Evaluating a new CAR-T therapy for relapsed multiple myeloma

Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma-A Single-center, Open-label, Single-arm Clinical Study

This study is testing a new CAR-T therapy to see if it can help people with relapsed multiple myeloma feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Xuzhou Medical University (Academic / other)
• Drugs / interventions: immunotherapy, CAR-T, CAR T, chemotherapy, cyclophosphamide, fludarabine
• Locations: 1 site (Xuzhou, Jiangsu)
• Trial ID: NCT06132711 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with relapsed or refractory multiple myeloma and limited treatment options.

Not a fit: Patients with serious comorbidities or those who are not suitable for CAR-T cell therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could offer a new treatment option for patients with limited effective therapies for multiple myeloma.

How similar studies have performed: Other studies have shown promise with CAR-T therapies in hematological malignancies, suggesting potential for success with this novel approach.

Eligibility criteria

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 this trial is running

Xuzhou, Jiangsu

• Kailin Xu — Xuzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Kailin Xu MD, PD

Conditions Multiple Myeloma; myeloma, Chimeric antigen receptor, April, TACI