NCT06132711 Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma
| NCT ID | NCT06132711 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Xuzhou Medical University |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-10 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-11-10 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Single-center, open, single-arm clinical study, the goal of which was to evaluate the safety and efficacy of APRIL-BAFF-Bicephali CAR-T in relapsed and refractory multiple myeloma.The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apheresis, CAR T cell preparation and chemotherapy); inpatient monitoring phase for CAR T cell transfusion; and long-term follow-up phase
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.
Contact & Investigator
Kailin Xu MD, PD
STUDY CHAIR
The Affiliated Hospital oh Xuzhou Medical University
Frequently Asked Questions
Who can join the NCT06132711 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06132711 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06132711 currently recruiting?
Yes, NCT06132711 is actively recruiting participants. Contact the research team at lihmd@163.com for enrollment information.
Where is the NCT06132711 trial being conducted?
This trial is being conducted at Xuzhou, China.
Who is sponsoring the NCT06132711 clinical trial?
NCT06132711 is sponsored by Xuzhou Medical University. The principal investigator is Kailin Xu MD, PD at The Affiliated Hospital oh Xuzhou Medical University. The trial plans to enroll 20 participants.