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Trial Title:
Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma (R/R MM)
NCT ID:
NCT06196255
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Multiple Myeloma
FcRL5
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
anti-FcRL5 CAR-T
Description:
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.
Arm group label:
anti FcRL5 CAR-T
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.
Detailed 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.
Criteria for 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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The affiliated hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Zip:
221006
Country:
China
Status:
Recruiting
Contact:
Last name:
Kailin Xu, MD
Phone:
15162166166
Email:
lihmd@163.com
Start date:
December 25, 2023
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Xuzhou Medical University
Agency class:
Other
Source:
Xuzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06196255
