Comparing ASCT Followed by Anti-BCMA CAR-T vs. ASCT Alone in NDMM Patients Eligible for ASCT

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuzhou Medical University

About this trial

This is a prospective study comparing autologous hematopoietic stem cell transplantation followed by anti-BCMA CAR-T to autologous hematopoietic stem cell transplantation alone in the treatment of newly diagnosed multiple myeloma patients.

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

  • autologous stem cell transplantation
  • CAR-T

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators