FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)

NCT05950334 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: FT522-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 7

Brief Summary

This is a phase 1 study of FT522 administered with rituximab in participants with relapsed/refractory B-cell lymphoma (R/R BCL). The primary objectives of the study are to evaluate the safety and tolerability of FT522 in combination with rituximab, and to determine the recommended phase 2 dose (RP2D) of FT522 in combination with rituximab; each objective will be assessed with or without conditioning chemotherapy.

Conditions

Relapsed/Refractory B-Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose limiting toxicities (DLTs)

  The number of participants experiencing ≥1 DLT will be reported.

  From Day 1 through Day 29 of Cycle 1

• Severity of DLTs

  The severity of DLTs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE, v5.0).

  From Day 1 through Day 29 of Cycle 1

Secondary Outcomes (7)

• Overall Response Rate (ORR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 18 months

• Duration of Complete Response (DOCR)

  Up to approximately 18 months

• Progression-Free Survival (PFS)

  Up to approximately 18 months

• Overall Survival (OS)

  Up to approximately 18 months

Study Arms (2)

Regimen A

EXPERIMENTAL

Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) with chemotherapy.

Drug: FT522; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine

Regimen B

EXPERIMENTAL

Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) without chemotherapy.

Drug: FT522; Drug: Rituximab

Interventions

FT522 DRUG

FT522 drug product is administered as an intravenous infusion on Days 1, 4 and 8 of a treatment cycle.

Regimen A; Regimen B

Rituximab DRUG

Rituximab will be administered as an IV infusion on Day -4 of the treatment cycle.

Also known as: RITUXAN, TRUXIMA, RUXIENCE, RIABNI

Regimen A; Regimen B

Cyclophosphamide DRUG

Cyclophosphamide will be administered as an IV infusion at a dose of 500 mg/m\^2 on Day -5, Day -4, and Day -3 of the treatment cycle.

Regimen A

Fludarabine DRUG

Fludarabine will be administered as an IV infusion at a dose of 30 mg/m\^2 on Day -5, Day -4, and Day -3 of the treatment cycle.

Regimen A

Bendamustine DRUG

Bendamustine will be administered as an IV infusion at a dose of 90 mg/m\^2 on Day -5 and Day -4 of the treatment cycle. Bendamustine may be administered as an alternative to cyclophosphamide/fludarabine.

Regimen A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of B-cell lymphoma (BCL) as: (1) histologically documented lymphomas expected to express CD19 and CD20, including Grades 1 to 3B follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenstrom macroglobulinemia (WM), mantle cell lymphoma (MCL), transformed indolent non-Hodgkin lymphoma (tNHL), diffuse large B-cell lymphoma (DLBCL) \[not otherwise specified\], high-grade BCL, primary mediastinal BCL, and Richter transformation (RT; expansion part of study only); (2) R/R disease following at least 1 prior systemic regimen containing an anti-CD20 monoclonal antibody (mAb) for which the participant has no available curative treatment options; and (3) evaluable F-fluorodeoxyglucose (FDG)-avid disease, or measurable disease defined by at least one bi dimensionally measurable lesion
• Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception

You may not qualify if:

• Females who are pregnant or breastfeeding
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
• Body weight \<50 kg
• Evidence of insufficient organ function
• Receipt of any biological therapy, chemotherapy (except for rituximab), or any investigational therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or localized radiation therapy to a target lesion within 14 days prior to Day 1
• Currently receiving or likely to require systemic immunosuppressive therapy, e.g., prednisone \>5 mg daily, for any reason from Day -5 to Day 29, with the exception of corticosteroids as a pre medication required for conditioning chemotherapy or rituximab
• Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic chimeric antigen receptor (CAR) T-cell therapy within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host disease (GvHD) therapy
• Receipt of an allograft organ transplant
• Non-malignant central nervous system (CNS) disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
• Clinically significant cardiovascular disease
• Clinically significant infections
• Receipt of a live vaccine \<6 weeks prior to start of study intervention
• Known allergy to human albumin or DMSO
• Any medical condition or clinical laboratory abnormality that per investigator or medical monitor judgement, precludes safe participation in and completion of the study, or that could affect compliance with protocol conduct or interpretation of results

Sponsors & Collaborators

• Fate Therapeutics: lead

Study Sites (7)

Advent Health

Orlando, Florida, 32803, United States

Location

Karmanos Cancer Center

Detroit, Michigan, 48201, United States

Location

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Baylor Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Rituximab; Cyclophosphamide; fludarabine; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Fate Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The initial dose escalation stage of the study is nonrandomized; the dose optimization stage is randomized; the dose expansion stage is nonrandomized.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be enrolled first into a dose-escalation stage, followed by a dose optimization stage, and a dose-expansion stage.

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 18, 2023
• Study Start: November 16, 2023
• Primary Completion: June 6, 2025
• Study Completion: June 30, 2025
• Last Updated: August 22, 2025

Record last verified: 2024-07

Locations

US (7)