Anti-CD22 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy for Relapsed Refractory B-cell Malignancies

NCT04007978 | Unknown Phase 1

• 1 other identifier: WHUH-CART-CD22-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of anti-CD22 CAR-T cells in patients with relapsed or refractory B-cell Malignancies.

Conditions

B Cell Lymphoma; Acute Lymphoblastic Leukemia

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).

  3 years

Secondary Outcomes (7)

• One-month remission rate

  1 month

• Overall survival

  3 years

• Event-free survival

  3 years

• Relapse-free survival

  3 years

• Rate of anti-CD22 CAR-T cells in bone marrow cells and peripheral blood cells

  3 years

Study Arms (1)

Third generation CAR-T cells

EXPERIMENTAL

Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.

Genetic: Third generation CAR-T cells

Interventions

Third generation CAR-T cells GENETIC

Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.

Third generation CAR-T cells

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
• Male or female patients aged 14 to 70 years (including 14 and 70 years old).
• Pathological and histological examination confirmed CD22+ B-cell malignancies, and patients met the following criteria for refractory or relapsed B-cell malignancies.
• A.Refractory/relapsed B-cell lymphoblastic leukemia (Meeting one of the following)
• i. Recurrence within 6 months after first remission.
• ii. Primary refractory disease which cannnot achieve complete remission (CR) after 2 cycles of standardized chemotherapy regimen.
• iii. Failure to achieve CR or relapse after one line or multiple lines of salvage chemotherapy.
• iv. Not suitable for hematopoietic stem cell transplantation (HSCT), or abandon HSCT due to various restrictions, or relapse after HSCT.
• B.Refractory/relapsed B-cell lymphoma (Meeting 1 of the first 4 items plus item 5)
• i. Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
• ii. Achieved CR after standard chemotherapy, but relapsed within 6 months.
• iii. 2 or more relapses after CR.
• iv. Not suitable for HSCT, or abandon HSCT due to various restrictions, or relapse after HSCT.
• v. Subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines.
• B-cell malignancies include the following three types

You may not qualify if:

• Have a history of epilepsy or other central nervous system diseases.
• Women who are pregnant (urine/blood pregnancy test positive) or lactating.
• Male or female with a pregnancy plan in the next 1 year.
• Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment.
• Uncontrolled infectious disease within 4 weeks prior to enrollment.
• Active hepatitis B/C virus infection.
• HIV infected patients.
• Suffering from a serious autoimmune disease or immunodeficiency disease.
• The patient is allergic to macromolecular biopharmaceuticals such as antibodies or cytokines.
• The patient participated in other clinical trials within 6 weeks prior to enrollment.
• Systemic use of corticosteroids within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids).
• Suffering from mental diseases.
• Patient has drug abuse/addiction.
• According to the researcher's judgment, the patient has other unsuitable enrollment conditions.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• Wuhan Bio-Raid Biotechnology Co., Ltd.: collaborator

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

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: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 5, 2019
• Study Start: August 5, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)