor, an immunomodulatory drug and anti-CD38 monoclonal antibody in any order during the course of treatment. Participants who could not tolerate a proteasome inhibitor or immunomodulatory drugs and an anti-CD38 monoclonal antibody are allowed
  3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  4. Female participants of childbearing potential must use acceptable method of contraception
  5. Participants must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard-of-care for the participant's disease
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.