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

Phase 2

• Conditions: B Cell Lymphoma
• Interventions: Combination Product: CAR-T

• Registration Number: NCT03258047
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-20
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-22
• Study Start: 2017-09-15
• Primary Completion: 2019-01-13
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Study Completion: 2019-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
complete remission rate	every 3 months until 20 months after the last patient's enrollment	complete remission rate after treated by CAR-T therapy

Secondary Outcome Measures

Name	Time	Method
adverse events	from the date of the start of treatment to 20 months after last patient's enrollment	any unfavorable and unintended sign , symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure
progression free survival	from the day of treatment to the date of first documented progression，up to 20 months after the last patient's enrollment	from date of inclusion to date of progression, relapse, or death from any cause
duration of the modified T cells by CAR-T in the patients	from the date of re-transfusison to 20 months after last patient's enrollment	time from re-transfusion to date when the modified T cells become non-detectable.
overall survival	20 months after the last patient's enrollment	from the date of inclusion to date of death, irrespective of cause

Trial Locations

Locations (1)

The first affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China