BridgeMD
New treatment option for Multiple Myeloma
Official title Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT06581640
What this study is testing
What is CAR-T treatment?
CAR-T treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age 18-80 years, no gender restrictions;
- Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
- Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
- As judged by the investigator, the expected survival time is \>3 months;
- ECOG performance status score ≤2, KPS \>60%;
You likely can't join if
- Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
- Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
- History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of...
- Previously received treatment targeting BCMA;
- Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
- Presence of uncontrolled active bacterial or fungal infection;
See the full eligibility criteria
- Age 18-80 years, no gender restrictions;
- Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
- Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
- As judged by the investigator, the expected survival time is \>3 months;
- ECOG performance status score ≤2, KPS \>60%;
- The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin \ 30 mL/min; heart ejection fraction (EF) ≥40%, no...
- Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10\^9/L, PLT \>30×10\^9/L, Hb \>80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;
- Those with fertility must agree to use highly effective contraceptive methods;
- The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.
- Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
- Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
- History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);
- Previously received treatment targeting BCMA;
- Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
- Presence of uncontrolled active bacterial or fungal infection;
- Allergic to research-related drugs or cell components;
- Presence of active autoimmune diseases;
- Currently have unstable or active ulcers or gastrointestinal bleeding;
- Unable to cooperate with treatment and how well it works evaluation due to mental or psychological disorders;
- Received other experimental drug treatments within the last 3 months;
- The researcher believes that for other reasons, the individual is not suitable for the clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.