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

Conditions

• Relapsed/Refractory B-Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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.

Study Details

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.

Key Dates

Start date

Nov 16, 2023

Status verified

Jul 2024

Primary completion

Jun 6, 2025

Completion

Jun 30, 2025

Study Design

Enrollment

20 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Regimen A
  Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) with chemotherapy.
• Experimental: Regimen B
  Participants receive FT522 in combination with rituximab (or a rituximab biosimilar approved by a local health authority) without chemotherapy.

Primary Outcome Measure

Number of participants with dose limiting toxicities (DLTs) [ Time Frame: From Day 1 through Day 29 of Cycle 1 ]

Locations (7)

Find similar trials in Orlando, FL