CD19-targeting CAR T Cells for B Cell Lymphoma

B Cell Lymphoma Clinical Trial

Official title:

CD19-targeting CAR T Cells for Refractory B Cell Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02547948
• Other study ID #: CD19-targeting CAR T
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 2015
• Est. completion date: August 15, 2016

Study information

• Verified date: July 2020
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.

Description:

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 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• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 15, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Relapsed or refractory CD19+ B-cell lymphoma.

2. Measurable disease.

3. Performance status ECOG 0-2.

4. Age:18-80.

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.

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• CD19-targeting CAR T Cells infusion
CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma

Locations

Country	Name	City	State
China	Central laboratory in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	B cell number and immunoglobulins	Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics	up to 24 months
Primary	CAR T cell persistence	Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood	up to 24 months
Secondary	Tumor load	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis	up to 24 months