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

NCT07002112 · tracked via the Priya Life Science China tracker

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Phase

Phase 1

Started

2025-05-23

Last updated

2026-05-14

Condition(s) studied

Relapsed/Refractory B-cell Malignancies

Investigational drug(s) / intervention(s)

CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product

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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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;

Primary outcome measure(s)

Incidence, severity and type of TEAEs (Treatment-emergent Adverse Events) — Through study completion, an average of 2 years afterCD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
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.
Pharmacokinetics in peripheral blood — Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in peripheral blood after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.
Pharmacokinetics in bone marrow — Through study completion, an average of 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)
CAR positive T cells and CAR transgene percentage of in bone marrow after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion.
The recommended Phase II dose (RP2D) for this cell therapy — 30 days after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion
RP2D established through 3+3 design and the DLTs occurring following CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion

Trial sites (6)

Facility	City	Region	Status
The First Affiliated Hospital of USTC west district	Hefei	Anhui	Recruiting
Beijing Gobroad Boren Hospita	Beijing	Beijing Municipality	Recruiting
The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei	Recruiting
The First Affiliated Hospital of ZHENGZHOU University	Zhengzhou	Henan	Not Yet Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei	Recruiting
The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07002112 on ClinicalTrials.gov ↗ ← All trials in China