Dual-target BCMA-CD19 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 - CD19 CAR-T cell therapy.
The primary objective is to prospectively evaluate the safety of dual-targeting BCMA and CD19 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 infusion of BCMA-CD19 CAR-T cells in patients, as well as the incidence and severity of adverse events within one month after the infusion. It is expected that no more than 18 participants will be recruited.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 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
Design model
Single group
Treatments tested in this trial
Dual-targeting BCMA-CD19 CAR-T cell infusion
DrugApproximately 3-5 days prior to BCMA-CD19 CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Dual-targeting BCMA-CD19 CAR-T cell therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose-limiting toxicity (DLT)
Incidence and type of dose-limiting toxicity(DLT) within 1 month of BCMA-CD19 CAR-T infusion.
Time frame
30 days2
Adverse events (AEs）
Total number, incidence and severity of adverse events (AEs) within 30 days of BCMA-CD19 CAR-T infusion
Time frame
30 daysSecondary outcomes
1
Overall remission rate (ORR)
The assessment of ORR by dose group at 90 Days after BCMA-CD19 CAR-T infusion.
Time frame
90 days2
Event Free Survival (EFS)
Evaluate the EFS of dual-targeting BCMA-CD19 CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Time frame
from enrollment to the end of treatment at 2 years3
Duration of Response (DOR)
Evaluate the DOR of dual-targeting BCMA-CD19 CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Time frame
from enrollment to the end of treatment at 2 years4
Overall Survival (OS)
Evaluate the OS of dual-targeting BCMA-CD19 CAR-T cell therapy for extramedullary infiltration in relapsed and refractory multiple myeloma
Time frame
from enrollment to the end of treatment at 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov