NCT07032129 Sequential CAR-T Cells Targeting BCMA/GPRC5D in Patients With Relapsed/ Refractory Multiple Myeloma
| NCT ID | NCT07032129 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Essen Biotech |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2027-12-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2025-04-29 with a primary completion date of 2027-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or GPRC5D or both sequentially in the treatment of Relapsed/ Refractory Multiple myeloma
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07032129 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 90 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07032129 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07032129 currently recruiting?
Yes, NCT07032129 is actively recruiting participants. Contact the research team at clinical-trials@essen-biotech.com for enrollment information.
Where is the NCT07032129 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07032129 clinical trial?
NCT07032129 is sponsored by Essen Biotech. The trial plans to enroll 60 participants.