Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Lymphoma, Non-Hodgkin

Lymphosarcoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

B-cell Lymphoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Antibodies

Antibodies, Monoclonal

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Obinutuzumab

Bendamustine Hydrochloride

Rituximab

Immunoglobulins

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

FT596 monotherapy in adult subjects with r/r B-cell Lymphoma

FT596 in combination with Rituximab in adult subjects with r/r B-cell Lymphoma

FT596 in combination with Obinutuzumab in adult subjects with r/r B-cell Lymphoma

FT596 monotherapy in adult subjects with r/r CLL

FT596 in combination with Obinutuzumab in adult subjects with r/r CLL

FT596

Bendamustine

Fate Trial Disclosure

This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies

A Phase I, Open-Label, Multicenter Study of FT596 as a Monotherapy and in Combination With Rituximab or Obinutuzumab in Subjects With Relapsed/Refractory B-cell Lymphoma and Chronic Lymphocytic Leukemia

Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification for lymphomas, a partial remission (PR) or complete remission (CR) per revised iwCLL guidelines for CLL.

Defined as the duration from the first occurrence of a documented objective response (DOR) until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL.

Defined as the duration from the first occurrence of a documented complete response (CR) per Lugano 2014 classification for lymphomas or complete remission (CR) per revised iwCLL guidelines for CLL, until the time of disease progression or relapse, or death from any cause, whichever occurs first.

Defined as the time from from first dose of lympho-conditioning to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification for lymphomas or revised iwCLL guidelines for CLL

Fate Therapeutics

Lymphoma, Large B-Cell, Diffuse

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Diffuse Large B-Cell Lymphoma

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Anti-Inflammatory Agents

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

FT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.

FT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles

Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously

1.4 mg/m\^2 (maximum dose 2 mg) intravenously

This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.

This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.

The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.

Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose \[MAD\] in the absence of dose limiting toxicities \[DLTs\] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.

Subjects will be assigned to one of 2 treatment regimens corresponding to different schedules (standard or alternate) of R-CHOP

FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

Proportion of subjects who achieve a complete response (CR) per Lugano 2014 classification

Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification

Duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification

Duration from the first occurrence of a documented complete response (CR), per Lugano 2014 classification until the time of disease progression or relapse, or death from any cause, whichever occurs first

Time from first dose of study treatment to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification

Time from first dose of study treatment to death from any cause

Assessed by the detection of FT596 in peripheral blood following FT596 administration.

Up to three sequential FT596 dose levels are planned for Day 30 administration: (Dose Level 1: 9x10\^7 cells/dose, Dose Level 2: 3x10\^8 cells/dose, Dose Level 3: 9x10\^8 cells/dose with a Dose Level -1: 3x10\^7 cells/dose tested only if dose limiting toxicity events (DLT) occur at dose level 1).The maximum tolerated dose will be determined by using a modified continual reassessment method (CRM).

FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.

Rituximab 375 mg/m\^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion

Dr.Veronika Bachanova, MD, PhD

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.

Patients are enrolled in cohorts of 3 starting at Dose Level 1. There are three dose escalating doses of FT596. A minimum of 28 days will separate each cohort. For Dose Level 1 a minimum of 28 days will separate each patient to assess for dose limiting toxicity (DLT). In subsequent cohorts, the 1st and 2nd patient will be separated by at least 28 days and at least 14 days will separate the 2nd and 3rd patient.

Each new cohort of three patients will be sequentially assigned to the most appropriate dose based on the updated toxicity probabilities under the continuous reassessment method (CRM), and the MTD will be identified when the total sample size of 18 is exhausted or 6 patients are sequentially enrolled at the same dose.

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

FATE FT596 With Rituximab as Relapse Prevention in High Risk Patients After Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin Lymphoma

The component I design (FT596 on day 30) will continue until the MTD is declared or until the first dose is declared to be above MTD. The component I dose limiting toxicity (DLT) is defined as any of the following events within 28 days after the FT596 dosing based on CTCAE v5:Grade 4 hematologic toxicity lasting \> 7 days ,Grade 4 non-hematologic toxicity ,Grade ≥3 Infusion Related Reaction, Grade 2 acute GVHD that requires steroid therapy \>7 days or progression after 3 days of steroids or has partial response after 14 days of treatment, Grade ≥3 acute GVHD, Grade 4 cytokine release syndrome (CRS), Grade 3 CRS that does not resolve to \< Grade 2 in 72 hours, Grade 3 neurotoxicity, Grade 3 organ toxicity involving vital organs, Any Grade 3 non-hematological toxicity that does not resolve to ≤Grade 2 within 72 hours

Number of participants experiencing adverse events related to FT596 post auto-HSCT in combination with rituximab

Number of participants experiencing progression or relapse at 12 months post auto HSCT

Number of participants experiencing non-relapse mortality at 100 days post auto-HSCT.

Number of participants experiencing non-relapse mortality at one year post auto-HSCT.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies	NCT04245722	Lymphoma, B-Cel... Chronic Lymphoc...	FT596 Cyclophosphamid... Fludarabine Rituximab Obinutuzumab Bendamustine	18 Years -	Fate Therapeutics
FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma	NCT05934097	Diffuse Large B... Transformed Ind... Follicular Lymp... Mantle Cell Lym... Marginal Zone L...	FT596 Cyclophosphamid... Doxorubicin Vincristine Prednisone Rituximab Bendamustine	18 Years -	Fate Therapeutics
FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies	NCT04245722	Lymphoma, B-Cel... Chronic Lymphoc...	FT596 Cyclophosphamid... Fludarabine Rituximab Obinutuzumab Bendamustine	18 Years -	Fate Therapeutics
FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies	NCT04245722	Lymphoma, B-Cel... Chronic Lymphoc...	FT596 Cyclophosphamid... Fludarabine Rituximab Obinutuzumab Bendamustine	18 Years -	Fate Therapeutics
FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma	NCT05934097	Diffuse Large B... Transformed Ind... Follicular Lymp... Mantle Cell Lym... Marginal Zone L...	FT596 Cyclophosphamid... Doxorubicin Vincristine Prednisone Rituximab Bendamustine	18 Years -	Fate Therapeutics
FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL	NCT04555811	NHL Non Hodgkin Lym... Diffuse Large B... High-grade B-ce...	FT596 Rituximab	18 Years -	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for ft596

Every month we try and update this database with for ft596 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ft596

Every month we try and update this database with for ft596 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ft596 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.