About this trial
The goal of this clinical trial is to evaluate the efficacy of Teclistamab (Te) and autologous lymphocyte infusions (ALI) in relapse refractory multiple myeloma. The main question it aims to answer is: which is the Duration of response (DoR) with Teclistmab and ALI?
Participants will receive Te for 5 cycles. Participants in PR or better after the first five cycles of Te monotherapy will continue treatment with Te in combination with ALI administration starting from cycle 6
Eligibility criteria
Qualifiers
• Patient has a confirmed diagnosis of MM according to the WHO 2022 classification (18)
Patient age is ≥ 18 years of age
Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease by the International Myeloma Working Group (IMWG) (15) criteria >60 days after cessation of treatment
Refractory disease is defined as failure to achieve a response or confirmed progressive disease by IMWG criteria (15) during previous treatment or ≤60 days after cessation of treatment.
Disqualifiers
• Previous treatment with > 2 lines of therapy
Patient has active central nervous system involvement with MM
Received any prior BCMA-directed therapy
Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less
Trial design
Treatments tested in this trial
- Teclistamab