Multiple MylomaPhase 1NCT07652138
Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
A Phase 1 study testing BCMA/CD19-targeted allogeneic CAR-T in people with Multiple Myloma and Newly Diagnosed Multiple Myeloma (NDMM), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myloma, Newly Diagnosed Multiple Myeloma (NDMM)
- What is being tested?
- BCMA/CD19-targeted allogeneic CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Nov 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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:
- Resected non-melanoma (e.g., basal cell carcinoma)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Xiaowen Tang, 13913538266, tangxiaowen@suda.edu.cn
About this study
Official title: An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
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.
- Being tested
- BCMA/CD19-targeted allogeneic CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA/CD19-targeted allogeneic CAR-TDrug
Lymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic CAR-T cell therapy | Experimental | Newly Diagnosed Multiple Myeloma Patients are treated with allogeneic CAR-T cell therapy Receives: Drug: BCMA/CD19-targeted allogeneic CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs)
Measured: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.
Secondary outcomes (5)
Overall effectiveness and duration of efficacy
Overall response rate (ORR) and complete response rate (CR), negative rate of MRD (detected by flow cytometry or NGS)
Measured: 4 weeks, 3 months, 6 months, and 12 months
Pharmacokinetic (PK) of RN1201
Levels of RN1201 CAR-positive T cells in the blood and/or bone marrow
Measured: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Levels of Peripheral blood M protein
Measured: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Levels of urine M protein
Measured: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Levels of Peripheral blood cytokines
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start30 Jul 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MylomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652138
- Sponsor's protocol ID
- 2025510
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No