ft596 with rituximab as relapse prevention after autologous hsct for nhl

Conditions: NHL; Non Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; High-grade B-cell Lymphoma

Summary: this is a phase i multi-center study to evaluate the safety of ft596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-hsct) for diffuse large or high-grade b cell lymphoma.

this study uses a single dose of the investigational product ft596 in the early post-transplant period. rituximab or an fda approved by biosimilar including rituxan®, truxima®, and ruxience™ is given 48 to 72 hours prior to ft596. the goal of this study is to 1) establish a maximum tolerated dose (mtd) of ft596 when given 30 days after transplant and 2) to confirm the mtd and safety of giving a single dose of ft596 at day 7 post-transplant starting at one dose level below the mtd identified at day 30.

Eligibility criteria:
inclusion criteria: * diagnosis of diffuse large b cell lymphoma or aggressive (high-grade) b-cell lymphoma for which an autologous stem cell transplant is planned or recently completed * high risk for relapse defined as at least one of the below: * primary induction failure (no complete or partial remission at any point after diagnosis * initial remission duration \< 12 months * lack of complete metabolic (pet scan) response after 2-3 cycles of salvage chemotherapy * evidence of c-myc and bcl-2 and/or bcl-6 re-arrangement (double hit or triple hit lymphoma) * age-adjusted ipi 2-3 at relapse * age 18 years or older at the time of signing consent. * agrees to use adequate contraception (or evidence of sterility) for at least 12 months after the last dose of rituximab. * agrees and signs the separate consent for up to 15 years of follow-up (long-term follow-up study cprc#2020ls052) * provides voluntary written consent prior to the performance of any research related activities. exclusion criteria: * receipt of any investigational therapy within 28 days prior to the first dose of ft596 or planned use of an investigational therapy during the first 100 days after transplant * planned post-transplant irradiation prior to day +100 * seropositive for hiv, active hepatitis b or c infection with detectable viral load by pcr * body weight \<50kg * known allergy to the following ft596 components: albumin (human) or dmso * unable to receive rituximab post-hsct reconfirmation of eligibility * no life-threatening medical issues (i.e. ongoing grade 4 adverse events) where, in the opinion of the treating investigator, use of ft596 is not in the patient's best interest. * no active uncontrolled infection. * adequate organ function post-transplant including: * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤5 x uln (grade 2 ctcae v5) * total bilirubin ≤1.5 x uln (grade 1 ctcae v5) * serum creatinine ≤1.5 x uln (grade 1 ctcae v5) * oxygen saturation ≥93% on room air * for day 30 dosing only - cbc requirement consistent with engraftment (anc\>500, platelet\>20,000 without transfusion support within previous 7 days). there are no cbc parameters for day 7 dosing. * no requirement for systemic immunosuppressive therapy (\> 5mg prednisone daily) during the ft596 dosing period.

Keywords: auto hsct stem cell transplantation lymphoma