Status:
RECRUITING
Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma
Lead Sponsor:
Xuzhou Medical University
Collaborating Sponsors:
Yake Biotechnology Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 ...
Detailed Description
This trial is a single-center, open, single-arm trial with a non-blinded design. The study consisted of four processes: patient enrollment screening; pre-CAR T cell therapy (including leukocyte apher...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Exclusion criteria
- Women who are pregnant or breastfeeding, or who have a pregnancy plan within six months;
- Infectious diseases (such as HIV, active tuberculosis, etc.);
- Active hepatitis B or hepatitis C infection;
- Feasibility assessment screening demonstrated \<10% transfection of targeted lymphocytes or underamplification under CD3 / CD28 co-stimulation (\<5-fold);
- Abnormal vital signs, and unable to cooperate with the examination;
- 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;
- The doctor believes there were other reasons for inclusion.
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06132711
Start Date
November 10 2023
End Date
January 1 2027
Last Update
November 15 2023
Active Locations (1)
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1
Kailin Xu
Xuzhou, Jiangsu, China, 221000