Novel Autologou CAR-T Therapy for Relapsed/Refractory B Cell Lymphoma

NCT ID: NCT03258047

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-07-30

Brief Summary

It's a single arm, open label prospective study, in which the safety and efficacy of autologous CAR-T are evaluated in refractory/relapsed B cell lymphoma patients.

Abbreviation: CAR-T: Chimeric Antigen Receptor T-Cell Immunotherapy.

Conditions

B Cell Lymphoma

Study Design

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

Study Groups

CAR-T treatment

In this group, patients will be treated with autologous CAR-T, and the safety and efficacy will be evaluated

Group Type: EXPERIMENTAL

CAR-T

Intervention Type: COMBINATION_PRODUCT

CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.

Interventions

CAR-T

CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Age≥18 years, male or female;

2. Karnofsky≥60%；

3. B cell lymphoma patients who are not available for the following treatment: autologous stem cell transplantation, allogeneic stem cell transplantation, or patients with short expected survival (less than 2 years).

4. Patients with CR2 or CR3 and no stem cell transplantation available due to age, disease condition, lack of donors or any other reasons.

5. Patients have had more than 2 combined chemotherapy regimens;

6. Creatinin <2.5mg/dL；ALT/AST level <3 times of the maximum of normal range; bilirubin<3mg/dL；

7. Proper venous condition for leukapheresis, no contraindication for leukapheresis;

8. Patient that could understand and is willing to sign the written consent;

9. Fertile female patient should be willing to take contraceptive measures.

10. Patient that is willing to follow up till at least 2 months after T cell re-transfusion.

Exclusion Criteria

1. Patients who need ≥15mg prednisone daily due to any cause;

2. Patients with autoimmune disease and need immunosuppressor treatment;

3. Serum creatinin>2.5 mg/dL；serum AST >5 times of normal maximum; bilirubin >3 mg/Dl;

4. FEV1<2 L，diffusion capacity for carbon monoxide of lung (DLCO) <40%；

5. Cardiovascular abnormalities that fulfill any of the following: NYHA level III or IV congestive heart failure, severe clinical hypotention; uncontrollable carotid heart disease; or ejection fraction<35%；

6. Patients with HIV infection, active Hepatitis B or Hepatitis C infection;

7. Patients that have previously received gene therapy of any kind;

8. Obvious clinical encephalopathy or novel neuron function damage;

9. Patients with active infection;

10. Patients had biological treatment, immunotherapy or radiation therapy within 1 month prior to enrollment or are currently under these treatment;

11. Patients who had allergic history to agents of the similar structure as CAR-T;

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

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Wenbin Qian

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The first affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

lymphoma center Q002

Identifier Type: -

Identifier Source: org_study_id