BCMA/CD19-targeted allogeneic CAR-T: Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Recruiting
More The First Affiliated Hospital of Soochow University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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