In Vivo BCMA/GPRC5D Tandem Dual CAR-T Therapy for Relapsed/Refractory Plasma Cell Neoplasms

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLiping Dou

About this trial

This study aims to assess the safety profile of in vivo BCMA/GPRC5D-targeted CAR-T cell immunotherapy in patients with relapsed or refractory plasma cell neoplasms.

Eligibility criteria

Qualifiers

Voluntary signing of informed consent by the subject or legally authorized representative, with willingness and ability to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.

Clonal plasma cells confirmed to be BCMA and/or GPRC5D positive by flow cytometry or immunohistochemistry;

Previously treated with at least 2 lines of anti-plasma cell neoplasms therapy, with at least 1 complete treatment cycle for each line, and evidence of disease progression within 12 months after the most recent anti-plasma cell neoplasms treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-plasma cell neoplasms treatment (according to the IMWG diagnostic criteria)

Age 18 to 75 years (inclusive), male or female.

Disqualifiers

Severe cardiac dysfunction with left ventricular ejection fraction (LVEF) < 50%.

History of severe pulmonary impairment.

Concurrent diagnosis of another active malignancy.

Uncontrolled active infection.

Trial design

Treatments tested in this trial

  • In vivo BCMA/GPRC5D Tandem Dual CAR-T cell

Treatment groups

18 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Liping Dou

Lead sponsor

Chinese PLA General Hospital

Sponsor institution