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Completed

NCT Number: NCT05950334

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

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.

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Key information

Conditions

Relapsed/Refractory B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advent Health, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

FT522

Drug

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

Rituximab

Drug

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

Other names: RITUXAN, TRUXIMA, RUXIENCE, RIABNI

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.

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.

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.

Primary outcomes

  1. Number of participants with dose limiting toxicities (DLTs)

    Time frame: From Day 1 through Day 29 of Cycle 1

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

  2. Severity of DLTs

    Time frame: From Day 1 through Day 29 of Cycle 1

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

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to approximately 24 months

    Participants will be classified into the following tumor response categories: complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE) according to the Lugano 2014 criteria. The best overall response (BOR) will be summarized for the efficacy evaluable population. ORR is defined as the percentage of participants who achieve a PR or better during the study prior to any subsequent off-protocol anti-cancer therapy.

  2. Duration of Response (DOR)

    Time frame: Up to approximately 18 months

    The DOR is defined as the time from first objective response to disease progression or death from any cause.

  3. Duration of Complete Response (DOCR)

    Time frame: Up to approximately 18 months

    The DOCR is defined as the time from first CR to disease progression or death from any cause.

  4. Progression-Free Survival (PFS)

    Time frame: Up to approximately 18 months

    PFS is defined as the time from first study intervention to progressive disease or death from any cause.

  5. Overall Survival (OS)

    Time frame: Up to approximately 18 months

    OS is defined as the time from first dose of study intervention to death from any cause.

  6. Area Under the Plasma-Concentration Time Curve (AUC) of FT522

    Time frame: Cycle 1, Up to Day 29

    The plasma AUC of FT522 will be reported.

  7. Maximum Plasma Concentration (Cmax) of FT522

    Time frame: Cycle 1, Up to Day 29

    The plasma Cmax of FT522 will be reported.

Sponsors and collaborators

Lead sponsor

Fate Therapeutics

Industry

Registry information

Official study title

A Phase 1 Study of FT522 in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Lymphoma

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2023
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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