T cell therapy for patients with leukemia or lymphoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Patients may be included in the study only if they meet all of the following criteria:

1)Relapsed or refractory CD19+ B-cell lymphoma or leukemia
2)Measurable disease.
3)Performance status ECOG 0-2.
4)>18 years old.
5)Fertile females/males must consent to use contraceptives during participation of the trial.
6)Adequate bone marrow, renal, hepatic and cardiovascular function.
7)Signed informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

The presence of any of the following criteria will exclude the patient from participating in the study:

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the feasibility of a single administration of CAR T cells to patients with disseminated B cell lymphoma or leukemia by studying the tolerance and toxicity.;Secondary Objective: To:<br>- establish persistence of CAR T cells<br>- evaluate the level of B cells as a measurement of CAR T cell efficacy<br>- evaluate immune profile shifts post treatment as a measurement of CAR T cell function<br>- tumor response;Primary end point(s): Registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events.<br>;Timepoint(s) of evaluation of this end point: Weekly the first 5 weeks, then at 3, 6, 9 and 12 months.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Determination of the level of CAR T cells (mRNA and cells) in blood and biopsies.<br>- Determination of the levels of circulating B cells.<br>- Determination of the presence of immunological markers in blood and biopsies.<br>- Determination of tumor size and the tumor marker CD19.;Timepoint(s) of evaluation of this end point: At week 5 and then at 3 and 9 months