Pilot Study of Anti-CD20-CAR-engineered T Cells in Patients With Chemotherapy Resistant or Refractory CD20+ Lymphoma

Lymphoma, B-Cell Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02965157
• Other study ID #: EY201605-19
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 31, 2016
• Last updated: November 14, 2016
• Start date: August 2016

Study information

• Verified date: August 2016
• Source: Beijing Biohealthcare Biotechnology Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Chimeric antigen receptor (CAR) T cells targeting CD20 will be evaluated for safety and efficacy in patients with CD20+ B cell lymphoma. The CAR consists of a CD20 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Relapsed or refractory CD20+ B-cell lymphoma.

2. Measurable disease.

3. Performance status ECOG 0-2.

4. Age:18-65.

5. Fertile females/males must consent to use contraceptives during participation of the trial.

6. Signed informed consent

Exclusion Criteria:

1. Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.

2. Patients with primary CNS lymphoma.

3. Known human immunodeficiency virus (HIV) infection.

4. Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).

5. Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.

6. Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.

7. Patients that do not consent to that tissue and blood samples are stored in a biobank.

8. Pregnancy.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• CART20

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences Tumor Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Biohealthcare Biotechnology Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		one year	No