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

NCT07362602 | Not Yet Recruiting Early Phase 1

• 1 other identifier: CD20-IIT-B cell malignancies
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  Within 28 days after the initial treatment

• The incidence of adverse effects

  Through study completion, an average of 2 years

• Maximum tolerated dose (MTD) or optimal biological dose (OBD)

  Through study completion, an average of 2 years

Secondary Outcomes (4)

• 0bjective response rate (ORR)

  Through study completion, an average of 2 years

• Disease control rate (DCR)

  Through study completion, an average of 2 years

• Duration of response (DoR)

  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)

  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

Study Arms (2)

in vivo CAR-T drug, Escalation doses

EXPERIMENTAL

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

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

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

Interventions

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

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

in vivo CAR-T drug, Escalation doses; in vivo CAR-T drug, Extended doses

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age range of 18-70 years old, gender not limited;
• \. Expected survival time exceeds 12 weeks;
• \. Diagnosed with blood system tumors such as CD20+B-cell lymphoma or lymphocytic leukemia and meeting the corresponding previous treatment requirements;
• \. There are assessable lesions (applicable only to lymphoma patients);
• \. 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;
• \. 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;
• \. Those who can understand this experiment and have signed the informed consent form.

You may not qualify if:

• \. Accompanied by other uncontrolled malignant tumors;
• \. Received chimeric antigen receptor therapy or other transgenic T cell therapy within 6 months;
• \. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;
• \. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;
• \. Participants with atrial or ventricular involvement;
• \. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;
• \. 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;
• \. 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;
• \. For those who have been using immunosuppressants for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;
• \. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;
• \. 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).
• \. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.

Sponsors & Collaborators

• The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 23, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01