T cell therapy for patients with leukemia or lymphoma

Phase 1

• Conditions: CD19+ B cell lymphoma or leukemia; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-004043-36-SE
• Lead Sponsor: ppsala University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-26
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 25

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 <1% when used consistently and correctly. Highly effective contraceptives include combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation via e.g. oral, transdermal or intravaginal administration. Also included are progesterone-only hormonal contraception associated with inhibition of ovulation via e.g. oral, injectable or implantable administration. Other acceptable methods include intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner and sexual abstinence. Methods not included are e.g. condoms, diaphragm with spermicide and low-dose progesterone.

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified