Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma

Launched by ESSEN BIOTECH · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for people with a type of blood cancer called multiple myeloma, specifically for patients whose cancer has come back or has not responded to standard treatments. The treatment uses a special kind of immune therapy called CAR-T cells, which are immune cells changed in the lab to better recognize and attack cancer cells. In this study, patients will receive CAR-T cells that target either one or two specific markers on the cancer cells, called BCMA and GPRC5D, given one after the other to see if this approach is safe and helps control the cancer.

To join the trial, patients need to have relapsed or refractory multiple myeloma and have already tried standard treatments without success. They should be expected to live at least three more months and have adequate heart, liver, and kidney health. People with certain infections, other serious health problems, or who are pregnant cannot join. Participants will be closely monitored for side effects and to see how well the treatment works. This trial is currently recruiting adults of all genders, and it offers hope for patients who have few other treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Expected survival time ≥3 months;
• • Subjects with recurrent/refractory Multiple Myeloma who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.
• • Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.
• * Liver and kidney function, cardiopulmonary function meet the following requirements:
• • Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;
• • Blood oxygen saturation \>91% in non-oxygen state;
• • Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.
• • No serious mental disorders;
• • Can understand this test and has signed the informed consent.
• Exclusion Criteria:
• • Malignant tumors other than R/R AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
• • Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;
• • Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;
• • Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;
• • Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;
• • Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;
• • Patients who received CAR-T therapy or other gene-modified cell therapy before screening;
• • Participated in other clinical studies 1 month before screening;
• • Evidence of central nervous system invasion during subject screening;
• • Mental patients with depression or suicidal thoughts;
• • Situations considered unsuitable for inclusion by other researchers.