BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChongqing Precision Biotech Co., Ltd
About this trial
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed written informed consent;
Failed to standard chemotherapy regimens;
Relapse after complete remission, high-risk and / or refractory patients ;
Relapse after hematopoietic stem cell transplantation;
Disqualifiers
Previous history of other malignancy;
Presence of uncontrolled active infection;
Evidence of disorder that need the treatment by glucocorticoids;
Active or chronic GVHD；
Trial design
Design model
Single group
Treatments tested in this trial
BCMA CAR-T cells
Biological/VaccineBCMA CAR-T cell therapy
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: BCMA CAR-T cells treatExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time frame
2 years2
The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy
The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG
Time frame
2 yearsSecondary outcomes
1
Rate of BCMA CAR-T cells in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) rate of BCMA CAR-T cells were determined by means of flow cytometry
Time frame
2 years2
Quantity of BCMA CAR copies in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) quantity of BCMA CAR copies were determined by means of qPCR
Time frame
2 years3
Quantity of clonal plasma cells in bone marrow
In vivo (bone marrow) quantity of clonal plasma cells
Time frame
1 years4
Levels of Cytokines in Serum
In vivo (Serum) quantity of cytokines
Time frame
1 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov