Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies
A Phase 1/2 Study Evaluating the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-Modified T Cell (CAR-T) Therapy Bridging to Hematological Stem Cell Transplantation (HSCT) for Relapsed/Refractory CD19+ B-Cell Malignancies
1 other identifier
interventional
50
1 country
1
Brief Summary
This is the second stage of the previous anti-CD19 CAR-T therapy (NCT02965092). The study aims to evaluate the safety and efficacy of consolidative allo-HSCT following CAR-T therapy in patients with relapsed or refractory B cell Malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2016
Longer than P75 for phase_1
1 active site
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
Study Start
First participant enrolled
April 15, 2016
CompletedFirst Submitted
Initial submission to the registry
December 1, 2017
CompletedFirst Posted
Study publicly available on registry
December 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedMay 10, 2019
May 1, 2019
4.7 years
December 1, 2017
May 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
To evaluate the safety of anti-CD19 CAR-T therapy bridging to allo-HSCT. 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 (3)
Overall survival
5 years
Event-free survival
5 years
Relapse-free survival
5 years
Study Arms (1)
Consolidative allo-HSCT following CAR-T therapy
EXPERIMENTALPatients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.
Interventions
Patients receive allogeneic hematological stem cell transplantation after they achieve MRD- CR through CAR-T therapy.
Eligibility Criteria
You may qualify if:
- The patient is pathologically and histologically confirmed as CD19 + B cell malignancies, and has achieved MRD-negative CR through CAR-T therapy (NCT02965092);
- B cell hematological malignancies include the following three categories:
- B-cell acute lymphocytic leukemia (B-ALL);
- Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
- Aggressive B-cell lymphoma (DLBCL, BL, MCL);
- \< 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 themselves, or legally authorized representative.
You may not qualify if:
- With a history of epilepsy or other central nervous system diseases;
- Previous allogeneic hematopoietic stem cell transplantation;
- 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);
- 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, China
Related Publications (1)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
YU HU, M.D., Ph.D
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
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
December 1, 2017
First Posted
December 8, 2017
Study Start
April 15, 2016
Primary Completion
January 1, 2021
Study Completion
June 1, 2021
Last Updated
May 10, 2019
Record last verified: 2019-05