Hematological MalignanciesEarly Phase 1NCT07362602

Exploratory Study on in Vivo CAR-T Therapy Targeting CD20 for the Treatment of Hematological Malignancies

A Early Phase 1 study testing In vivo CAR-T drug targeting CD20 based on mRNA-LNP in people with Hematological Malignancies, run by The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hematological Malignancies
What is being tested?: In vivo CAR-T drug targeting CD20 based on mRNA-LNP
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: No sites listed yet
Study dates: 26 Jan 2026to 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. Diagnosed with blood system tumors such as CD20+B-cell lymphoma or lymphocytic leukemia and meeting the corresponding previous treatment requirements;
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 point; Before screening (at baseline), corresponding requirements should be met;
7. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;
8. Those who can understand this experiment and have signed the informed consent form.

Who cannot join

1. Accompanied by other uncontrolled malignant tumors;
2. Received chimeric antigen receptor therapy or other transgenic T cell therapy within 6 months;
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. Participants with atrial or ventricular involvement;
6. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;

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7. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial;
8. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment;
9. For those who have been using immunosuppressants for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;
10. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;
11. Within 14 days prior to enrollment, there is an active or uncontrollable infection that requires systemic treatment (excluding simple urinary tract infections or upper respiratory tract infections).
12. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.

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. CD20 is a transmembrane protein highly expressed on the surface of B cells, almost penetrating the precursor, mature, and activated stages of B cells, but lacking in plasma cells, making it an ideal target for B cell malignancies.

In recent years, the breakthrough development of in vivo CAR-T therapy has overturned the traditional paradigm of in vitro CAR-T technology. The core principle is to directly deliver the gene encoding chimeric antigen receptor (CAR) to T cells in the patient's body through gene delivery vectors, without the need for in vitro isolation, modification, and amplification processes, and to complete the gene reprogramming of T cells in vivo. At present, the mainstream carrier technologies for CAR-T therapy in vivo are divided into two categories: lentiviral carriers and lipid nanoparticle (LNP) carriers. LNP carriers have significantly broken through the clinical bottlenecks of traditional CAR-T in terms of cost and accessibility, safety, and timeliness.

This experimental drug is a CD20 based messenger ribonucleic acid (mRNA) therapeutic drug, which is an injection formed by loading mRNA onto lipid nanoparticles (LNP). It has shown efficient B-cell clearance activity and good safety in non clinical settings, supporting further clinical exploration in B-cell hematological malignancies. It is expected to provide an innovative, safe, and accessible immunotherapy for B-cell hematological malignancies and bring better clinical benefits to more patients with B-cell hematological malignancies.

Conditions: Hematological Malignancies
Being tested: In vivo CAR-T drug targeting CD20 based on mRNA-LNP
Medical subject headings: Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

In vivo CAR-T drug targeting CD20 based on mRNA-LNPDrug
In vivo CAR-T drug targeting CD20 based on mRNA-LNP

Study groups in NCT07362602
Study group	Role	What they receive
in vivo CAR-T drug, Escalation doses	Experimental	In vivo CAR-T drug targeting CD20 based on mRNA-LNP Receives: Drug: In vivo CAR-T drug targeting CD20 based on mRNA-LNP
in vivo CAR-T drug, Extended doses	Experimental	In vivo CAR-T drug targeting CD20 based on mRNA-LNP Receives: Drug: In vivo CAR-T drug targeting CD20 based on mRNA-LNP

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose limiting toxicity (DLT)
Measured: Within 28 days after the initial treatment
The incidence of adverse effects
Measured: Through study completion, an average of 2 years
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Measured: Through study completion, an average of 2 years

Secondary outcomes (4)

0bjective response rate (ORR)
Measured: Through study completion, an average of 2 years
Disease control rate (DCR)
Measured: Through study completion, an average of 2 years
Duration of response (DoR)
Measured: From the date of the first PR/CR to the date of first comfired progression or date of death from any cause, whichever came first, assessed up to 24 months
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.

26 Jan 202631 Dec 2028

First posted23 Jan 2026
Study start26 Jan 2026 (estimated)
Primary completion31 Dec 2027 (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 Hematological 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: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 47 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07362602
Sponsor's protocol ID: CD20-IIT-B cell malignancies
Status last verified: Jan 2026
First submitted: 5 Jan 2026
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Myeloproliferative Neoplasms
RecruitingObservational study
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Hematological Malignancy, Hematopoetic Stem Cell Transplantation
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All Hematological Malignancies trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Study on in Vivo CAR-T Therapy Targeting CD20 for the Treatment of Hematological Malignancies
ClinicalTrials.gov ID: NCT07362602
Acronym / sponsor ID: CD20-IIT-B cell malignancies
Conditions: Hematological Malignancies
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 47 participants (estimated)
Lead sponsor: The 923rd Hospital of Joint Logistics Support Force of People's Liberation ArmyUniversity, hospital or other
Study start: 26 Jan 2026 (estimated)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 23 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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
in vivo CAR-T drug, Escalation doses	Experimental	Drug: In vivo CAR-T drug targeting CD20 based on mRNA-LNPIn vivo CAR-T drug targeting CD20 based on mRNA-LNP
in vivo CAR-T drug, Extended doses	Experimental	Drug: In vivo CAR-T drug targeting CD20 based on mRNA-LNPIn vivo CAR-T drug targeting CD20 based on mRNA-LNP

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

1. Age range of 18-70 years old, gender not limited;
2. Expected survival time exceeds 12 weeks;
3. Diagnosed with blood system tumors such as CD20+B-cell lymphoma or lymphocytic leukemia and meeting the corresponding previous treatment requirements;
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 point; Before screening (at baseline), corresponding requirements should be met;

Key exclusion criteria (12 listed)

1. Accompanied by other uncontrolled malignant tumors;
2. Received chimeric antigen receptor therapy or other transgenic T cell therapy within 6 months;
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. Participants with atrial or ventricular involvement;

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 targeting CD20 based on mRNA-LNPIn vivo CAR-T drug targeting CD20 based on mRNA-LNP	Drug	in vivo CAR-T drug, Escalation doses, in vivo CAR-T drug, Extended doses

Primary outcome

Dose limiting toxicity (DLT)
Time frame: Within 28 days after the initial treatment
The incidence of adverse effects
Time frame: Through study completion, an average of 2 years
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Time frame: Through study completion, an average of 2 years

4 secondary outcomes

0bjective response rate (ORR)
Time frame: Through study completion, an average of 2 years
Disease control rate (DCR)
Time frame: Through study completion, an average of 2 years
Duration of response (DoR)
Time frame: From the date of the first PR/CR to the date of first comfired progression or date of death from any cause, whichever came first, assessed up to 24 months
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 23 Jan 2026.

Related trials for Hematological Malignancies

RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
RecruitingPhase 1/2
Phase I/II Trial: Engineered Donor Graft (Orca Q) for Pediatric Hematopoietic Cell Transplant (HCT)
Acute Myeloid Leukemia, Acute Lymphoid Leukemia
RecruitingPhase 1
Study of INCA036978 in Participants With Myeloproliferative Neoplasms
Myeloproliferative Neoplasms
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Not yet recruitingPhase 2
Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers
Core Binding Factor Alpha Subunits, Hematologic Neoplasms

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

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 7 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: Within 28 days after the initial treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07362602.

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 23 Jan 2026.