A Study of Anti-BCMA CAR-T Therapy in Newly Diagnosed Myeloma Patients Who Are Transplant-ineligible
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuzhou Medical University
About this trial
This is a prospective study of anti-BCMA CAR-T in transplant-ineligible patients with newly diagnosed multiple myeloma.
Eligibility criteria
Qualifiers
Age between 18 and 70 years (inclusive);
Estimated life expectancy of more than 12 weeks;
Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);
Disqualifiers
Pregnant or lactating women, or women planning to become pregnant within the next six months;
Transduction efficiency of targeted lymphocytes <10%, or expansion fold <5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);
Significant dysfunction of vital organs including the heart, lungs, or brain;
Trial design
Treatments tested in this trial
- CAR-T
Treatment groups
35 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov