Trials Sponsors Conditions Drugs Pricing

Conditions

Relapsed/Refractory B-cell Malignancies

Outcome Measures

Primary Outcomes (4)

Incidence of Adverse Events
All adverse events (AEs), including severe adverse events (SAEs) and clinically significant laboratory abnormalities, will be recorded and graded for severity using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Up to 28 days post-infusion
Incidence of Dose-Limiting Toxicities (DLTs)
Dose-limiting toxicities (DLTs) will be specifically identified, recorded, and monitored during the designated DLT observation period.
Up to 28 days post-infusion
Incidence and Severity of Cytokine Release Syndrome (CRS)
Cytokine release syndrome (CRS) events will be identified and graded for severity according to the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading.
Up to 28 days post-infusion
Incidence and Severity of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Immune effector cell-associated neurotoxicity syndrome (ICANS) will be assessed using the Immune Effector Cell-Associated Encephalopathy (ICE) score and subsequently graded for severity according to the ASTCT consensus grading.
Up to 28 days post-infusion

Secondary Outcomes (14)

Complete Response (CR) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
From ZZSW-01 infusion to the end of the treatment at 96 weeks
Partial Response (PR) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
From ZZSW-01 infusion to the end of the treatment at 96 weeks
Stable Disease (SD) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
From ZZSW-01 infusion to the end of the treatment at 96 weeks.
Progressive Disease (PD) Rate of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
From ZZSW-01 infusion to the end of the treatment at 96 weeks.
Objective response rate (ORR) of administering ZZSW-01 in the treatment of relapsed/refractory of B-cell malignancies.
From ZZSW-01 infusion to the end of the treatment at 96 weeks

Study Arms (1)

ZZSW-01

EXPERIMENTAL

ZZSW-01 is an extracellular vesicle that carries functional CD19 CAR mRNA, which can be administered intravenously to generate CAR-T cells in vivo.

Drug: ZZSW-01 injection

Interventions

ZZSW-01 injectionDrug

ZZSW-01 is an extracellular vesicle that carries functional CD19 CAR mRNA, which can be administered intravenously to generate CAR-T cells in vivo.

Also known as: CAR-EVs

ZZSW-01

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:

Age ≥18 years, no restriction on sex.
ECOG (Eastern Cooperative Oncology Group) performance status score of 0-2.

Sponsors & Collaborators

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Otherlead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, 430022, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Heng Mei, Ph.D&M.D
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
PRINCIPAL INVESTIGATOR

Central Study Contacts

Heng Mei, Ph.D&M.D

CONTACT

027-8572600 hmei@hust.edu.cn

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

September 3, 2025

First Posted

November 21, 2025

Study Start

October 28, 2025

Actual (reported)

Primary Completion

September 15, 2028

Estimated

Safety and Efficacy of ZZSW-01 in Relapsed/Refractory B-cell Malignancies

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (14)

Study Arms (1)

ZZSW-01

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

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (14)

Study Arms (1)

ZZSW-01

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