CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms (NCT07077330) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
CAR19BCMA CAR-T Cells for the Treatment of R/R Plasma Cell Neoplasms
China20 participantsStarted 2025-08-01
Plain-language summary
This is a single arm study to evaluate the safety and efficacy of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19/BCMA positive plasma cell neoplasms.
Who can participate
Age range
18 Years – 75 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
. Relapsed/refractory CD19BCMA positive plasma cell neoplasms must be assured and meet all of the following conditions:
.1 Confirmation for either BCMA or CD19 positivity using immunohistochemistry or flow cytometry.
.2 Patients with multiple myeloma, plasma cell carcinoma, and plasma cell leukemia who have received at least three 3 lines treatment (including anti-CD38 monoclonal antibodies, protease inhibitors, immunosuppressants, etc.) but have failed or experienced relapse.
.3 Patients with system light chain amyloidosis who have received at least 2 lines treatments in the past \[anti-CD38 monoclonal antibody, proteasome inhibitor (PI), or immunomodulatory drug (IMiD)\], but have failed or experienced relapse.
. Age 18-75 years,
. no gender restrictions;
. ECOG score ≤ 2 points;
. Expected survival period is not less than 3 months;
Exclusion criteria
. Severe heart failure with left ventricular ejection fraction \<50%;
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
According to the incidence of treatment-related adverse events (AEs) to evaluate the safetyof CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+plasma cell neoplasms.
Timeframe: up to 3 years
2
According to the determine the Maximal Tolerable Dose(MTD) to evaluate the safety of CAR19BCMA CAR-T cells in the treatment of relapsed/refractory CD19+BCMA+ plasma cell neoplasms.
Timeframe: MTD will be determined based on DLTs observed during the first 28 days of study treatment
. A history of severe lung function impairment; Combined with other advanced malignant tumors;
. Complicated with severe infection that could not be effectively controlled;
. Severe autoimmune disease or congenital immune deficiency;
. Active viral hepatitis (defined as positive hepatitis B virus DNA \[HBV-DNA\] or hepatitis C virus RNA \[HCV-RNA\] detection, with test results exceeding the lower limit of quantification); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;
. History of severe allergy to biological products (including antibiotics);
. Allogeneic hematopoietic stem cell transplant patients who still have an acute graft-versus-host response (GVHD) one month after discontinuation of immunosuppressants;
. Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study;