AzTrials
AzTrials

Diffuse Large B Cell LymphomaPhase 1NCT05934097

FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

A Phase 1 study testing FT596, Cyclophosphamide and Doxorubicin in people with Diffuse Large B Cell Lymphoma and Transformed Indolent Non-Hodgkin's Lymphoma, run by Fate Therapeutics.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
FT596, Cyclophosphamide and Doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2022to May 2039
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 described below:
  • Histologically documented BCL
  • Previously untreated or no more than one prior systemic therapy for BCL
  • At least one bi-dimensionally measurable lesion
  • Subjects with >1 measurable lesion agreement to undergo a biopsy
  • Capable of giving signed informed consent
Show all 10Show fewer
  • Age ≥ 18 years old
  • Stated willingness to comply with study procedures through study duration
  • Contraception use for women and men as defined in the protocol
  • Negative serum pregnancy test within 7 days of treatment for women

Who cannot join

  • Prior anthracycline therapy
  • Females who are pregnant or breastfeeding
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
  • Evidence of insufficient organ function
  • Currently receiving or likely to receive systemic immunosuppressive therapy
  • Receipt of allograft organ transplant
Show all 13Show fewer
  • Known active central nervous system (CNS) involvement by malignancy
  • Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  • Clinically significant cardiovascular disease
  • Positive HIV test
  • Positive Hepatitis B (HBV) or Hepatitis C (HCV) test
  • Live vaccine <6 weeks prior to start of conditioning
  • Allergy to human albumin or dimethyl sulfoxide (DMSO)

About this study

Official title: A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.

Read the detailed description

This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment.

The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule.

Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose [MAD] in the absence of dose limiting toxicities [DLTs] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.

Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

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

  • FT596Drug

    Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously

  • CyclophosphamideDrug

    750 mg/m^2 intravenously

  • DoxorubicinDrug

    50 mg/m^2 intravenously

  • VincristineDrug

    1.4 mg/m^2 (maximum dose 2 mg) intravenously

  • PrednisoneDrug

    100 mg orally

  • RituximabDrug

    Also called Rituxan, Truxima, Ruxience

    375 mg/m^2 intravenously

  • BendamustineDrug

    Also called Bendeka, Treanda

    90 mg/m^2 IV infusion

Study groups in NCT05934097
Study groupRoleWhat they receive
Regimen A (FT596 in combination with standard schedule R-CHOP)ExperimentalFT596 in combination with standard schedule R-CHOP (rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 1; prednisone on Days 1-5; and FT596 on Day 8) for a total of six 21-day cycles.
Receives: Drug: FT596; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab; Drug: Bendamustine
Regimen B (FT596 in combination with alternate schedule R-CHOP)ExperimentalFT596 in combination with alternate schedule R-CHOP (prednisone on Days 1-5; rituximab, cyclophosphamide, doxorubicin, and vincristine on Day 5; and FT596 on Day 8) for a total of six 21-day cycles
Receives: Drug: FT596; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Rituximab; Drug: Bendamustine

What is being measured

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

  1. Incidence of dose-limiting toxicities within each dose escalation cohort

    Measured: Day 21

  2. Nature of dose-limiting toxicities within each dose escalation cohort

    Measured: Day 21

  3. Incidence, nature, and severity of adverse events (AEs) of FT596 in combination with R-CHOP in B-cell lymphoma previously untreated or no more than one previous line of therapy with severity determined according to NCI CTCAE, v5.0

    Measured: Up to 5 years

Secondary outcomes (8)

  1. Investigator-assessed complete response (CR)

    Proportion of subjects who achieve a complete response (CR) per Lugano 2014 classification

    Measured: Up to 2 years

  2. Investigator-assessed objective-response rate (ORR)

    Proportion of subjects who achieve a partial response (PR) or complete response (CR) per Lugano 2014 classification

    Measured: Up to 2 years

  3. Investigator-assessed duration of response (DOR)

    Duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death from any cause, whichever occurs first, per Lugano 2014 classification

    Measured: Up to 15 years

  4. Investigator-assessed duration of complete response (DoCR)

    Duration from the first occurrence of a documented complete response (CR), per Lugano 2014 classification until the time of disease progression or relapse, or death from any cause, whichever occurs first

    Measured: Up to 15 years

  5. Progression-free survival (PFS)

    Time from first dose of study treatment to progressive disease (PD), or to the day of death for any reason, whichever occurs earlier, based on Lugano 2014 classification

    Measured: Up to 15 years

  6. Overall survival (OS)

    Time from first dose of study treatment to death from any cause

    Measured: Up to 15 years

  7. Area Under the Plasma Concentration Time Curve (AUC) of FT596

    Assessed by the detection of FT596 in peripheral blood following FT596 administration.

    Measured: Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8

  8. Maximum Plasma Concentration (Cmax) of FT596

    Assessed by the detection of FT596 in peripheral blood following FT596 administration.

    Measured: Cycles 1-6 (each cycle is 28 days): Days 1,8,11,15,18; and Post-Treatment Week 1, Week 2, Week 4, and Week 8

Timeline

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

  1. First posted6 Jul 2023
  2. Study startDec 2022 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2039 (estimated)

Why it stopped: This study was withdrawn (Sponsor decision).

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
Parallel groups
Model description
Subjects will be assigned to one of 2 treatment regimens corresponding to different schedules (standard or alternate) of R-CHOP
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05934097
Sponsor's protocol ID
FT596-102
Status last verified
Jun 2023
First submitted
30 Apr 2023
Last updated
6 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FT596, Cyclophosphamide and Doxorubicin in people with Diffuse Large B Cell Lymphoma and Transformed Indolent Non-Hodgkin's Lymphoma, run by Fate Therapeutics.

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 10 inclusion and 13 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: withdrawn, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Incidence of dose-limiting toxicities within each dose escalation cohort (time frame: Day 21). The study lists 3 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 NCT05934097.

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 6 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in