a study evaluating the safety of cal-1 (lvsh5/c46) drug product in hiv-1 infected patient with high risk lymphoma

Conditions: HIV-1 Infection

Summary: the purpose of this study is to evaluate the safety and the feasibility, and the success of engraftment of the introduction of cal-1 gene-transduced haematopoietic cell populations (ttn and hspctn) in patients with hiv-1-related high-risk lymphoma.

not provided

Eligibility criteria:
inclusion criteria: eligible subjects will undergo screening assessments at three time points: * screening 1 at the beginning of chemotherapy, * screening 2 (first "check-point") after the harvest for cd34, * screening 3 (second "check-point") before the asct procedure. potential subjects must satisfy all of the inclusion criteria to be enrolled in the study and proceed with the first apheresis (day -39). in-a. prior to any study-related procedures, signed informed consent indicating that they understand the purpose, risks and procedures required for the study and are willing to participate in the study in-b. individuals aged 18 to 60 years of age (inclusive) at time of consent in-c. women with child-bearing potential must be on adequate effective contraception (continuous progestative contraception) in-d. documented hiv-1 infection at or before the time of lymphoma diagnosis in-e. treatment with antiretroviral agents (excluding nnrti) introduced or optimized at the time of screening in-f. biopsy-proven lymphoma meeting one of the following criteria: 1. 1. intermediate- or high-grade b-cell non-hodgkin lymphoma, meeting 1 of the following criteria: * in first complete remission with high-risk features such as t-cell lymphoma and plasmablastic lymphoma (after multidisciplinary consultation regarding the indication of asct in this context). the decision of asct is independent of the present clinical trial. * in partial remission * relapsed after initial complete remission * failed induction therapy but responds to salvage therapy (i.e., chemosensitive disease) 2. hodgkin lymphoma, meeting 1 of the following criteria: * in first or greater relapse after initial complete remission * in partial remission * failed induction therapy but responds to salvage therapy (i.e. chemosensitive disease) 3. high-risk lymphoma requiring a treatment with combined chemotherapy and autologous stem cell transplantation (asct) exclusion criteria: ex-a. -left ventricular ejection fraction \<50% at screening 1: ex-b. abnormal biochemistry at screening 1: alanine and/or aspartate aminotransferase (alt/ast) \>10 x upper limit of normal (uln) total bilirubin \> 2.5 x uln creatinine clearance \ 2x uln ex-e. evidence of co-infection with hepatitis b virus (hbsag+), hepatitis c virus, west nile virus, or human t-lymphotropic virus (htlv-1) as detected at screening 1 ex-f. stay in west nile virus endemic area less than 6 weeks prior to cd34+ collection ex-g. evidence of non-treated opportunistic infection during the pre-infusion period ex-h. evidence of not-treated cns involvement of lymphoma at screening 1 ex-i. isolated cns relapse of the lymphoma without other evidence of active disease at screening 1 ex-j. known hypersensitivity to g-csf (neupogen™) or plerixafor (mozobil™) ex-k. evidence of uncontrolled hiv-1 viremia at screening 2 and/or 3 (plasma hiv-1 rna ≥ 1.000 copies/ml confirmed in 2 successive blood samples) ex-l. evidence of chemoresistant lymphoma at screening 2 ex-m. any contra-indication to asct at any time during the pre-infusion period ex-n. participation in any study involving any investigational drug or medical device within 3 months prior to screening 1 ex-o. receipt of a vaccine for hiv-1 or any gene transfer product at any time ex-p. subjects who will not accept transfusions of blood products ex-q. pregnant or breast-feeding woman at any time ex-r. woman of child-bearing potential not under adequate contraceptive protection at any time ex-s. inability to understand and provide informed consent psychological or psychiatric disability thought to be clinically significant in the opinion of the investigator

Keywords: hiv-1 lymphoma gene therapy