B-cell Lymphoma RefractoryPhase 2NCT07321301
Polymer-lipid Particle-delivered CAR1920 mRNA CAR-T Therapy for Relapsed/Refractory B-cell Lymphoma/Leukemia
A Phase 2 study testing Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy in people with B-cell Lymphoma Refractory, run by Daihong Liu at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of the CAR-T cell immunotherapy utilizing polymer-lipid nanoparticles for delivering CD19/CD20 dual-targeting InViVoCAR1920 mRNA, for the first-line consolidation therapy of relapsed/refractory B-cell lymphoma/leukemia. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- B-cell Lymphoma Refractory
- What is being tested?
- Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Aug 2027
- Phase
- Phase 2
- 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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has voluntarily given informed consent, signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, imaging examinations, and other necessary trial procedures as required in the protocol;
- Patients with relapsed/refractory (R/R) B-cell lymphoma/leukemia confirmed by histopathology, cytogenetics, molecular biology, clinical judgment, medical history, and other assessment methods in accordance with the WHO 2016 classification criteria, who have experienced disease progression under standard treatment regimens, are intolerant to standard treatment regimens, or lack effective standard treatment options;
- Must meet the following criteria for R/R B-cell malignant tumors:
- B-cell tumors include 3 categories:
- B-cell acute lymphoblastic leukemia (B-ALL);
- ② Indolent B-cell lymphomas, including chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), hairy cell leukemia (HCL), etc.;
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- ③ Aggressive B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), mantle cell lymphoma (MCL); (2) R/R B-ALL (meeting any 1 of the 4 criteria below):
- Relapse within 6 months after the first complete response (CR);
- Primary refractory patients who failed to achieve CR after 2 cycles of standard chemotherapy;
- Failure to achieve CR or relapse after first-line or multi-line salvage chemotherapy; ④ Relapse after hematopoietic stem cell transplantation (HSCT); (3) R/R B-cell lymphoma (meeting any 1 of the first 4 criteria below plus criterion 5):
- Tumor reduction < 50% or disease progression after 4 courses of standardized chemotherapy per standard regimens;
- Relapse within 6 months after achieving CR with standard chemotherapy;
- ≥ 2 relapses after CR;
- Relapse after HSCT; ⑤ Adequate prior treatment received, including at least anti-CD20 monoclonal antibody and anthracycline-containing combination chemotherapy regimens; 4. Aged 18-85 years (inclusive), male or female; 5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 6. Expected survival > 14 days from the date of signing the informed consent form; 7. Hemoglobin (HGB) ≥ 60 g/L (transfusion allowed); 8. Absolute neutrophil count (ANC) ≥ 1,000/μl and platelet count ≥ 45,000/μl in peripheral blood (transfusion allowed); 9. Hepatic, renal, cardiac, and pulmonary functions meeting the following requirements:
- Total Bilirubin (TBIL) ≤ 1.5 × Upper Limits of Normal (ULN), excluding subjects with Gilbert's syndrome;
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN;
- Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance Rate (CCr) ≥ 60 mL/min (CCr estimated by the Cockcroft-Gault formula);
- Left Ventricular Ejection Fraction (LVEF) ≥ 50%; echocardiogram (ECHO) confirms no clinically significant severe pericardial effusion or severe arrhythmia;
- Baseline transcutaneous oxygen saturation > 90% under room air;
- No clinically significant severe pleural effusion; 10. Subjects with pregnancy plans must agree to use contraceptive measures from before study enrollment until 6 months after the end of the study;
Who cannot join
- Previous receipt of any form of chimeric antigen receptor (CAR) cell therapy or other genetically modified T-cell therapies;
- History of severe immediate-type hypersensitivity reactions to commonly used drugs such as aminoglycoside antibiotics;
- Known history of Human Immunodeficiency Virus (HIV) infection, active Hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined as meeting all three of the following criteria: a. HBV DNA quantitation ≥ 2000 IU/ml; b. ALT ≥ 2 × Upper Limits of Normal (ULN); c. Exclusion of hepatitis caused by other factors such as the disease itself or medications. If a patient was diagnosed with active HBV infection initially and converted to inactive HBV infection after anti-HBV treatment, they may be included in this study with adequate ongoing anti-HBV treatment);
- Hepatic or renal impairment unrelated to hematologic malignancies (e.g., lymphoma): ALT > 3 × ULN, AST > 3 × ULN, TBIL > 2 × ULN, or serum creatinine clearance < 30 mL/min;
- History of myocardial infarction, cardiac angioplasty, coronary artery stenting, unstable angina pectoris, active arrhythmia, or other clinically significant cardiovascular diseases within 12 months prior to enrollment;
- Other severe medical conditions that may affect the study (e.g., poorly controlled diabetes mellitus, gastric ulcer, other severe cardiorespiratory diseases, concurrent severe autoimmune diseases or congenital immunodeficiencies, uncontrolled severe infections, etc.), as well as other diseases with a high risk of condition deterioration; patients who received allogeneic hematopoietic stem cell transplantation (allo-HSCT) and still have acute graft-versus-host disease (GVHD) 1 month after discontinuing immunosuppressants. The decision is at the investigator's discretion;
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- History of severe immediate-type hypersensitivity reactions to any specific drugs required in this study; or history of severe hypersensitivity to biological products (including antibiotics);
- Female subjects who are pregnant or lactating (due to potential risks of treatment to the fetus or infant);
- Subjects judged by the investigator to be unable to complete all scheduled visits, investigations, or diagnostic and therapeutic procedures required by the study protocol (including medium- and long-term follow-up visits), those with poor willingness to participate, those who are unwilling to join or fully cooperate with the study arrangements, or those with insufficient compliance of the subject and their family members. The decision is at the investigator's discretion;
- Concurrent progressive malignant tumors of other types; or a history of other malignant tumors, except for non-melanoma skin cancers and carcinoma in situ (e.g., of the cervix, bladder, or breast). Subjects with a history of other malignant tumors are ineligible unless they have been disease-free and not received any form of anti-tumor treatment for at least 3 consecutive years;
- History of live vaccine vaccination within 6 weeks prior to the start of the conditioning regimen;
- Receipt of major surgical procedures (excluding lymph node biopsy) within the past 14 days, or anticipated need for major surgery during the treatment period;
- Other severe physical or mental illnesses or laboratory abnormalities that may increase the risk of study participation or interfere with study results, as well as patients deemed unsuitable for participation by the investigator.
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
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: An Exploratory Clinical Study of CAR-T Cell Immunotherapy Using Polymer-lipid Particles to Deliver CAR1920 mRNA Targeting CD19/CD20 for Thetreatment of Relapsed/Refractory B-cell Lymphoma/Leukemia
The purpose of this study is to determine the efficacy and safety of the CAR-T cell immunotherapy utilizing polymer-lipid nanoparticles for delivering CD19/CD20 dual-targeting InViVoCAR1920 mRNA, for the first-line consolidation therapy of relapsed/refractory B-cell lymphoma/leukemia.
Read the detailed description
Since 2010, Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T Cell Immunotherapy) has demonstrated excellent targeting, cytotoxicity, and durability in tumor treatment, achieving well-recognized clinical efficacy in hematological malignancies. CAR-T Cell Immunotherapy refers to a technique that uses genetic modification to introduce genetic material encoding a specific antigen-recognition domain and T-cell activation signals into T cells. These engineered T cells are activated by direct binding to specific antigens on the surface of tumor cells, directly killing tumor cells through the release of perforin, granzyme B, etc. Simultaneously, they recruit endogenous immune cells in the human body to eliminate tumor cells by secreting cytokines, thereby achieving tumor treatment. Furthermore, they can form memory T cells to establish a specific and long-term anti-tumor mechanism.CD19 and CD20 are specific markers of B-cell malignancies, widely expressed in various B-cell malignant tumors. However, single-antigen targeting is prone to inducing antigen escape, as tumor cells often evade recognition and attack by CAR-T cells by losing or downregulating the expression of a single target antigen. Nevertheless, it is relatively difficult for tumor cells to alter the expression of two antigens simultaneously. For example, 70% of patients who relapse after CD19 CAR-T therapy exhibit loss of CD19 expression, a population that can be covered by CD20 CAR-T therapy. However, the efficacy of single-agent therapy is still limited by antigen heterogeneity. Dual-target CAR-T cells simultaneously target CD19 and CD20 antigens. Even if tumor cells escape via one antigen, they can still exert cytotoxic effects through recognition of the other antigen, thereby significantly reducing the risk of antigen escape, improving tumor clearance efficiency, and lowering the recurrence rate.Lipid Nanoparticles (LNPs) are composed of cationic lipids, helper lipids, cholesterol, and polyethylene glycol (PEG)-modified lipids. They can efficiently encapsulate mRNA to form stable nanoscale particle structures, effectively protecting mRNA from degradation by nucleases in the body. Through interaction with the cell surface, LNPs can precisely deliver mRNA into T cells, enabling transient expression of CAR proteins and in situ generation of CAR-T cells. This technology eliminates the need for ex vivo cell manipulation, significantly shortening the treatment cycle and allowing patients to receive therapy more quickly. Meanwhile, it avoids the potential T-cell exhaustion that may occur during ex vivo T-cell expansion, improving the yield of effective therapeutic products.
- Conditions
- B-cell Lymphoma Refractory
- Being tested
- Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy
- Keywords
- consolidation therapy, B-cell Lymphoma Refractory, CAR-T, Lipid Nanoparticles, RNA Transport, Patient Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell ImmunotherapyDrug
Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy in the Treatment of Patients with Relapsed/Refractory (R/R) B-Cell Lymphoma/Leukemia
| Study group | Role | What they receive |
|---|---|---|
| Patients with R/R B-Cell Lymphoma/Leukemia who accepted CD19/CD20 Dual-Targeting InViVoCAR-T | Experimental | Not described Receives: Drug: Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the safety and maximum tolerated dose of CAR-T cell immunotherapy mediated by polymer-lipid nanoparticles delivering CD19/CD20 dual-targeting InViVoCAR1920 mRNA in patients with relapsed/refractory B-cell lymphoma/leukemia
Measured: 3 months after treatment
Secondary outcomes (9)
30-day response rate
30-day response rate refers to the proportion of patients who achieve complete or partial response from the start of treatment.
Measured: 30 days
90-day response rate
90-day response rate refers to the proportion of patients who achieve complete or partial response 90 days after the start of treatment.
Measured: 90 days
overall survival (OS)
Overall survival (OS) refers to the time from the start of treatment to the death of the patient for any reason
Measured: 6 months after treatment
progression free survival (PFS)
Progression free survival (PFS) refers to the time from treatment to the first myeloma progression or death of the patient for any reason.
Measured: 6 months after treatment
time to progression (TTP)
Time to progression (TTP) refers to the time from treatment to the first myeloma progression.
Measured: 6 months after treatment
disease free survival (DFS)
Disease free survival (DFS) refers to the time from treatment to the first myeloma recurrence.
Measured: 3 months after treatment
duration of response (DOR)
Duration of Response (DOR) refers to the time from the first assessment of a myeloma as a complete or partial response to the first assessment of PD (Progressive Disease) or death from any cause.
Measured: 6 months after treatment
event free survival (EFS)
Event Free Survival (EFS) is a commonly used endpoint indicator in clinical trials to evaluate the survival time of patients without any adverse events during a specific time period. These adverse events include but are not limited to disease progression, death, treatment plan changes, and the occurrence of serious side effects.
Measured: 6 months after treatment
recurrence rate
The recurrence rate refers to the proportion of patients with lymphoma recurrence after treatment.
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Sep 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 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 Lymphoma RefractoryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daihong Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daihong Liu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321301
- Sponsor's protocol ID
- S2025-727
- Status last verified
- Oct 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of CAR-T Cell Immunotherapy Using Polymer-lipid Particles to Deliver CAR1920 mRNA Targeting CD19/CD20 for Thetreatment of Relapsed/Refractory B-cell Lymphoma/Leukemia
- ClinicalTrials.gov ID
- NCT07321301
- Acronym / sponsor ID
- S2025-727
- Conditions
- B-cell Lymphoma Refractory
- Keywords
- consolidation therapy, B-cell Lymphoma Refractory, CAR-T, Lipid Nanoparticles, RNA Transport, Patient Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Daihong LiuUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 7 Jan 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.
The purpose of this study is to determine the efficacy and safety of the CAR-T cell immunotherapy utilizing polymer-lipid nanoparticles for delivering CD19/CD20 dual-targeting InViVoCAR1920 mRNA, for the first-line consolidation therapy of relapsed/refractory B-cell lymphoma/leukemia.
Detailed description
Since 2010, Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T Cell Immunotherapy) has demonstrated excellent targeting, cytotoxicity, and durability in tumor treatment, achieving well-recognized clinical efficacy in hematological malignancies. CAR-T Cell Immunotherapy refers to a technique that uses genetic modification to introduce genetic material encoding a specific antigen-recognition domain and T-cell activation signals into T cells. These engineered T cells are activated by direct binding to specific antigens on the surface of tumor cells, directly killing tumor cells through the release of perforin, granzyme B, etc. Simultaneously, they recruit endogenous immune cells in the human body to eliminate tumor cells by secreting cytokines, thereby achieving tumor treatment. Furthermore, they can form memory T cells to establish a specific and long-term anti-tumor mechanism.CD19 and CD20 are specific markers of B-cell malignancies, widely expressed in various B-cell malignant tumors. However, single-antigen targeting is prone to inducing antigen escape, as tumor cells often evade recognition and attack by CAR-T cells by losing or downregulating the expression of a single target antigen. Nevertheless, it is relatively difficult for tumor cells to alter the expression of two antigens simultaneously. For example, 70% of patients who relapse after CD19 CAR-T therapy exhibit loss of CD19 expression, a population that can be covered by CD20 CAR-T therapy. However, the efficacy of single-agent therapy is still limited by antigen heterogeneity. Dual-target CAR-T cells simultaneously target CD19 and CD20 antigens. Even if tumor cells escape via one antigen, they can still exert cytotoxic effects through recognition of the other antigen, thereby significantly reducing the risk of antigen escape, improving tumor clearance efficiency, and lowering the recurrence rate.Lipid Nanoparticles (LNPs) are composed of cationic lipids, helper lipids, cholesterol, and polyethylene glycol (PEG)-modified lipids. They can efficiently encapsulate mRNA to form stable nanoscale particle structures, effectively protecting mRNA from degradation by nucleases in the body. Through interaction with the cell surface, LNPs can precisely deliver mRNA into T cells, enabling transient expression of CAR proteins and in situ generation of CAR-T cells. This technology eliminates the need for ex vivo cell manipulation, significantly shortening the treatment cycle and allowing patients to receive therapy more quickly. Meanwhile, it avoids the potential T-cell exhaustion that may occur during ex vivo T-cell expansion, improving the yield of effective therapeutic products.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with R/R B-Cell Lymphoma/Leukemia who accepted CD19/CD20 Dual-Targeting InViVoCAR-T | Experimental | Drug: Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Has voluntarily given informed consent, signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, imaging examinations, and other necessary trial procedures as required in the protocol;
- Patients with relapsed/refractory (R/R) B-cell lymphoma/leukemia confirmed by histopathology, cytogenetics, molecular biology, clinical judgment, medical history, and other assessment methods in accordance with the WHO 2016 classification criteria, who have experienced disease progression under standard treatment regimens, are intolerant to standard treatment regimens, or lack effective standard treatment options;
- Must meet the following criteria for R/R B-cell malignant tumors:
- B-cell tumors include 3 categories:
- B-cell acute lymphoblastic leukemia (B-ALL);
Key exclusion criteria (13 listed)
- Previous receipt of any form of chimeric antigen receptor (CAR) cell therapy or other genetically modified T-cell therapies;
- History of severe immediate-type hypersensitivity reactions to commonly used drugs such as aminoglycoside antibiotics;
- Known history of Human Immunodeficiency Virus (HIV) infection, active Hepatitis B Virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics (active HBV infection is defined as meeting all three of the following criteria: a. HBV DNA quantitation ≥ 2000 IU/ml; b. ALT ≥ 2 × Upper Limits of Normal (ULN); c. Exclusion of hepatitis caused by other factors such as the disease itself or medications. If a patient was diagnosed with active HBV infection initially and converted to inactive HBV infection after anti-HBV treatment, they may be included in this study with adequate ongoing anti-HBV treatment);
- Hepatic or renal impairment unrelated to hematologic malignancies (e.g., lymphoma): ALT > 3 × ULN, AST > 3 × ULN, TBIL > 2 × ULN, or serum creatinine clearance < 30 mL/min;
- History of myocardial infarction, cardiac angioplasty, coronary artery stenting, unstable angina pectoris, active arrhythmia, or other clinically significant cardiovascular diseases within 12 months prior to enrollment;
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 |
|---|---|---|
| Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell ImmunotherapyPolymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy in the Treatment of Patients with Relapsed/Refractory (R/R) B-Cell Lymphoma/Leukemia | Drug | Patients with R/R B-Cell Lymphoma/Leukemia who accepted CD19/CD20 Dual-Targeting InViVoCAR-T |
Primary outcome
the safety and maximum tolerated dose of CAR-T cell immunotherapy mediated by polymer-lipid nanoparticles delivering CD19/CD20 dual-targeting InViVoCAR1920 mRNA in patients with relapsed/refractory B-cell lymphoma/leukemia
Time frame: 3 months after treatment
9 secondary outcomes
30-day response rate
Time frame: 30 days
90-day response rate
Time frame: 90 days
overall survival (OS)
Time frame: 6 months after treatment
progression free survival (PFS)
Time frame: 6 months after treatment
time to progression (TTP)
Time frame: 6 months after treatment
disease free survival (DFS)
Time frame: 3 months after treatment
duration of response (DOR)
Time frame: 6 months after treatment
event free survival (EFS)
Time frame: 6 months after treatment
recurrence rate
Time frame: 3 months after treatment
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 7 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Polymer-Lipid Nanoparticle-Mediated Delivery of CD19/CD20 Dual-Targeting InViVoCAR1920 mRNA for CAR-T Cell Immunotherapy in people with B-cell Lymphoma Refractory, run by Daihong Liu 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 20 inclusion and 13 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 7 Jan 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Li-Ping Dou, Dr. (86-010-66937232, lipingruirui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the safety and maximum tolerated dose of CAR-T cell immunotherapy mediated by polymer-lipid nanoparticles delivering CD19/CD20 dual-targeting InViVoCAR1920 mRNA in patients with relapsed/refractory B-cell lymphoma/leukemia (time frame: 3 months after 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 7 Jan 2026.