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Relapsed/Refractory B-Cell LymphomaPhase 1NCT05950334

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

A Phase 1 study testing FT522, Rituximab and Cyclophosphamide in people with Relapsed/Refractory B-Cell Lymphoma, run by Fate Therapeutics at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory B-Cell Lymphoma
What is being tested?
FT522, Rituximab and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
7 sitesUnited States
Study dates
16 Nov 2023to 30 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Karmanos Cancer Center

    Detroit, Michigan, 48201

  • Baylor Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Minnesota Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Advent Health

    Orlando, Florida, 32803

Other trials in United States

About this study

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

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.

Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FT522Drug

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

  • RituximabDrug

    Also called RITUXAN, TRUXIMA, RUXIENCE, RIABNI

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

  • CyclophosphamideDrug

    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.

  • FludarabineDrug

    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.

  • BendamustineDrug

    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.

Study groups in NCT05950334
Study groupRoleWhat they receive
Regimen AExperimentalParticipants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) with chemotherapy.
Receives: Drug: FT522; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
Regimen BExperimentalParticipants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) without chemotherapy.
Receives: Drug: FT522; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: From Day 1 through Day 29 of Cycle 1

  2. 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).

    Measured: From Day 1 through Day 29 of Cycle 1

Secondary outcomes (7)

  1. Overall Response Rate (ORR)

    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.

    Measured: Up to approximately 24 months

  2. Duration of Response (DOR)

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

    Measured: Up to approximately 18 months

  3. Duration of Complete Response (DOCR)

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

    Measured: Up to approximately 18 months

  4. Progression-Free Survival (PFS)

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

    Measured: Up to approximately 18 months

  5. Overall Survival (OS)

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

    Measured: Up to approximately 18 months

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

    The plasma AUC of FT522 will be reported.

    Measured: Cycle 1, Up to Day 29

  7. Maximum Plasma Concentration (Cmax) of FT522

    The plasma Cmax of FT522 will be reported.

    Measured: Cycle 1, Up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2023
  2. Study start16 Nov 2023
  3. Primary completion6 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Participants will be enrolled first into a dose-escalation stage, followed by a dose optimization stage, and a dose-expansion stage.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05950334
Sponsor's protocol ID
FT522-101
Status last verified
Jul 2024
First submitted
10 Jul 2023
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FT522, Rituximab and Cyclophosphamide in people with Relapsed/Refractory B-Cell Lymphoma, run by Fate Therapeutics at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose limiting toxicities (DLTs) (time frame: From Day 1 through Day 29 of Cycle 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05950334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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