Trials Sponsors Conditions Drugs Pricing

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 LentiviralBiological

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Nanjing Legend Biotech Co.
Industrycollaborator
The First Affiliated Hospital with Nanjing Medical University
Otherlead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, China

Lei Fan, DoctorCONTACT13813976136 fanlei3014@126.com

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological 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

November 1, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

December 30, 2029

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (7)

Study Arms (1)

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

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations