Clinical Trial

Disease: Relapsed or Refractory B-Cell Malignancies, (NCT04629729)

Disease info:

B-cell malignancies are cancers that arise from abnormalities in B cells, and include B-cell lymphomas and leukaemias. While leukaemias typically originate in the bone marrow and spread through the bloodstream, lymphomas usually originate in the lymph nodes or the spleen and spread through the lymphatic system.

There are more than 70 known types of B-cell lymphoma, and these make up approximately 85 % of all cases of non-Hodgkin lymphomas in the United States. NHL is one of the most common cancers in the United States, accounting for about 4% of all cancers. B-cell lymphomas may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms. Other common types of B-cell lymphoma include:

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma
  • Chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL)
  • Mantle cell lymphoma (MCL)
  • Marginal zone lymphomas
  • Burkitt lymphoma

In leukaemia, the bone marrow produces abnormal levels of white blood cells. B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive leukaemia in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. B-ALL is the most common type of ALL. Note that B-ALL is also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia. 

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.

 

Frequency:
NHL accounts for about 4% of all cancers in the U.S. The American Cancer Society estimates 80,550 people will be diagnosed with NHL in 2023. ALL accounts for less than 1% of all cancers in the U.S., with 6,540 new cases estimated in the U.S. in 2023.
Official title:
A Phase I Study of FT819 in Subjects With B-cell Malignancies
Who:

Contact: Fate Trial Disclosure

Phone: 866-875-1800

Email: FateTrialDisclosure@fatetherapeutics.com
 

Sponsor:

Fate Therapeutics

Partners:
Locations:

United States, Alabama

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35294

 

United States, California

UCLA Ronald Reagan Medical Center, Los Angeles, California, United States, 90095

Stanford Cancer Institute, Palo Alto, California, United States, 94304

 

United States, Iowa

University of Iowa, Iowa City, Iowa, United States, 52242

 

United States, Kansas

The University of Kansas Medical Center, Westwood, Kansas, United States, 66205

 

United States, Kentucky

Norton Cancer Institute, St. Matthews Campus, Louisville, Kentucky, United States, 40207

 

United States, Nebraska

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

 

United States, New Jersey

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

 

United States, New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10021

 

United States, Oregon

Oregon Health & Sciences University, Portland, Oregon, United States, 97239

 

United States, Texas

MD Anderson Cancer Center, Houston, Texas, United States, 77030

 

United States, Wisconsin

University of Wisconsin-Madison, Madison, Wisconsin, United States, 53705

Study start:
Jul. 6, 2021
Enrollment:
396 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out, gene knock-in
Gene:
Anti-CD19 molecule , T Cell Receptor Alpha Constant (TRAC)
Delivery method:
Electroporation and adeno-associated virus (AAV) - Ex-vivo
Trial link:
https://clinicaltrials.gov/ct2/show/record/NCT04629729
Safety updates:

(10-12-2022) Fate Therapeutics Announces Clinical Safety and Activity Data of First-ever iPSC-derived CAR T-cell Therapy at 2022 ASH Annual Meeting

(02-08-2021) Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-Cell Therapy

(09-07-2020) Fate Therapeutics Announces FDA Clearance of IND Application for First-ever iPSC-derived CAR T-Cell Therapy

Other links:

LinkB-cell lymphoma disease informationLinkFrequency of B-cell lymphomaLinkFT819: Translation of Off-the-Shelf TCR-Less Trac-1XX CAR-T Cells in Support of First-of-Kind Phase I Clinical TrialLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem QasimLinkOff-the-shelf Cell-based Cancer Immunotherapy Developing First-of-kind Cell Products using Clonal Master iPSC LinesLinkGene-Editing Clinical Trial Update

Note:
FT819 is an off-the-shelf CAR T-cell cancer immunotherapy derived from a clonal engineered master iPSC line with a novel 1XX CAR targeting CD19 inserted into the T cell receptor alpha constant (TRAC) locus and edited for elimination of T cell receptor (TCR) expression.
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active not recruiting

Description

This is a Phase I dose-finding study of FT819, either as monotherapy or in combination with IL-2 in subjects with relapsed/refractory B-cell lymphoma, chronic lymphocytic leukaemia and precursor B-cell acute lymphoblastic leukaemia (B-ALL). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

FT819 is developed using precise genetic engineering and multiple targeting events at the single cell level, and it is derived from a clonally-derived master cell bank (MCB) that serves as the starting material to support consistent and reproducible clinical manufacturing. The engineered features of FT819 include the targeted integration of a novel CD19 1XX-CAR into the T cell receptor α constant (TRAC) locus to provide antigen specificity, enhanced efficacy and temporally-regulated CAR expression driven by an endogenous (TCR) promoter. Such features are designed to also eliminate the possibility of graft versus host disease (GvHD) by nullifying the TCR.

Last updated: Dec. 12, 2024
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