Brief Summary

This is a single arm, open-label study to evaluate the safety and efficacy of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started May 2019

Typical duration for phase_1

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.6 years study duration

Study Start

First participant enrolled

May 27, 2019

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed

Last Updated

August 7, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

July 1, 2019

Last Update Submit

August 5, 2019

Conditions

Acute Lymphoblastic Leukemia B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

Number of participants with adverse events
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
5 years

Secondary Outcomes (7)

One-month remission rate
1 month
Overall survival
5 years
Event-free survival
5 years
Relapse-free survival
5 years
Rate of anti-CD19 CAR-T cells in bone marrow cells and peripheral blood cells
5 years
+2 more secondary outcomes

Study Arms (1)

Second generation humanized CAR-T cells

EXPERIMENTAL

Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.

Genetic: Second generation humanized CAR-T cells

Interventions

Second generation humanized CAR-T cellsGENETIC

Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.

Second generation humanized CAR-T cells

Eligibility Criteria

Age14 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy; or relapsed after auto-HSCT/allo-HSCT; or patients voluntarily choose CD19 CAR-T cells as a first treatment;
B cell hematological malignancies include the following three categories:
A. B-cell acute lymphocytic leukemia (B-ALL);
B. Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
C. Aggressive B-cell lymphoma (DLBCL, BL, MCL);
Aged from 14 to 70 years old;
Expected survival time \> 6 months;
Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.

You may not qualify if:

With a history of epilepsy or other central nervous system diseases;
Having graft-versus-host reaction, requires the use of immunosuppressants;
The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
Not curable active infection;
Patients with active hepatitis B or hepatitis C virus infection;
Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
Using product of gene therapy before;
Creatinine\> 2.5 mg / dl (221.0 umol/L); ALT / AST\> 3 X the normal amount; Bilirubin\> 2.0 mg / dl (34.2 umol/L);
Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
Patients with HIV-infection;
Any situation that may increase the risk of patients or interfere with test results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Wuhan Sian Medical Technology Co., Ltdlead
Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
Jingzhou Central Hospitalcollaborator
Xiangyang Central Hospitalcollaborator
People Hospital Of Yichangcollaborator

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (2)

Du M, Mayombo RTM, Liu J, Zhang Y, Liao D, Hu Y, Mei H. The impact of obesity and its related underlying diseases on cytokine release syndrome and the efficacy of CAR-T therapy in treating B-cell malignancies. Ann Hematol. 2025 Mar;104(3):1887-1895. doi: 10.1007/s00277-025-06338-6. Epub 2025 Apr 8.
PMID: 40195173DERIVED
Zhang Y, Zhou F, Wu Z, Li Y, Li C, Du M, Luo W, Kou H, Lu C, Mei H. Timing of Tocilizumab Administration Under the Guidance of IL-6 in CAR-T Therapy for R/R Acute Lymphoblastic Leukemia. Front Immunol. 2022 Jun 21;13:914959. doi: 10.3389/fimmu.2022.914959. eCollection 2022.
PMID: 35799791DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-HodgkinLymphoma

Study Officials

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

Central Study Contacts

Yu Hu, M.D., Ph.D

CONTACT

86-13986183871 dr_huyu@126.com

Heng Mei, M.D., Ph.D

CONTACT

86-13886160811 hmei@hust.edu.cn

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

May 27, 2019

Primary Completion

July 1, 2022

Study Completion

December 31, 2022

Last Updated

August 7, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing: Will not share

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Second generation humanized CAR-T cells

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations