Relapsed or Refractory B-cell Hematologic MalignanciesPhase 1NCT07113496
RN1201injection for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
A Phase 1 study testing Allogeneic CAR-T in people with Relapsed or Refractory B-cell Hematologic Malignancies and B-cell Acute Lymphoblastic Leukemia (B-ALL), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-cell Hematologic Malignancies, B-cell Acute Lymphoblastic Leukemia (B-ALL), Multiple Myeloma (MM)
- What is being tested?
- Allogeneic CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation with signed informed consent.
- Pathologically confirmed CD19-positive and/or B-cell maturation antigen (BCMA)-positive hematologic malignancy according to the WHO 2017 classification, including but not limited to multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), mature B-cell lymphomas, and plasmablastic lymphoma.
- Relapsed/refractory disease defined as failure to achieve complete remission after standard therapy, or relapse after an initial response during treatment or follow-up.
- Measurable disease required:
- For B-ALL: persistent minimal residual disease (MRD) positivity despite hematologic remission.
- For lymphoma: at least one measurable lesion ≥1.5 cm in longest diameter per IWG revised criteria.
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- For multiple myeloma: positive immunofixation electrophoresis or presence of extramedullary disease.
- Age ≥18 years; both sexes eligible.
- Expected survival ≥12 weeks.
- Adequate organ function (exceptions for disease-related impairment are at the investigator's discretion):
- Total bilirubin <2× upper limit of normal (ULN); serum creatinine <ULN; ALT and AST <3× ULN.
- Absolute neutrophil count ≥0.5×10⁹/L; platelets ≥20×10⁹/L (no requirement if marrow involvement is documented).
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
- Left ventricular ejection fraction (LVEF) ≥50%.
Who cannot join
- Known hypersensitivity, allergy, intolerance, or contraindication to CD19/BCMA-UCAR-T or any study drugs (fludarabine, cyclophosphamide, tocilizumab).
- Genetic syndromes: Fanconi, Kostmann, Shwachman, or any documented bone-marrow failure syndrome.
- Active or uncontrolled infection requiring IV antibiotics; evidence of severe active infection.
- NYHA Class III or IV heart failure (unless clearly secondary to the underlying malignancy).
- Central Nervous System (CNS) disorders unrelated to the primary hematologic malignancy.
- Prior malignancy except adequately treated carcinoma in situ of skin, cervix, lung, or other non-active tumors.
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- Significant bleeding diathesis (e.g., gastrointestinal (GI) bleeding, coagulopathy, hypersplenism).
- History of significant cardiac disease within the past 3 months that, in the investigator's judgment, renders the patient unable to tolerate study participation..
- Pregnancy, lactation, or planned pregnancy within 6 months.
- Any condition that, in the investigator's opinion, may increase risk or interfere with study 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
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
Lei Fan, 086+025-68306124, fanlei@jsph.org.cn
Lei Fan
About this study
Official title: An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CAR-T Cell (RN1201) for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.
Read the detailed description
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status.Primary endpoints include treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), pharmacokinetics, and pharmacodynamics of UCAR-T. This study aims to provide initial evidence for the safety and anti-tumor activity of UCAR-T in CD19+/BCMA+ hematologic malignancies.
- Conditions
- Relapsed or Refractory B-cell Hematologic Malignancies, B-cell Acute Lymphoblastic Leukemia (B-ALL), Multiple Myeloma (MM), Plasmablastic Lymphoma, Relapsed or Refractory CD19+/BCMA+ Hematologic Malignancies, Mature B-Cell Lymphoma
- Being tested
- Allogeneic CAR-T
- Medical subject headings
- Recurrence, Burkitt Lymphoma, Multiple Myeloma, Plasmablastic Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic CAR-TBiological
Patients will receive lymphodepletion chemotherapy followed by a single intravenous infusion of Allogeneic CAR-T cells. In select cases, CAR-T infusion may be administered post-autologous hematopoietic stem cell transplantation (auto-HSCT)
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic CAR-T cell therapy | Experimental | RN1201 cells injection will be infused via intravenously Receives: Biological: 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 dose-limiting toxicities (DLTs)
TEAEs and DLTs will be graded according to CTCAE v5.0 and ASTCT consensus criteria
Measured: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 months post-treatment.
Secondary outcomes (7)
Objective Response Rate (ORR)
Identify the number of patients with complete response (CR), Identify the number of patients with partial response (PR), and Calculate ORR=(CR+PR)/total patients
Measured: Week 4, Month 3, Month 6 and Month 12
Disease control rate (DCR)
Identify the number of patients with complete response (CR), partial response (PR), stable disease (SD) and calculate DCR=(CR+PR+SD)/total patients
Measured: Week 4, Month 3, Month 6 and Month 12
Progression-free survival (PFS)
PFS defned as the time from the date of RN1201 infusion to the frst assessment of confrmed disease progression or death
Measured: Week 4, Month 3, Month 6 and Month 12
Overall survival (OS)
OS defned as the time from the date of RN1201 infusion to death
Measured: Week 4, Month 3, Month 6 and Month 12
Cmax of RN1201
peak plasma concentration of CAR - T cells copy number and the positive rate
Measured: Up to 12 months
Tmax of RN1201
Time to maximum concentration of RN1201
Measured: Up to 12 months
Cytokines in the peripheral blood after RN1201 infusion
Serum concentrations of interleukin (IL)-2, IL-6, IL-8, IL-10, interferon-gamma (IFN-γ), and TNF-α
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell Hematologic MalignanciesStudies 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
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lei Fan, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Lei Fan, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07113496
- Sponsor's protocol ID
- RN1201-Onc
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 13 Aug 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 13 Aug 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 CAR-T Cell (RN1201) for Relapsed/Refractory CD19+/BCMA+ Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07113496
- Acronym / sponsor ID
- RN1201-Onc
- Conditions
- Relapsed or Refractory B-cell Hematologic Malignancies, B-cell Acute Lymphoblastic Leukemia (B-ALL), Multiple Myeloma (MM), Plasmablastic Lymphoma, Relapsed or Refractory CD19+/BCMA+ Hematologic Malignancies, Mature B-Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Aug 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.
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.
Detailed description
This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+/BCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status.Primary endpoints include treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), pharmacokinetics, and pharmacodynamics of UCAR-T. This study aims to provide initial evidence for the safety and anti-tumor activity of UCAR-T in CD19+/BCMA+ hematologic malignancies.
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 | Biological: Allogeneic CAR-TRN1201 cells injection will be infused via intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Voluntary participation with signed informed consent.
- Pathologically confirmed CD19-positive and/or B-cell maturation antigen (BCMA)-positive hematologic malignancy according to the WHO 2017 classification, including but not limited to multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), mature B-cell lymphomas, and plasmablastic lymphoma.
- Relapsed/refractory disease defined as failure to achieve complete remission after standard therapy, or relapse after an initial response during treatment or follow-up.
- Measurable disease required:
- Age ≥18 years; both sexes eligible.
Key exclusion criteria (10 listed)
- Known hypersensitivity, allergy, intolerance, or contraindication to CD19/BCMA-UCAR-T or any study drugs (fludarabine, cyclophosphamide, tocilizumab).
- Genetic syndromes: Fanconi, Kostmann, Shwachman, or any documented bone-marrow failure syndrome.
- Active or uncontrolled infection requiring IV antibiotics; evidence of severe active infection.
- NYHA Class III or IV heart failure (unless clearly secondary to the underlying malignancy).
- Central Nervous System (CNS) disorders unrelated to the primary hematologic malignancy.
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 |
|---|---|---|
| Allogeneic CAR-TPatients will receive lymphodepletion chemotherapy followed by a single intravenous infusion of Allogeneic CAR-T cells. In select cases, CAR-T infusion may be administered post-autologous hematopoietic stem cell transplantation (auto-HSCT) | Biological | Allogeneic CAR-T cell therapy |
Primary outcome
The incidence and severity of treatment-emergent adverse events (TEAEs) and dose-limiting toxicities (DLTs)
Time frame: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 months post-treatment.
TEAEs and DLTs will be graded according to CTCAE v5.0 and ASTCT consensus criteria
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Week 4, Month 3, Month 6 and Month 12
Disease control rate (DCR)
Time frame: Week 4, Month 3, Month 6 and Month 12
Progression-free survival (PFS)
Time frame: Week 4, Month 3, Month 6 and Month 12
Overall survival (OS)
Time frame: Week 4, Month 3, Month 6 and Month 12
Cmax of RN1201
Time frame: Up to 12 months
Tmax of RN1201
Time frame: Up to 12 months
Cytokines in the peripheral blood after RN1201 infusion
Time frame: Up to 12 months
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 13 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Lei Fan principal investigator
The First Affiliated Hospital with Nanjing Medical University
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 Allogeneic CAR-T in people with Relapsed or Refractory B-cell Hematologic Malignancies and B-cell Acute Lymphoblastic Leukemia (B-ALL), run by The First Affiliated Hospital with Nanjing Medical 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 14 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Aug 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?
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 Lei Fan (086+025-68306124, fanlei@jsph.org.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 dose-limiting toxicities (DLTs) (time frame: DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 12 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 13 Aug 2025.