BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma (NCT05376345) | Clinical Trial Compass
TerminatedPhase 1
BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma
Stopped: Per sponsor request
China24 participantsStarted 2022-09-01
Plain-language summary
This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCDR cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
. Subjects ≥ 18 years of age.
. Documented initial diagnosis of MM according to IMWG diagnostic criteria.
. Presence of measurable disease at screening.
. Received a PI and an IMiD (except thalidomide).
. Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Timeframe: Minimum 2 years after LCAR-BCDR infusion (Day 1)
2
Recommended Phase 2 dose (RP2D) finding
Timeframe: 30 days after LCAR-BCDR infusion (Day 1)
3
CAR positive T cells in peripheral blood and bone marrow
Timeframe: Minimum 2 years after LCAR-BCDR infusion (Day 1)
4
CAR transgene levels in peripheral blood and bone marrow
Timeframe: Minimum 2 years after LCAR-BCDR infusion (Day 1)
. No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment).
. Prior treatment with any antibody targeting BCMA.
. Diagnosed or pretreated for an invasive malignancy other than multiple myeloma.
. Prior anti-tumor treatment (before pretreatment) with insufficient washout period.
. Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma.
. Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening.
. Serious underlying medical conditions
. Male subjects who have a birth plan during the study period or within 1 year after the study treatment.