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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07652138
- Acronym / sponsor ID
- 2025510
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic CAR-T cell therapy | Experimental | Drug: BCMA/CD19-targeted allogeneic CAR-TNewly Diagnosed Multiple Myeloma Patients are treated with allogeneic CAR-T cell therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willingness to participate in the trial and provide written informed consent.
Key exclusion criteria (12 listed)
- Patients with serious active infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCMA/CD19-targeted allogeneic CAR-TLymphodepletion chemotherapy followed by allogeneic CAR-T cell (RN1201) infusion | Drug | Allogeneic CAR-T cell therapy |
Primary outcome
The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs)
Time frame: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.
5 secondary outcomes
Overall effectiveness and duration of efficacy
Time frame: 4 weeks, 3 months, 6 months, and 12 months
Pharmacokinetic (PK) of RN1201
Time frame: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Time frame: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Time frame: Up to 52 weeks
Pharmacodynamic (PD) of RN1201
Time frame: Up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myloma
Not yet recruiting
Role of Uromodulin in Management of Multiple Myloma
Multiple Myloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Tang (13913538266, tangxiaowen@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs) (time frame: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.