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New treatment option for Relapsed/Refractory Multiple Myeloma(MM)
Official title LCAR-F33S in Treatment of Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT07100067
What this study is testing
What is LCAR- F33S cells intravenous infusion?
LCAR- F33S cells intravenous infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed/refractory multiple myeloma(mm).
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
- A prospective, single-arm, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-F33S in patients with relapsed/refractory multiple myeloma(Investigator-initiated Study).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people voluntarily participate in clinical research.
- Age ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) score 0-2.
- Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria.
- Measurable lesions were present.
You likely can't join if
- Received previous therapy targeting FcRH5 targets.
- Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
- people had Plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
- people who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
- Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are...
- Serious underlying diseases were present.
See the full eligibility criteria
- people voluntarily participate in clinical research.
- Age ≥18 years old.
- Eastern Cooperative Oncology Group (ECOG) score 0-2.
- Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria.
- Measurable lesions were present.
- people have received treatment with one PI, one IMiD and a CD38 monoclonal antibody.
- people have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression...
- Expected survival ≥3 months.
- Clinical laboratory values in the screening period meet criteria.
- Received previous therapy targeting FcRH5 targets.
- Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
- people had Plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
- people who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
- Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
- Serious underlying diseases were present.
- Female people who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
- Also enrolled in other clinical studies.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Tianjin, China
- Wuhan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Tianjin, China; Wuhan, 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.