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Tests treatment safety and results for Multiple Myeloma
Official title Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)
ClinicalTrials.gov ID: NCT06196255
What this study is testing
What is anti-FcRL5 CAR-T?
anti-FcRL5 CAR-T 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
- This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture.
- 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 70
You may be able to join if
- The set subject include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell...
- Age is 18\~70 years old;
- Expected survival period of\>12 weeks;
- Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;
- Patients with refractory multiple myeloma;
You likely can't join if
- Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
- Infectious diseases (such as HIV, active tuberculosis, etc.);
- Active hepatitis B or hepatitis C infection;
- Feasibility assessment screening demonstrated \<10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation...
- Abnormal vital signs, and unable to cooperate with the examination;
- Have mental or mental illness who cannot cooperate with the treatment and how well it works evaluation;
See the full eligibility criteria
- The set subject include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (\<2 years) with existing therapies, as...
- Age is 18\~70 years old;
- Expected survival period of\>12 weeks;
- Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;
- Patients with refractory multiple myeloma;
- Patients with multiple myeloma recurrence;
- ALT and AST \<3 times normal; bilirubin \<2.0mg / dl;
- Quality of survival score (KPS)\> 50%;
- The patient has no serious heart, liver, kidney and other diseases;
- Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;
- Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;
- Blood can be obtained intravenously, without other contraindications to leukapheresis;
- Understand and voluntarily sign a written informed consent form.
- Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
- Infectious diseases (such as HIV, active tuberculosis, etc.);
- Active hepatitis B or hepatitis C infection;
- Feasibility assessment screening demonstrated \<10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (\<5-fold);
- Abnormal vital signs, and unable to cooperate with the examination;
- Have mental or mental illness who cannot cooperate with the treatment and how well it works evaluation;
- Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;
- people with a systemic infection or a severe local infection requiring anti-infective treatment;
- people with severe autoimmune disease;
- The doctor believes there were other reasons for inclusion
The study team makes the final eligibility decision.
Where it's taking place
- Xuzhou, Jiangsu, 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xuzhou, Jiangsu, 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.