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

NCT05950334 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-22

No results posted yet for this study

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

Interventions

DRUG

FT522

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

DRUG

Rituximab

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

DRUG

Cyclophosphamide

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.

DRUG

Fludarabine

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.

DRUG

Bendamustine

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.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Fate Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2025-06-06
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05950334 on ClinicalTrials.gov