Using Anti-FcRL5 CAR-T Cell Therapy for Relapsed Multiple Myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open label, single-arm Phase 2 study evaluates the safety and efficacy of Anti-FcRL5 CAR-T cell therapy in patients with relapsed and refractory multiple myeloma. Participants will undergo a leukapheresis procedure to manufacture CAR-modified T cells, followed by lymphodepleting therapy with fludarabine and cyclophosphamide before receiving the CAR-T infusion. The study aims to observe dose-limiting toxicity and determine the maximum tolerated dose to inform future treatment plans.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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:

1. Age is 18\~70 years old;
2. Expected survival period of\>12 weeks;
3. Multiple myeloma was diagnosed by physical examination, pathological examination, laboratory examination and imaging;
4. Patients with refractory multiple myeloma;
5. Patients with multiple myeloma recurrence;
6. ALT and AST \<3 times normal; bilirubin \<2.0mg / dl;
7. Quality of survival score (KPS)\> 50%;
8. The patient has no serious heart, liver, kidney and other diseases;
9. Recurrence or no disease remission after hematopoietic stem cell transplantation or cellular immunotherapy;
10. Is not suitable for stem cell transplantation conditions or to abandon transplantation due to conditional restrictions;
11. Blood can be obtained intravenously, without other contraindications to leukapheresis;
12. Understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
2. Infectious diseases (such as HIV, active tuberculosis, etc.);
3. Active hepatitis B or hepatitis C infection;
4. Feasibility assessment screening demonstrated \<10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 costimulation (\<5-fold);
5. Abnormal vital signs, and unable to cooperate with the examination;
6. Have mental or mental illness who cannot cooperate with the treatment and efficacy evaluation;
7. Highly allergic constitution or have a history of severe allergies, especially allergic to IL-2;
8. Subjects with a systemic infection or a severe local infection requiring anti-infective treatment;
9. Subjects with severe autoimmune disease;
10. The doctor believes there were other reasons for inclusion

Where it's running

• The affiliated hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Kailin Xu, MD.,PD.
• Email: lihmd@163.com
• Phone: 15162166166

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Understanding CAR-T Toxicities After Cilta-Cel in Multiple Myeloma

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• PD-1Ab21-BCMA CAR-T consolidation for multiple myeloma with renal dysfunction

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• DC/MM fusion vaccine plus BCMA CAR-T for relapsed or refractory multiple myeloma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.