Clinical trial · Interventional
Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myloma | — | UNRESOLVED | — |
| Newly Diagnosed Multiple Myeloma (NDMM) | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA/CD19-targeted allogeneic CAR-T | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Allogeneic CAR-T cell therapy
- description
- Newly Diagnosed Multiple Myeloma Patients are treated with allogeneic CAR-T cell therapy
- interventionNames
- Drug: BCMA/CD19-targeted allogeneic CAR-T
Primary outcomes (1)
- measure
- The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs)
- timeFrame
- DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.
Secondary outcomes (5)
- measure
- Overall effectiveness and duration of efficacy
- timeFrame
- 4 weeks, 3 months, 6 months, and 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.References
Publications (0)
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