Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas

NCT ID: NCT04196205

Last Updated: 2019-12-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-08-01

Brief Summary

This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.

Detailed Description

CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.

Conditions

Acute Lymphoblastic Leukemia ,Lymphomas

Study Design

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

Study Groups

Anti-CD19 CAR-T

Anti-CD19 CAR-T

Group Type: EXPERIMENTAL

Anti-CD19 CAR-T

Intervention Type: BIOLOGICAL

1 - 2×10\^6 Anti-CD19 CAR-T cells/kg body weigh

Interventions

Anti-CD19 CAR-T

1 - 2×10\^6 Anti-CD19 CAR-T cells/kg body weigh

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 18-70 years old ;

2. Estimated Survival time > 12 weeks;

3. Relapsed and refractory acute lymphoblastic leukemia and lymphoma were confirmed by physical examination, pathological examination, laboratory examination and imaging;

4. Chemotherapy failure or recurrent acute lymphoblastic leukemia and Lymphomas;

5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level;

6. Bilirubin<2.0mg/dl;

7. Karnofsky Performance Status>50% at the time of screening;

8. Adequate pulmonary, renal, hepatic, and cardiac function;

9. Fail in autologous or allogenic haemopoietic stem cell transplantation;

10. Not suitable for stem cell transplantation conditions or abandoned due to conditions;

11. Free of leukocytes removal contraindications;

12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent.

Exclusion Criteria

1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;

2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.);

3. The patient is an active hepatitis B or hepatitis C infection;

4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;

5. Abnormal vital signs;

6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation;

7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2;

8. General infection or local severe infection, or other infection that is not controlled;

9. Dysfunction in lung, heart, kidney and brain;

10. Severe autoimmune diseases;

11. Other symptoms that are not applicable for CAR-T.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

LiFei

M.D.,Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Nangchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fei Li, M.D., Ph.D.

Role: CONTACT

yx021021@sina.com

+86-139-7003-8386

Facility Contacts

Fei Li, M.D., Ph.D.

Role: primary

yx021021@sina.com

+86-139-7003-8386

Other Identifiers

2018027

Identifier Type: -

Identifier Source: org_study_id