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

ConditionHematological Malignancies
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe 923rd Hospital of Joint Logistics Support Force of People's Liberation Army

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

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

    Drug

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

Treatment groups

47 Participants
are divided into 2 treatment groups
Group A: in vivo CAR-T drug, Escalation dosesExperimental treatment 1 intervention
Group B: in vivo CAR-T drug, Extended dosesExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: