Multiple Myloma, Newly Diagnosed Multiple Myeloma (NDMM)
Conditions
Brief summary
This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma. Patients will receive lymphodepletion followed by a single infusion of RN1201. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.
Interventions
Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Willingness to participate in the trial and provide written informed consent. * 2\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria. * 3\. BCMA-positive multiple myeloma documented at screening or in prior medical records. * 4\. Aged 18 - 70 years, any gender. * 5\. Life expectancy of at least 12 weeks. * 6\. Serum total bilirubin \< twice the upper limit of normal (ULN); serum creatinine within normal range; * 7\. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< three times ULN. * 8\. ECOG performance status score of 0 - 2. * 9\. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion. * 10\. Ability to adhere to the study visit schedule and protocol requirements.
Exclusion criteria
1. Patients with serious active infections. * 2\. Subjects with acquired or congenital immunodeficiency. * 3\. Subjects with Class III/IV heart failure per NYHA criteria. * 4\. Subjects with epilepsy or other central nervous system diseases. * 5\. Subjects with a history of primary cancer, except: 1. Resected non-melanoma (e.g., basal cell carcinoma) 2. Cured carcinoma in situ (e.g., cervical, bladder, breast cancer) * 6\. Systemic high-dose steroid use within 2 weeks before treatment. * 7\. Pregnant, breastfeeding women, or those planning pregnancy in 6 months. * 8\. Participation in other clinical trials within one month. * 9\. Major surgery within 14 days before the first study drug dose. * 10\. Any condition the investigator deems may raise subject risks or affect trial results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs) | DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall effectiveness and duration of efficacy | 4 weeks, 3 months, 6 months, and 12 months | Overall response rate (ORR) and complete response rate (CR), negative rate of MRD (detected by flow cytometry or NGS) |
| Pharmacokinetic (PK) of RN1201 | Up to 52 weeks | Levels of RN1201 CAR-positive T cells in the blood and/or bone marrow |
| Pharmacodynamic (PD) of RN1201 | Up to 52 weeks | Levels of Peripheral blood M protein |
Countries
China
Contacts
CONTACTXiaowen Tang
Outcome results
None listed