What side effects are associated with this type of intervention?

Common treatments for B-Cell Lymphoma, including engineered T-cell therapies like FT819, often have side effects such as cytokine release syndrome (CRS), which can cause fever, nausea, headache, rash, rapid heartbeat, low blood pressure, and trouble breathing. Other treatments, such as chemotherapy (e.g., bendamustine, cyclophosphamide) and monoclonal antibodies (e.g., rituximab), can lead to side effects like infusion reactions, increased risk of infections, fatigue, nausea, and hematologic toxicities such as neutropenia and thrombocytopenia. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several CAR-T cell therapies for the treatment of B-Cell Lymphoma. Notable approvals include axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah), both of which are engineered T-cell therapies targeting the CD19 antigen on B-cells. These therapies have shown significant efficacy in treating relapsed or refractory B-Cell Lymphomas. Additionally, brexucabtagene autoleucel (Tecartus) has been approved for mantle cell lymphoma, a subtype of B-Cell Lymphoma. These treatments represent a significant advancement in the management of B-Cell Lymphomas, offering new options for patients with difficult-to-treat disease.

What other types of research exist?

Promising novel alternatives to FT819 for B-Cell Lymphoma patients include: 1) YM155 plus rituximab, which targets survivin and has shown efficacy in relapsed aggressive B-cell NHL; 2) Antibody-drug conjugates (ADCs), which are advancing rapidly and offer targeted therapy options; 3) Reduced intensity or nonmyeloablative hematopoietic cell transplantation (HCT), which has shown potential benefits in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

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CAR T-cell Therapy

FT819 for Blood Cancer

Phase 1

Waitlist Available

Research Sponsored by Fate Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Diagnosis of CLL per iwCLL guidelines

- Relapsed/refractory disease following at least two prior systemic treatment regimens

Must not have

- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease

- Receipt of an allograft organ transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up study days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called FT819, alone or with IL-2, in patients with certain blood cancers that have not responded to other treatments. FT819 targets cancer cells, and IL-2 boosts the immune system.

Who is the study for?

Adults over 18 with certain B-cell blood cancers (like lymphoma, chronic leukemia, or acute leukemia) that have come back or didn't respond to at least two previous treatments can join. They must be able to consent and follow the study plan, and use birth control as required.

What is being tested?

The trial is testing FT819 alone or with IL-2 in patients whose B-cell malignancies have relapsed or are resistant to treatment. It's a Phase I study where they'll first find the right dose and then see how well it works in specific groups of patients.

What are the potential side effects?

Possible side effects may include reactions related to immune system activation, such as fever and fatigue; organ inflammation; infusion-related reactions; bone marrow suppression leading to low blood cell counts; and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with chronic lymphocytic leukemia.

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My condition did not improve after two different treatments.

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I am 18 years old or older.

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My cancer returned or didn't respond after 2+ standard treatments. If my cancer is Ph+, I also couldn't tolerate or didn't respond to a specific drug therapy.

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I have been diagnosed with B-ALL through specific tests.

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I have been diagnosed with a type of B-cell blood cancer.

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My lymphoma is confirmed to express CD19.

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My condition did not improve after 2 different cancer treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have non-cancerous brain conditions like stroke or epilepsy.

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I have received an organ transplant from another person.

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I am currently on or might need drugs that weaken my immune system.

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I have tested positive for Hepatitis B.

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I have a serious heart condition.

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My body weight is less than 50 kg.

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I need continuous treatment for GvHD after a stem cell or CAR-T transplant.

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My cancer has spread to my brain or spinal cord.

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I am not pregnant or breastfeeding.

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My daily activity is limited due to my health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~study days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and study days 1, 2, 3, 4, 5, 8, 11, 15, 22, and 29 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Determination of the pharmacokinetics of FT819 cells in peripheral blood.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

12Treatment groups

Experimental Treatment

Group I: FT819 Step Fractionated Monotherapy, CLLExperimental Treatment4 Interventions

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r CLL

Group II: FT819 Step Fractionated Monotherapy, B-Cell LymphomaExperimental Treatment4 Interventions

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-cell Lymphoma

Group III: FT819 Step Fractionated Monotherapy, B-ALLExperimental Treatment4 Interventions

FT819 monotherapy administered as step-fractionated dosing in adult subjects with r/r B-ALL

Group IV: FT819 Step Fractionated Monotherapy in Combination with IL-2, CLLExperimental Treatment5 Interventions

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r CLL

Group V: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-Cell LymphomaExperimental Treatment5 Interventions

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-cell Lymphoma

Group VI: FT819 Step Fractionated Monotherapy in Combination with IL-2, B-ALLExperimental Treatment5 Interventions

FT819 monotherapy administered as step-fractionated dosing in combination with IL-2 in adult subjects with r/r B-ALL

Group VII: FT819 Single-Dose in Combination with IL-2, CLLExperimental Treatment5 Interventions

FT819 single-dose in combination with IL-2 in adult subjects with r/r CLL

Group VIII: FT819 Single-Dose in Combination with IL-2, B-Cell LymphomaExperimental Treatment5 Interventions

FT819 single-dose in combination with IL-2 in adult subjects with r/r B-cell Lymphoma

Group IX: FT819 Single-Dose in Combination with IL-2, B-ALLExperimental Treatment5 Interventions

FT819 single-dose in combination with IL-2 in adult subjects with r/r B-ALL

Group X: FT819 Single-Dose Monotherapy, CLLExperimental Treatment4 Interventions

FT819 single-dose monotherapy in adult subjects with r/r CLL

Group XI: FT819 Single-Dose Monotherapy, B-Cell LymphomaExperimental Treatment4 Interventions

FT819 single-dose monotherapy in adult subjects with r/r B-cell Lymphoma

Group XII: FT819 Single-Dose Monotherapy, B-ALLExperimental Treatment4 Interventions

FT819 single-dose monotherapy in adult subjects with r/r B-ALL

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bendamustine

2015

Completed Phase 3

~3230

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860

IL-2

2007

Completed Phase 4

~1100

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for B-Cell Lymphoma include monoclonal antibodies (e.g., rituximab), which target CD20 on B-cells, and chemotherapy agents like bendamustine, which damage DNA in cancer cells. Engineered T-cell therapies, such as those studied in the FT819 trial, involve modifying T-cells to better recognize and attack cancer cells. These therapies are significant for B-Cell Lymphoma patients as they offer targeted approaches that can potentially improve response rates and reduce side effects compared to traditional treatments.