IL-15-Armored CAR-T Therapy in Relapsed or Refractory Multiple Myeloma and Plasma Cell Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Hospital of Jilin University
About this trial
This is an open-label, single-arm, Phase 2 study to evaluate the efficacy and safety of IL-15-armored chimeric antigen receptor T-cell (CAR-T) therapy in subjects with relapsed or refractory multiple myeloma and plasma cell leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to provide written informed consent and comply with the scheduled visits, study treatment, laboratory assessments, and other study procedures.
Clinically diagnosed relapsed or refractory multiple myeloma or plasma cell leukemia (PCL). Patients with persistent minimal residual disease (MRD) positivity or conversion from MRD-negative to MRD-positive status following induction and consolidation therapy are also eligible for enrollment.
Age 18 to 80 years, inclusive.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
Disqualifiers
New York Heart Association (NYHA) Class III or IV heart failure;
Myocardial infarction;
Cardiac angioplasty or stent placement;
Unstable angina;
Trial design
Design model
Single group
Treatments tested in this trial
IL-15-armored CAR-T cells
Biological/VaccineBCMA-targeted: 1.0/1.5/2.0 × 10\^6 CAR-T cells; CD19/BCMA dual-targeted: 1.0/1.5/2.0 × 10\^6 CAR-T cells; GPRC5D-targeted: 1.0/2.0/3.0 × 10\^6 CAR-T cells.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: IL-15 armored CAR-T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR)
Percentage of participants with presence of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). ORR assessment will be based on International Myeloma Working Group (IMWG) response criteria.
Time frame
From infusion to 12 monthsSecondary outcomes
1
Complete Response Rate
Percentage of participants who achieved CR or sCR according to IMWG Uniform Response Criteria for Multiple Myeloma
Time frame
From infusion to 12 months2
MRD-negative rate
Achieving measurable residual disease (MRD) negativity, as determined by multiparameter flow cytometry (MFC) or next-generation sequencing (NGS) after CAR-T cells infusion.
Time frame
From infusion to 12 months3
CR/MRD-negative rate
Percentage of participants who achieved both CR and MRD negativity with a sensitivity of 10\^-4 or better within 12 months post infusion.
Time frame
From infusion to 12 months4
Time to Response
Time from infusion to first documentation of response of PR or better.
Time frame
From infusion to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov