CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia

NCT ID: NCT03854994

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2022-08-01

Brief Summary

The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and B-cell acute lymphoblastic leukemia （B-ALL）.

Detailed Description

The investigators designed an KD-019 Chimeric Antigen Receptor(CAR) with FMC63 single-chain antibody fragment (Scfv). This CAR has a CD8 hinge and transmembrane domains and a 4-1BB costimulatory domain; T cells expressing this CAR release relatively low levels of cytokines. Subjects with relapsed/refractory CD19-positive B-cell Lymphoma and B-ALL can participate if all eligibility criteria are met. Subjects receive chemotherapy prior to the infusion of KD-019 CAR-T cells. After the infusion, subjects will accept follow-up for side effects and effect of KD-019 CAR-T cells by the sponsor. Study procedures may be performed while hospitalized.

Conditions

B Cell Lymphoma; B-cell Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-CD19 CAR-T Cells Injection

Dosage form：injection Dosage:1-5x10\^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes Frequency: total one time

Group Type: EXPERIMENTAL

Anti-CD19 CAR-T Cells Injection

Intervention Type: BIOLOGICAL

Autologous genetically modified anti-CD19 CAR transduced T cells

Interventions

Anti-CD19 CAR-T Cells Injection

Autologous genetically modified anti-CD19 CAR transduced T cells

Intervention Type: BIOLOGICAL

Other Intervention Names

KD-019 CAR-T cells Injection

Eligibility Criteria

Inclusion Criteria

1. Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;

2. 18 Years and older, Male and female;

3. Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program;

B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:

1. B-cell acute lymphoblastic leukemia;

2. Indolent B-cell lymphomas;

3. Aggressive B-cell lymphoma; 4、 Subjects:

(1) Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.

5、 Have measurable or evaluable tumor foci; 6、 Liver, kidney and cardiopulmonary functions meet the following requirements:

1. Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) <3 ×upper limit of normal (ULN);

2. Total bilirubin ≤34.2μmol/L;

3. Serum creatinine<220μmol/L;

4. Baseline oxygen saturation≥95%;

5. Left ventricular ejection fraction（LVEF）≥40%. 7、 Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss); 8、Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2，Expected survival≥3 months;

Exclusion Criteria

1. Pregnant (urine/blood pregnancy test positive) or lactating women;

2. Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;

3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment;

4. Active or uncontrollable infection within four weeks prior to enrollment;

5. Patients with active hepatitis B/C;

6. HIV-infected patients;

7. Severe autoimmune or immunodeficiency disorders;

8. Patients are allergic to macromolecule drugs such as antigens or cytokines;

9. Subjects participated in other clinical trials within 6 weeks before enrollment;

10. Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);

11. Mental illness;

12. Drug abuse/addiction;

13. The investigators consider other conditions unsuitable for enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KAEDI

OTHER

Sponsor Role: collaborator

Yan'an Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peixian Zhang

Role: STUDY_DIRECTOR

Kunming Yan'an Hospital

Locations

Kunming Yan'an Hospital, Oncology Department

Kunming, Yunnan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Peixian Zhang

Role: CONTACT

px29@163.com

86-0871-63211268

Facility Contacts

Lan Shi

Role: primary

shi_lanlan@yahoo.com

86-18988158897

Jiabao Song

Role: backup

jiabaosong668@gmail.com

86-15663656065

Other Identifiers

201707202

Identifier Type: -

Identifier Source: org_study_id