CAR 70-BCMA CAR-T Cells for the Treatment of Relapsed or Refractory Plasma Cell Neoplasms
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe General Hospital of Western Theater Command
About this trial
This is a single arm study to evaluate the safety and efficacy of CAR70-BCMA dual-target CAR-T cell therapy for relapsed and refractory plasma cell neoplasms.
Eligibility criteria
Qualifiers
The subject or their legally authorized representative has provided written informed consent and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures
Clonal plasma cells positive for BCMA and/or CD70 expression as determined by flow cytometry or immunohistochemistry
Patients with multiple myeloma, plasmacytoma, or plasma cell leukemia who have received at least three prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody, and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR
Patients with systemic light chain amyloidosis who have received at least two prior lines of therapy, including an anti-CD38 monoclonal antibody and either a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD), and whose best response was less than partial response (PR) or who experienced disease progression after achieving at least PR
Disqualifiers
Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) < 50%
History of severe pulmonary function impairment
Concurrent progressive malignancy
Concurrent severe infection that cannot be adequately controlled
Trial design
Treatments tested in this trial
- CAR 70-BCMA CAR-T
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov