CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms and Lymphomas/Leukemias With Plasmacytic Differentiation

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAffiliated Hospital to Academy of Military Medical Sciences

About this trial

This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms and lymphomas/leukemias with plasmacytic differentiation.

Eligibility criteria

Qualifiers

Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry

Patients with multiple myeloma, plasma cell carcinoma, plasma cell leukemia and lymphomas/leukemias with plasmacytic differentiation who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse

Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past [anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)], but have failed or experienced relapse

Age 18-80 years, no gender restrictions

Disqualifiers

Severe heart failure with left ventricular ejection fraction <50%

A history of severe lung function impairment

Combined with other advanced malignant tumors

Complicated with severe infection that could not be effectively controlled

Trial design

Treatments tested in this trial

  • CAR19BCMA-T cells
  • fludarabine and cyclophosphamide

Treatment groups

20 Participants
are divided into 1 treatment group