Universal CAR-T Cells Targeting Multiple Myeloma
ConditionMultiple Myeloma in Remission
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShenzhen Geno-Immune Medical Institute
About this trial
The aim of this study is to assess the feasibility, safety and efficacy of universal CAR T cells targeting multiple myeloma. Another goal of the study is to learn more about the persistence and function of the universal CAR T cells in the body.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with confirmed multiple myeloma failed curative treatment options (including autologous or allogeneic SCT).
Complete remission (CR) cannot be achieved after at least 2 prior therapy regimens.
High risk MM in CR1 or CR2 and not eligible for SCT because of age or comorbid diseases.
Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year).
Disqualifiers
Pregnant or lactating women
Uncontrolled active infection
Active 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
MM-specific universal CAR T cells
Biological/VaccineInfusion of MM-specific universal CAR T cells
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Universal CART cells to treat MMExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with treatment related adverse effect
percentage of participants with treatment-related adverse events, as assessed by physical examination, vital signs, standard clinical lab tests.
Time frame
6 monthsSecondary outcomes
1
Anti-tumor activity of the universal 4SCAR-T cells after infusion
CART cells in the peripheral blood of patients will be measured by qPCR on Day 7, 14, 21, 28, 60 and 90 after infusion.
Time frame
3 months2
Anti-tumor activity of fourth generation universal CAR-T cells in patients with relapsed or refractory MM
Objective response, such as complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD) will be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
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: