Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06196255
Other study ID # XYFY2023-KL216-01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 25, 2023
Est. completion date January 1, 2028

Study information

Verified date December 2023
Source Xuzhou Medical University
Contact Kailin Xu, MD.,PD.
Phone 15162166166
Email lihmd@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.


Description:

This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date January 1, 2028
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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: 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 costimulation (<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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
anti-FcRL5 CAR-T
anti-FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy.

Locations

Country Name City State
China The affiliated hospital of Xuzhou Medical University Xuzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Adverse events assessed according to NCI-CTCAE v5.0 Baseline up to 28 days after CAR-T cells infusion
Secondary overall response rate (ORR) Assessment of ORR at Month 6, 12, 18 and 24 Month 6, 12, 18 and 24
Secondary complete response (CR) Assessment of CR at Month 6, 12, 18 and 24 Month 6, 12, 18 and 24
Secondary Overall survival (OS) Assessment of OS at Month 6, 12, 18 and 24 Month 6, 12, 18 and 24
Secondary Event-free survival (EFS) Assessment of EFS at Month 6, 12, 18 and 24 Month 6, 12, 18 and 24
See also
  Status Clinical Trial Phase
Recruiting NCT05027594 - Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02412878 - Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma Phase 3
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Recruiting NCT05971056 - Providing Cancer Care Closer to Home for Patients With Multiple Myeloma N/A
Recruiting NCT05243797 - Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone Versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation Phase 3
Active, not recruiting NCT04555551 - MCARH109 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of Multiple Myeloma Phase 1
Recruiting NCT05618041 - The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients With Hematological Malignancies N/A
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Completed NCT02916979 - Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG Phase 1
Recruiting NCT03570983 - A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03665155 - First-in- Human Imaging of Multiple Myeloma Using 89Zr-DFO-daratumumab, a CD38-targeting Monoclonal Antibody Phase 1/Phase 2
Completed NCT02812706 - Isatuximab Single Agent Study in Japanese Relapsed AND Refractory Multiple Myeloma Patients Phase 1/Phase 2
Active, not recruiting NCT05024045 - Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Phase 1
Active, not recruiting NCT03792763 - Denosumab for High Risk SMM and SLiM CRAB Positive, Early Myeloma Patients Phase 2
Active, not recruiting NCT03989414 - A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM) Phase 1/Phase 2
Withdrawn NCT03608501 - A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation Phase 2
Recruiting NCT04537442 - Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly Patients With Relapsed or Refractory Multiple Myeloma Phase 1
Completed NCT02546167 - CART-BCMA Cells for Multiple Myeloma Phase 1