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Tests treatment safety and results for Multiple Myloma
Official title Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
ClinicalTrials.gov ID: NCT07652138
What this study is testing
What is BCMA/CD19-targeted allogeneic CAR-T?
BCMA/CD19-targeted allogeneic CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myloma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- Patients with serious active infections.
- 2\. people with acquired or congenital immunodeficiency.
- 3\. people with Class III/IV heart failure per NYHA criteria.
- 4\. people with epilepsy or other central nervous system diseases.
- 5\. people with a history of primary cancer, except:
- Resected non-melanoma (e.g., basal cell carcinoma)
See the full eligibility criteria
- 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.
- Patients with serious active infections.
- 2\. people with acquired or congenital immunodeficiency.
- 3\. people with Class III/IV heart failure per NYHA criteria.
- 4\. people with epilepsy or other central nervous system diseases.
- 5\. people with a history of primary cancer, except:
- Resected non-melanoma (e.g., basal cell carcinoma)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.