First-line RN1201 CAR-T for newly diagnosed multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this single-arm Phase 1 trial, patients with newly diagnosed multiple myeloma receive lymphodepletion followed by a single infusion of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy. The study uses a dose-escalation approach to characterize safety and tolerability, with secondary measures including overall response rate and minimal residual disease status. Primary endpoints focus on treatment-emergent adverse events, while secondary endpoints assess response depth. Participants must meet predefined organ function and performance status criteria and have confirmed BCMA-positive MM. The trial is conducted at The First Affiliated Hospital of Soochow University in Suzhou, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Xiaowen Tang
• Email: tangxiaowen@suda.edu.cn
• Phone: 13913538266

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fewer-doses daratumumab added to VRd for newly diagnosed multiple myeloma

  This study tests whether a less-frequent daratumumab dosing plan added to VRd can help patients with newly diagnosed multiple myeloma achieve more MRD negativity.

  Recruiting Phase 2 Tata Memorial Centre · Navi Mumbai, Maharashtra and 1 other locations · NCT07891923

• AZD0120 consolidation vs ASCT in transplant-eligible newly diagnosed multiple myeloma

  This study tests whether AZD0120 given as consolidation can work as well as or better than traditional autologous stem cell transplant in transplant-eligible patients with newly diagnosed multiple myeloma.

  Recruiting at 2 sites Phase 3 AstraZeneca · Gilbert, Arizona and 113 other locations · NCT07735637

• First-line immunotherapy in Chinese adults with newly diagnosed multiple myeloma

  This study will test how first-line immunotherapy treatments—including anti-CD38 antibodies, proteasome inhibitors, and IMiDs—work in adults newly diagnosed with multiple myeloma in China over one year.

  Recruiting Peking University People's Hospital · Beijing, Beijing Municipality · NCT07296627

• Combining PET scans and bone marrow genetic testing to better predict relapse in newly diagnosed multiple myeloma patients

  This project tries combining FDG PET/LDCT imaging and whole-exome sequencing of bone marrow to detect minimal residual disease and better predict progression for transplant-eligible newly diagnosed multiple myeloma patients.

  Recruiting at 4 sites Universiteit Antwerpen · Antwerp, Antwerpen and 3 other locations · NCT07087964

• Using 18F-fluciclovine PET/CT to detect multiple myeloma

  This study is testing a new imaging method using a special tracer to see if it can better detect multiple myeloma in adults compared to the current method.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06103838

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.