CClinicalTrials.gg
Not yet recruitingNCT07362602Updated Jan 23, 2026

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

An Early Phase 1 interventional study of In vivo CAR-T drug targeting CD20 based on mRNA-LNP in Hematological Malignancies, sponsored by The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-23.

Sponsored by The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
47
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hematological Malignancies
03

In context

Hematologic Neoplasms

1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.

This study's planned enrollment of 47 is close to the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.

Browse Hematologic Neoplasms studies →

Lead sponsor

The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    in vivo CAR-T drug, Escalation doses

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

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

  • Experimental
    in vivo CAR-T drug, Extended doses

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

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

Interventions

  • DrugIn vivo CAR-T drug targeting CD20 based on mRNA-LNP

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

06

What researchers measure

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Time frame: Within 28 days after the initial treatment

  2. The incidence of adverse effects

    Time frame: Through study completion, an average of 2 years

  3. Maximum tolerated dose (MTD) or optimal biological dose (OBD)

    Time frame: Through study completion, an average of 2 years

Secondary outcomes

  1. 0bjective response rate (ORR)

    Time frame: Through study completion, an average of 2 years

  2. Disease control rate (DCR)

    Time frame: Through study completion, an average of 2 years

  3. 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

  4. 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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07362602
Lead sponsor
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
Responsible party
Xiaolin Yin (Professor, The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army) — Principal investigator
First posted
Jan 23, 2026
Start date
Jan 26, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jan 23, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion