Anti-CD19 CAR-T Therapy Combine With HSCT to Treat MRD+ B-cell Malignancies

NCT03366324 | Unknown Phase 1

• 1 other identifier: CART-CD19-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

For micro residual disease (MRD) positive patients who have undergone at least 2 cycles chemotherapies for their CD19+ B-cell malignancies, there would be much more risks for them to receive hematological stem cell transplantation (HSCT) than MRD- patients. In order to reduce HSCT-related adverse events for these kind of patients, investigators plan to conduct CAR-T therapies on them first to make them achieve MRD- statuses, and then transfer them to HSCT.

Conditions

Acute Lymphoblastic Leukemia; B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of study related adverse events

  defined as \>= Grade 3（NCI CTCAE version 4.03） signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment

  200 days from enrollment

Secondary Outcomes (1)

• Number of participants with an MRD negative complete remission after CAR-T therapy and HSCT

  2 years from enrollment

Study Arms (1)

Combination of CAR-T therapy and HSCT

EXPERIMENTAL

After patients achieve MRD- remissions through Second generation CAR-T cells, they will subsequently receive hematological stem cell transplantations within 30 days.

Genetic: Second generation CAR-T cells; Procedure: Hematological stem cell transplantation

Interventions

Second generation CAR-T cells GENETIC

Patients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2.

Combination of CAR-T therapy and HSCT

Hematological stem cell transplantation PROCEDURE

Patients receive hematological stem cell transplantations within 3 months after they achieve MRD- remissions after CAR-T therapies.

Combination of CAR-T therapy and HSCT

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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 autologous hematopoietic stem cell transplantation (auto-HSCT); or patients voluntarily choose CD19 CAR-T cells as a first treatment;
• The patient is MRD+ (\<10%) after at least two cycles of chemotherapies.
• 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 allo-HSCT;
• With a history of epilepsy or other central nervous system diseases;
• 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.

Sponsors & Collaborators

• Wuhan Sian Medical Technology Co., Ltd: lead
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Jingzhou Central Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• The First People's Hospital of Yuhang District: collaborator

Study Sites (1)

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

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma

Study Officials

• YU HU, M.D., Ph.D

  Institute of Hematology, 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; mayheng@126.com

Study Design

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

Model Details: The only one group of patients will receive the combination of CAR-T therapy and HSCT.

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 8, 2017
• Study Start: May 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

CN (1)