B Cell LymphomaEarly Phase 1NCT06976437
A Clinical Study of Allogeneic CD19/BCMA CAR-T Cells for the Treatment of R/R B-cell Malignant Tumors
A Early Phase 1 study testing RN1101 injection in people with B Cell Lymphoma and Multiple Myeloma, run by YANRU WANG at 1 site in China.
Trial summary
A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphoma, Multiple Myeloma
- What is being tested?
- RN1101 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2025to 30 Dec 2027
- Phase
- Early 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to participate in the trial and provision of signed informed consent.
- Patients diagnosed with B-lymphocyte or plasma cell-derived malignancies as per the 2017 revised WHO criteria, including acute B-lymphoblastic leukemia (B-ALL), and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), mantle cell lymphoma (MCL), multiple myeloma (MM), etc.
- Refractory or recurrent B-lymphocyte or plasma cell-derived malignancies, defined as failure to achieve complete remission after standard treatment, or relapse during follow-up after achieving remission with first-line or salvage therapy.
- Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).
- According to the revised International Working Group (IWG) criteria, relapsed/refractory lymphoma patients must have at least one measurable lesion with a longest diameter ≥1.5 cm.
- 18 Years and older, regardless of gender.
Show all 12Show fewer
- An expected survival of ≥12 weeks.
- Serum total bilirubin level < twice the upper limit of normal, serum creatinine level < upper limit of normal, serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < three times the upper limit of normal.
- Absolute neutrophil count ≥0.5×10⁹/L, platelets ≥20×10⁹/L; for B-lymphocyte malignancies with definitive bone marrow involvement, no requirements for neutrophil and platelet counts.
- ECOG performance status of 0 - 2.
- Left ventricular ejection fraction (LVEF) ≥50% and no pericardial effusion.
- At least 2 weeks have passed since the last treatment (radiotherapy, chemotherapy, monoclonal antibody therapy, or other treatments).
Who cannot join
- Known allergies, hypersensitivity, intolerance, or contraindications to CD19/BCMA allogenic CAR-T or any components of the trial drugs (including fludarabine, cyclophosphamide, and rituximab), or a history of severe allergic reactions.
- Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.
- Severe active infection.
- Acquired or congenital immunodeficiency.
- New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.
- History of epilepsy or other central nervous system diseases.
Show all 14Show fewer
- Lymphoma with extranodal involvement of the brain, lungs, or gastrointestinal tract.
- Other primary cancers, except:
- Non-melanoma skin cancer (e.g., basal cell carcinoma) cured by resection.
- Carcinoma in situ (e.g., cervical, bladder, or breast cancer) cured.
- Systemic high-dose steroids within 2 weeks before treatment.
- Pregnant, breastfeeding, or plans to become pregnant within 6 months.
- Participation in another clinical trial within the past month.
- Any situation the investigator deems may raise risks or interfere with 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
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001
Xiaoming Fei, PhD, 086-1381512462752, feixiaomingujs@aliyun.com
About this study
Official title: An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CD19/BCMA CAR-T Cell Treatment for Relapsed/ Refractory B-cell or Plasma Cell-derived Malignant Tumors
A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.
- Conditions
- B Cell Lymphoma, Multiple Myeloma
- Being tested
- RN1101 injection
- Medical subject headings
- Lymphoma, B-Cell, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RN1101 injectionDrug
RN1101 injection is an allogenic CAR-T targeted CD19 and BCMA. A single infusion of CAR-T cells will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| RN1101 treatment | Experimental | CD19+ or BCMA+ r/r B Cell lymphoma or multiple myeloma (MM) patients to be treated with a single dose of RN1101 cells. Receives: Drug: RN1101 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events after RN1101 infusion
Measured: up to 24 weeks after RN1101 infusion
Secondary outcomes (6)
Percentage of MRD negative patients after RN1101 treatment
Measured: 12 weeks, 24 weeks after RN1101 infusion
ORR (PR, VGPR, CR and sCR) of patients receive RN1101 treatment
Measured: 12 weeks, 24 weeks after RN1101 infusion
Progression free survival after RN1101 treatment
Measured: 12 weeks, 24 weeks after RN1101 infusion
CAR copies and cell count of CAR-T in blood and bone marrow (if available) after RN1101 treatment
Measured: 12 weeks, 24 weeks after RN1101 infusion
Duration of response after RN1101 treatment
Measured: 12 weeks, 24 weeks after RN1101 infusion
Overall survival after RN1101 treatment
Measured: 12 weeks, 24 weeks after RN1101 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start6 May 2025
- Primary completion20 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell LymphomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YANRU WANG
- Sponsor type
- University, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd, Allorunning Therapeutics
- Responsible party
- Sponsor-investigator, YANRU WANG, Affiliated Hospital of Jiangsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976437
- Sponsor's protocol ID
- RunNing
- Status last verified
- Jul 2025
- First submitted
- 9 May 2025
- Last updated
- 10 Jul 2025
- 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 10 Jul 2025. 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 Allogeneic CD19/BCMA CAR-T Cell Treatment for Relapsed/ Refractory B-cell or Plasma Cell-derived Malignant Tumors
- ClinicalTrials.gov ID
- NCT06976437
- Acronym / sponsor ID
- RunNing
- Conditions
- B Cell Lymphoma, Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- YANRU WANGUniversity, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd, Allorunning Therapeutics
- Study start
- 6 May 2025 (actual)
- Primary completion
- 20 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 May 2025 (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.
A single arm, open-label pilot study is designed to determine the safety and efficacy of CD19 and B-cell maturation antigen (BCMA) targeted allogenic CAR-T cells (RN1101) in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors. 21 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study is to evaluation of the safety and feasibility of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The secondary objective is to evaluate the efficacy of RN1101 for the treatment of relapsed/refractory B-cell or plasma cell-derived malignant tumors. The exploratory objective is to evaluate expansion, persistence and ability of RN1101 to deplete CD19 or BCMA positive cells in patients with relapsed/refractory B-cell or plasma cell-derived malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RN1101 treatment | Experimental | Drug: RN1101 injectionCD19+ or BCMA+ r/r B Cell lymphoma or multiple myeloma (MM) patients to be treated with a single dose of RN1101 cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Willingness to participate in the trial and provision of signed informed consent.
- Patients diagnosed with B-lymphocyte or plasma cell-derived malignancies as per the 2017 revised WHO criteria, including acute B-lymphoblastic leukemia (B-ALL), and mature B-cell lymphomas such as diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma/chronic lymphocytic leukemia (SLL/CLL), mantle cell lymphoma (MCL), multiple myeloma (MM), etc.
- Refractory or recurrent B-lymphocyte or plasma cell-derived malignancies, defined as failure to achieve complete remission after standard treatment, or relapse during follow-up after achieving remission with first-line or salvage therapy.
- Patients with B-cell acute lymphoblastic leukemia (ALL) who have achieved hematologic remission but have persistent minimal residual disease (MRD).
- According to the revised International Working Group (IWG) criteria, relapsed/refractory lymphoma patients must have at least one measurable lesion with a longest diameter ≥1.5 cm.
Key exclusion criteria (14 listed)
- Known allergies, hypersensitivity, intolerance, or contraindications to CD19/BCMA allogenic CAR-T or any components of the trial drugs (including fludarabine, cyclophosphamide, and rituximab), or a history of severe allergic reactions.
- Recurrence after allogeneic hematopoietic stem cell transplantation with active graft - versus - host disease (GVHD) requiring steroid or immunosuppressive therapy.
- Severe active infection.
- Acquired or congenital immunodeficiency.
- New York Heart Association (NYHA) Class Ⅲ or Ⅳ heart failure.
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 |
|---|---|---|
| RN1101 injectionRN1101 injection is an allogenic CAR-T targeted CD19 and BCMA. A single infusion of CAR-T cells will be administered intravenously. | Drug | RN1101 treatment |
Primary outcome
Incidence and severity of adverse events after RN1101 infusion
Time frame: up to 24 weeks after RN1101 infusion
6 secondary outcomes
Percentage of MRD negative patients after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
ORR (PR, VGPR, CR and sCR) of patients receive RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
Progression free survival after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
CAR copies and cell count of CAR-T in blood and bone marrow (if available) after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
Duration of response after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
Overall survival after RN1101 treatment
Time frame: 12 weeks, 24 weeks after RN1101 infusion
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 10 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for B Cell Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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 Early Phase 1 study testing RN1101 injection in people with B Cell Lymphoma and Multiple Myeloma, run by YANRU WANG 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 12 inclusion and 14 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 10 Jul 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Xiaoming Fei (+86-1381512462752, feixiaomingujs@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events after RN1101 infusion (time frame: up to 24 weeks after RN1101 infusion). 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 10 Jul 2025.