B-cell MalignanciesEarly Phase 1NCT07349849
Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies
A Early Phase 1 study testing in vivo CAR-T drug based on LNP-mRNA in people with B-cell Malignancies, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed/refractory patients still faces significant… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B-cell Malignancies
- What is being tested?
- in vivo CAR-T drug based on LNP-mRNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2025to 31 Dec 2028
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age range of 18-70 years old, gender not limited;
- 2. Expected survival time exceeds 12 weeks;
- 3. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines
- 4. There are assessable lesions (applicable only to lymphoma patients);
- 5. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1;
- May involve other inclusion criteria
Who cannot join
- 1. Accompanied by other uncontrolled malignant tumors;
- 2. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy;
- 3. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;
- 4. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;
- 5. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.
- May involve other exclusion criteria
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
Department of Hematology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
Xi Zhang, MD phD, 13808310064 ext. +86, zhangxxi@sina.com
About this study
Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed/refractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors.
The advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. Lipid nanoparticles (LNP) are currently the most mature non viral delivery platform, capable of protecting mRNA from nuclease degradation, promoting intracellular uptake, and achieving efficient translation in vivo.
The core of LNP-mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins (such as anti-CD19 related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
- Conditions
- B-cell Malignancies
- Being tested
- in vivo CAR-T drug based on LNP-mRNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vivo CAR-T drug based on LNP-mRNADrug
in vivo CAR-T drug based on LNP-mRNA
| Study group | Role | What they receive |
|---|---|---|
| in vivo CAR-T drug based on LNP-mRNA | Experimental | Not described Receives: Drug: in vivo CAR-T drug based on LNP-mRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) and its incidence rate
Measured: Within 28 days after the initial treatment
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Measured: 3 months
Secondary outcomes (3)
Objective response rate (ORR)
Measured: 1 month
Disease control rate (DCR)
Measured: Through study completion, an average of 2 years
Progression free survival (PFS)
Measured: From date of initial treatment until the date of first comfired progression or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Dec 2025 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Zhang, MD, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349849
- Sponsor's protocol ID
- in vivo CAR-T of CD19
- Status last verified
- Jan 2026
- First submitted
- 19 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on mRNA Therapeutic Drug Targeting CD19 for the Treatment of Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT07349849
- Acronym / sponsor ID
- in vivo CAR-T of CD19
- Conditions
- B-cell Malignancies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 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.
Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed/refractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors.
The advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. Lipid nanoparticles (LNP) are currently the most mature non viral delivery platform, capable of protecting mRNA from nuclease degradation, promoting intracellular uptake, and achieving efficient translation in vivo.
The core of LNP-mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins (such as anti-CD19 related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| in vivo CAR-T drug based on LNP-mRNA | Experimental | Drug: in vivo CAR-T drug based on LNP-mRNA |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Age range of 18-70 years old, gender not limited;
- 2. Expected survival time exceeds 12 weeks;
- 3. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines
- 4. There are assessable lesions (applicable only to lymphoma patients);
- 5. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1;
Key exclusion criteria (6 listed)
- 1. Accompanied by other uncontrolled malignant tumors;
- 2. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy;
- 3. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;
- 4. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;
- 5. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.
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 |
|---|---|---|
| in vivo CAR-T drug based on LNP-mRNAin vivo CAR-T drug based on LNP-mRNA | Drug | in vivo CAR-T drug based on LNP-mRNA |
Primary outcome
Dose limiting toxicity (DLT) and its incidence rate
Time frame: Within 28 days after the initial treatment
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Time frame: 3 months
3 secondary outcomes
Objective response rate (ORR)
Time frame: 1 month
Disease control rate (DCR)
Time frame: Through study completion, an average of 2 years
Progression free survival (PFS)
Time frame: From date of initial treatment until the date of first comfired progression or date of death from any cause, whichever came first, assessed up to 24 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 20 Jan 2026.
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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 Early Phase 1 study testing in vivo CAR-T drug based on LNP-mRNA in people with B-cell Malignancies, run by Xinqiao Hospital of Chongqing 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 6 inclusion and 6 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 20 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) and its incidence rate (time frame: Within 28 days after the initial treatment). The study lists 2 primary outcomes in all. 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 20 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.