Dual-target BCMA-GPRC5D CAR-T Cell Therapy for RR/MM With Extramedullary Infiltration
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing GoBroad Hospital
About this trial
This is a multicenter, open-label, non-randomized, single-arm clinical trial. Patients with relapsed/refractory multiple myeloma accompanied by extramedullary infiltration will receive BCMA - GPRC5D CAR-T cell therapy.
The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and GPRC5D CAR - T cell therapy for extramedullary infiltration in relapsed/refractory multiple myeloma. The primary endpoints are to assess the type and incidence of dose-limiting toxicity (DLT) within one month after the reinfusion of BCMA-GPRC5D CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the reinfusion. It is expected that no more than 18 participants will be recruited.
Eligibility criteria
Qualifiers
Voluntarily participate in the trial and have good compliance.
Aged between 18 and 75 years old, regardless of gender.
Diagnosed with relapsed or refractory multiple myeloma according to the criteria of the International Myeloma Working Group (IMWG)2, and have measurable extramedullary lesions due to multiple myeloma.
Positive for BCMA and GPRC5D in flow cytometry of bone marrow or cerebrospinal fluid tumor cells or immunohistochemistry of tumor tissue.
Disqualifiers
Pregnant or lactating women.
Active infections that have not been effectively controlled.
Active autoimmune diseases that have not been effectively controlled.
Adverse reactions caused by previous treatments have not recovered to CTCAE grade ≤ 1.
Trial design
Treatments tested in this trial
- Dual-targeting BCMA-GPRC5D CAR-T cell infusion
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov