Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
Recruiting
Phase 1
Interventional Study
Multiple Myloma
Newly Diagnosed Multiple Myeloma (NDMM)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 18 (estimated)
- Sponsor
- The First Affiliated Hospital of Soochow University · Other
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About This Trial
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 re…
Trial Locations
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Eligibility Criteria
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 yea…
Contacts