Safety and Efficacy of APRIL-BAFF-Bicephali CAR-T in Relapsed, Refractory Multiple Myeloma

NCT06132711 | Recruiting Phase 1

• 1 other identifier: XYFY2023-KL144-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Myeloma

Keywords

myeloma, Chimeric antigen receptor, April, TACI

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events assessed according to NCI-CTCAE v5.0

  :Baseline up to 28 days after CAR-T cells infusion]

Secondary Outcomes (4)

• overall response rate (ORR)

  Month 6, 12, 18 and 24

• complete response (CR)

  Month 6, 12, 18 and 24

• Overall survival (OS)

  Month 6, 12, 18 and 24

• Event-free survival (EFS)

  Month 6, 12, 18 and 24

Study Arms (1)

Patients treated with CAR T cells

EXPERIMENTAL

Peripheral blood mononuclear cells were collected and subjected to CD3+T cells were enriched, transfected with APRIL-BAFF-Bicephali lentiviral vector, expanded by in vitro culture, and pretreated with clear lymphocytes using the FC protocol before infusion of APRIL-BAFF-Bicephali CAR-T cells.

Other: APRIL-BAFF-Bicephali CAR-T cells

Interventions

APRIL-BAFF-Bicephali CAR-T cells OTHER

Peripheral blood mononuclear cells were collected and subjected to CD3+T cells were enriched, transfected with APRIL-BAFF-Bicephali lentiviral vector, expanded by in vitro culture, and pretreated with clear lymphocytes using the FC protocol before infusion of APRIL-BAFF-Bicephali CAR-T cells.

Patients treated with CAR T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Xuzhou Medical University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

Kailin Xu

Xuzhou, Jiangsu, 221000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kailin Xu MD, PD

  The Affiliated Hospital oh Xuzhou Medical University

  STUDY CHAIR

Central Study Contacts

Kailin Xu MD, PD

CONTACT

15162166166; lihmd@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: November 15, 2023
• Study Start: November 10, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)