CD19+ B cell lymphoma or leukemia
Conditions
Interventions
Product Name: 3rd generation anti-CD19 CAR T cells
Product Code: 3rdCARTa19
Pharmaceutical Form: Solution for infusion
Sponsors
Uppsala University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Relapsed or refractory CD19+ B-cell lymphoma, leukemia or Hodgkin lymphoma with no other curative treatment option available. 2. Measurable disease 3. All ages 4. Performance status ECOG 0-2 (Appendix IV) 5. Fertile females/male must consent to use highly effective* contraceptives during the participation of the trial 6. Signed informed consent * This study follows the 2014 CTFG guidance document “Recommendations related to contraception and pregnancy testing in clinical trials” (Appendix XII). The patients must consent to use highly effective contraceptives during the participation of the trial. Contraceptive methods considered highly effective by the guidance document are those with a Pearl index =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 to perform the treatment 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. Pregnancy 8. Patients that do not consent to that tissue and blood samples are stored in a biobank 9. Patients whose cells cannot be manufactured
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the feasibility and safety of two administrations of CAR T cells to patients with disseminated B cell lymphoma or leukemia. - To evaluate long-term toxicity of CAR T cells by an extended follow-up period (12-24 months) when patients are analyzed even if they have progressed in their disease and/or received another therapy. - To evaluate whether two courses of gemcitabine given in association with CAR T cells can increase the effect of CAR T cell therapy. ; Secondary Objective: - Establish persistence and function of CAR T cells. - To evaluate if FDG-PET MRI is a suitable technique to determine therapy response - Evaluate the level of B cells as a measurement of CAR T cell efficacy. - Evaluate immune profile shifts post treatment as a measurement of CAR T cell function. ; Primary end point(s): - Registration of the safety profile such as inflammation, fever, pain, changes in blood pressure, pulse and other adverse events. - Tumor response measured as best response and over all response. ;Timepoint(s) of evaluation of this end point: Weekly the first 6 weeks, then at 3, 6, 9, 12, 15, 18, 21 and 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Determination of the level of CAR T cells (mRNA and cells) in blood and biopsies. - Determination of activation markers on CAR T cells such as CD107a. - Determination of tumor size and the tumor marker CD19. - Determination of the levels of circulating B cells. - Determination of the presence of immunological markers in blood and biopsies. ;Timepoint(s) of evaluation of this end point: At 1 and 3 weeks then at 3, 6, 9, 12, 15, 18, 21 and 24 months. | — |
Countries
Sweden
Contacts
Public ContactTrial Manager
Uppsala University
Outcome results
None listed