CM336 Plus Isa-VR in Newly Diagnosed Primary Plasma Cell Leukemia
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The goal of this clinical trial is to learn whether CM336, a BCMA/CD3 bispecific antibody, can improve treatment outcomes when combined with isatuximab, lenalidomide, and bortezomib in adults with newly diagnosed primary plasma cell leukemia (pPCL). The study will also evaluate the safety of this treatment combination. The main questions it aims to answer are: How many participants achieve minimal residual disease (MRD) negativity after 9 treatment cycles? What side effects occur during treatment with CM336 combined with isatuximab, lenalidomide, and bortezomib? How many participants respond to treatment, and how long do those responses last? How long do participants remain free from disease progression, and how long do they survive after starting treatment? All participants will receive the study treatment. There is no comparison group in this study. Participants will: Receive CM336 by subcutaneous injection together with isatuximab, lenalidomide, and bortezomib in 28-day treatment cycles. Undergo regular blood tests, bone marrow examinations, and disease assessments to monitor treatment response and safety. Have stem cells collected after the first 3 treatment cycles if appropriate. Continue treatment for up to 18 cycles, followed by maintenance treatment with isatuximab and lenalidomide until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision. Be monitored throughout the study for side effects.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 75 lat
- •Nowo rozpoznana białaczka z komórek osocza (bez poprzedniego leczenia lub po maksymalnie jednym cyklu leczenia)
- •Wymierny stan choroby potwierdzony badaniami krwi
- •Prawidłowe funkcjonowanie wątroby i nerek
- •Wystarczająca liczba białych krwinek, hemoglobiny i płytek krwi
- •Zdolność do zrozumienia i podpisania zgody na udział w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- September 18, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Trial contact
Gang An, PhD & MD
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/19/2026.
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