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

NCT07763938 | Not Yet Recruiting Phase 1

• 1 other identifier: LB2501-0003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Phase Ib 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

Conditions

Relapsed/Refractory B-cell Malignancies

Outcome Measures

Primary Outcomes (2)

• Incidence, severity, and category of treatment-emergent adverse events (TEAEs)

  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)

• Objective response rate (ORR) and complete response (CR) rate (or the proportion of subjects achieving very good partial response [VGPR] or better) assessed per protocol-specified efficacy evaluation criteria stratified by disease type

  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)

Secondary Outcomes (7)

• Further evaluation of efficacy endpoints stratified by disease subtype: Time to Response (TTR)

  Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)

• Further evaluation of efficacy endpoints stratified by disease subtype: Duration of Response (DOR)

  Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)

• Further evaluation of efficacy endpoints stratified by disease subtype: Progression Free Survival (PFS)

  Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)

• Further evaluation of efficacy endpoints stratified by disease subtype: Overall Survival (OS)

  Through study completion, an average 2 years after CD19/CD20 Dual-Target in vivo CAR-T Lentiviral infusion (Day 1)

• 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)

Study Arms (1)

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

EXPERIMENTAL

Each subject will receive a single dose of CD19/CD20 Dual-Target in vivo CAR-T Lentiviral product infusion.

Biological: CD19/CD20 Dual-Target in vivo CAR-T Lentiviral

Interventions

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

Prior to infusion of theCD19/CD20 Dual-Target in vivo CAR-T Lentiviral product, subjects may receive bridging therapy if needed.

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

Eligibility Criteria

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

You may qualify if:

• 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.
• Age greater than or equal to 18.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• At least one measurable tumor lesion.
• Eligible subjects shall meet the criteria and qualification requirements of any one of the expansion cohorts as follows:
• Cohort 1: Relapsed or refractory large B-cell lymphoma patients who have received at least one line of systemic therapy and have not undergone CAR-T therapy;
• Cohort 2: High-risk large B-cell lymphoma patients in the first-line setting (who have completed 2 cycles of standard first-line systemic immunochemotherapy);
• Cohort 3: Relapsed or refractory mantle cell lymphoma patients treated with at least two lines of systemic therapy;
• Cohort 4: Exploratory cohort including relapsed or refractory indolent lymphoma and other B-cell malignancies.
• Life expectancy≥ 3 months
• Clinical laboratory values meet screening visit criteria
• Adequate organ function;

You may not qualify if:

• Subject eligible for this study must not meet any of the following criteria:
• Prior antitumor therapy with insufficient washout period ;
• Prior treatment with lentiviral vector-based gene therapies;
• 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).
• 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).
• Lactating women;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Nanjing Legend Biotech Co.: collaborator

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, China

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lei Fan

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Fan

CONTACT

13813976136; fanlei3014@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of lymphoma center

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2032
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)