NCT06196255RecruitingPhase 1/2
Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)
Efficacy and Safety Study of Anti-FcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 9 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 25 Dec 2023
- Start date
- 25 Dec 2023
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Xuzhou Medical University
- Diseases
- Multiple myeloma
- NCT number
- NCT06196255
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 20
- From 25 Dec 2023 to the primary completion date, 1 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Infectious diseases (such as HIV, active tuberculosis, etc.);
- Active hepatitis B or hepatitis C infection;
- Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;
- Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;
- Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;
- Subjects with severe autoimmune disease;
Lab values
- Feasibility assessment screening demonstrated \<10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (\<5-fold);
Other
- Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
- Abnormal vital signs, and unable to cooperate with the examination;
- The doctor believes there were other reasons for inclusion
Who the study is looking for
- The set subject inclusion criteria 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 follows:
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.