Evaluating a new CAR-T 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 clinical trial is designed to assess the safety and efficacy of APRIL-BAFF-Bicephali CAR-T cells in patients with relapsed and refractory multiple myeloma. The study involves a single-center, open-label approach where patients undergo leukocyte apheresis for CAR-T cell preparation, followed by chemotherapy to reduce tumor load before receiving the CAR-T cell transfusion. Participants will be monitored during the inpatient phase and will have long-term follow-up to evaluate treatment outcomes. The trial aims to provide insights into a novel immunotherapy approach for a challenging cancer.

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:

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 co-stimulation (\<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

• Kailin Xu
  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.

• BCMA-TGFβ CAR-T Cells in Relapsed or Refractory Myeloma

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  Recruiting Phase 1 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT05976555

• CAR-T therapy outcomes and quality of life in older adults with B‑cell lymphoma

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• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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

  This observational study tests how patients with multiple myeloma respond to cilta-cel treatment by tracking toxicities and trying to spot biomarkers to guide care.

  Recruiting at 3 sites Icahn School of Medicine at Mount Sinai · San Francisco, California and 2 other locations · NCT07665307

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

  This trial will test a BCMA-targeted CAR-T cell therapy that secretes a PD-1 antibody and interleukin-21 fusion protein as consolidation treatment for people with multiple myeloma who have kidney dysfunction.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07489534

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

  This trial will test whether adding a personalized DC/MM fusion vaccine (with GM‑CSF) to standard BCMA CAR‑T therapy helps people with relapsed or refractory multiple myeloma.

  Recruiting Phase 1 Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT07377435

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.