The CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/Refractory B-cell Malignancies

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the Treatment of Relapsed/Refractory B-cell Malignancies.

Study Overview

• Status: Recruiting
• Conditions: Relapsed/Refractory B-cell Malignancies
• Intervention / Treatment: Biological: CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product

Detailed Description

This is an open-label, dose-escalation/dose extension study to assess the safety, tolerability, and efficacy of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product in the patient ≥ 18 years of age with relapsed or refractory B-cell Malignancies. Subjects who meet the eligibility criteria will receive a single dose of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product. The study will include the following sequential phases: screening, bridging therapy (if needed), treatment, and follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: FAN Lei; Phone Number: +86 13813976136; Email: fanlei3014@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • The First Affiliated Hospital of USTC west district
      • Principal Investigator: Kaiyang DING
      • Contact: Kaiyang DING; Phone Number: +86 13966672170; Email: dingkaiy@126.com
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102206
      • Recruiting
      • Beijing Gobroad Boren Hospita
      • Principal Investigator: Yajing ZHANG
      • Contact: Yajing ZHANG; Phone Number: +86 18601333856; Email: 23975701@qq.com
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Recruiting
      • The Fourth Hospital of Hebei Medical University
      • Principal Investigator: Haisheng LIU
      • Contact: Haisheng LIU; Phone Number: +86 13933078299; Email: liuhs78299@163.com
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Not yet recruiting
      • The First Affiliated Hospital of Zhengzhou University
      • Principal Investigator: Yi Zhang
      • Contact: Yi Zhang; Phone Number: +86 15138928971; Email: yizhang001@163.com
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Principal Investigator: Heng Mei
      • Contact: Heng MEI; Phone Number: +86 13886160811; Email: mayheng@126.com
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • The First Affiliated Hospital with Nanjing Medical University
      • Principal Investigator: Lei Fan
      • Contact: Lei FAN; Phone Number: +186 13813976136; Email: fanlei3014@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects voluntarily participate in clinical studies; Fully informed of this study and signed informed consent; Informed consent form must be obtained prior to initiation of any study-related tests or procedures that are not part of the standard treatment for the subject's disease; Good compliance and cooperation with follow-up.
2. Age greater than or equal to 18.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. At least one evaluable tumor lesion.
5. Relapsed and/or refractory NHL , and relapsed and/or refractory CLL with treatment indications
6. Life expectancy≥ 3 months
7. Clinical laboratory values meet screening visit criteria
8. Adequate organ function;

Exclusion Criteria:

Subject eligible for this study must not meet any of the following criteria:

1. Prior antitumor therapy with insufficient washout period ;
2. Prior treatment with lentiviral vector-based gene therapies;
3. Patients who are positive for hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), and human immunodeficiency virus antibody (HIV-Ab).
4. Known life-threatening allergic reaction, hypersensitivity reaction, or intolerance to study drug excipients and related excipients, including but not limited to DMSO; or those with a history of severe allergic reactions in the past (such as hypersensitivity reactions, or those with severe immune-related reactions such as the need for glucocorticoids to prevent anaphylaxis as assessed by the investigator).
5. Lactating women;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD19/CD20 Dual-Target in vivo CAR-T Lentiviral; Each subject will be given a single-dose CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product infusion at each dose level.	Biological: CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product; Prior to infusion of theCD19/CD20 Dual-Target in vivo CAR-T Lentiviral product, subjects will receive bridging therapy if needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events)	An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.	Through study completion, an average of 2 years afterCD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Pharmacokinetics in peripheral blood	CAR positive T cells and CAR transgene percentage of in peripheral blood after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.	Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Pharmacokinetics in bone marrow	CAR positive T cells and CAR transgene percentage of in bone marrow after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.	Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
The recommended Phase II dose (RP2D) for this cell therapy	RP2D established through 3+3 design and the DLTs occurring following CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion	30 days after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via CD19/CD20 Dual-Target in vivo CAR-T Lentiviral cell infusion	Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Progression-free survival (PFS)	Progression Free Survival (PFS) is defined as the time from the date of first infusion of the CD19/CD20 Dual-Target in vivo CAR-T Lentiviral to the first documented disease progression or death, whichever occurs first	Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Overall Survival (OS)	Overall Survival (OS) is defined as the time from the date of first infusion of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral to death of the subject	Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Time to Response (TTR)	Time to Response (TTR) is defined as the time from the date of first infusion of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral to the date of the first response evaluation of the subject who has met all criteria for CR or PR	Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Duration of Response (DoR)	Duration of Remission (DoR) is defined as the time from the first documentation of remission (CR or PR) to the first documented relapse evidence of the responders	Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
Immunogenicity assessment of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion	The incidence of Anti- CD19/CD20 Dual-Target in vivo CAR-T Lentiviral antibody in patients who received CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion	Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Nanjing Legend Biotech Co.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: May 14, 2025
• First Submitted That Met QC Criteria: May 23, 2025
• First Posted (Actual): June 3, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: LB2409-0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No