Frontline Combination CAR-T Cell Therapy for Multiple Myeloma or Plasmacytoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShenzhen Geno-Immune Medical Institute
About this trial
The aim of this clinical trial is to assess the feasibility, safety, and efficacy of CAR-T cell therapy targeting multiple cancer cell antigens in high-risk multiple myeloma or plasmacytoma as part of a frontline treatment regimen for patients. Another goal of the study is to learn more about the persistence and function of these CAR-T cells in the body.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female subjects with multiple myeloma or plasmacytoma
Strictly complete remission (sCR) is a treatment goal
Expected survival > 12 weeks
After prior auto-SCT is eligible regardless of other prior therapies
Disqualifiers
Pregnant or lactating women
Uncontrolled active infection
Active HIV, hepatitis B or hepatitis C infection
Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
Trial design
Design model
Single group
Treatments tested in this trial
CAR-T cells
Biological/VaccineInfusion of multi-CAR-T cells
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: CAR-T cells to treat MMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with treatment related adverse effects
The percentage of participants with treatment-related adverse events, as assessed by CTCAE v4.0
Time frame
1 monthSecondary outcomes
1
Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion
Anti-tumor activity of the fourth generation multiple CAR-T cells after infusion by measuring the CAR copies in the blood
Time frame
1 year2
Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma
Anti-tumor activity of fourth generation multiple CAR-T cells in patients with high-risk MM or plasmacytoma by examination of known tumor indicators
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: