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CancerPhase 2FIRCE-1NCT05972720

A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma

A Phase 2 study testing Fludarabine (Conditional therapy), Cyclophosphamide Monohydrate (Conditional therapy) and firi-cel (Experimental drug) in people with Cancer and Relapsed/Refractory Large B-cell Lymphoma (LBCL), run by CARGO Therapeutics at 31 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fludarabine (Conditional therapy), Cyclophosphamide Monohydrate (Conditional therapy) and firi-cel (Experimental drug)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
31 sitesUnited States
Study dates
1 Aug 2023to 4 Apr 2025
Phase
Phase 2
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

  • Aged ≥18 years
  • Relapsed or refractory, histologically confirmed large B-cell lymphoma.
  • Must have relapsed or refractory diseae after last therapy.
  • For enrollment in cohort 1, patients must have previously received a CD19-directed CAR T-cell therapy
  • For enrollment in cohort 3, patients must have received at least two prior lines of therapy including a bispecific T-cel engaging antibody therapy.
  • Must have at least one radiographically measurable lesion.
Show all 9Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate hematological, renal, and liver function
  • Willing and able to remain within 1 hour of the treating center for at least 4 weeks after infusion.

Who cannot join

  • Clinically significant concurrent medical illness
  • Active fungal, bacterial, viral or other infection.
  • Prior allogeneic stem cell transplant or allogeneic cell therapy
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • Northside Hospital

    Atlanta, Georgia, 30342

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • National Cancer Institute

    Bethesda, Maryland, 20892

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390-9020

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • City of Hope National Medical Center

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hopitals & Clinics

    Iowa City, Iowa, 52242

  • University of Arkansas Medical Sciences

    Little Rock, Arkansas, 72205

  • UCLA Division of Hematology Oncology

    Los Angeles, California, 90095

  • University of Miami Hospital Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226-1222

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06511

  • New York University Medical Center

    New York, New York, 10016

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Swedish Medical Center

    Seattle, Washington, 98104

  • UW-Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Stanford University Hospital and Clinics

    Stanford, California, 94305

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-941

  • University of Kansas Medical Center Research Institute, Inc

    Westwood, Kansas, 66205

Other trials in United States

About this study

Official title: An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of Firi-cel, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy

This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).

Read the detailed description

Firicabtagene autoleucel (firi-cel) is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of firi-cel in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of firi-cel.

Being tested
Fludarabine (Conditional therapy), Cyclophosphamide Monohydrate (Conditional therapy), firi-cel (Experimental drug)
Keywords
Lymphoma, CD-22 Expressing Tumor, Chimeric Antigen Receptor, Adoptive Immunotherapy, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Primary Mediastinal B-cell, Lymphoma, Transformed, Lymphoma, Transformed Non-Hodgkin, Lymphoma, Non-Hodgkin, CAR T, CAR T-cell therapy, Cell Therapy, Cellular Immuno-therapy, CRG-022, CD22, FIRCE-1, firicabtagene autoleucel, firi-cel
Medical subject headings
Neoplasms, Recurrence, Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

What participants receive

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

  • Fludarabine (Conditional therapy)Drug

    Lymphodepletion chemotherapy

  • Cyclophosphamide Monohydrate (Conditional therapy)Drug

    Lymphodepletion chemotherapy

  • firi-cel (Experimental drug)Drug

    Investigational agent

Study groups in NCT05972720
Study groupRoleWhat they receive
Experimental Drug (Cohort 1)ExperimentalSingle infusion of firi-cel following conditioning chemotherapy
Receives: Drug: Fludarabine (Conditional therapy); Drug: Cyclophosphamide Monohydrate (Conditional therapy); Drug: firi-cel (Experimental drug)
Experimental Drug (Cohort 2: non-conforming product)ExperimentalSingle infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer).
Receives: Drug: Fludarabine (Conditional therapy); Drug: Cyclophosphamide Monohydrate (Conditional therapy); Drug: firi-cel (Experimental drug)
Experimental Drug (Cohort 3)ExperimentalPatients with relapsed or refractory Large B-cell lymphoma who have previously been treated with bispecific T-cell engaging antibody therapy will receive a single infusion of firi-cel following conditioning chemotherapy.
Receives: Drug: Fludarabine (Conditional therapy); Drug: Cyclophosphamide Monohydrate (Conditional therapy); Drug: firi-cel (Experimental drug)

What is being measured

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

  1. Objective response rate - Blinded independent review

    Percentage of patients with complete or partial response determined by a blinded independent review committee

    Measured: Up to 24 months

Secondary outcomes (7)

  1. Objective response rate - Investigator assessment

    Percentage of patients with complete or partial response determined by the investigator

    Measured: Up to 24-months

  2. Complete response rate

    Percentage of patients who achieve a Complete Response determined by independent review committee and investigators assessment

    Measured: Up to 24-months

  3. Duration of response

    Duration of response (the time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause) determined by independent review committee and investigators

    Measured: Up to 24-months

  4. Duration of complete response

    Time from the date of the first occurrence of CR to the date of progression, relapse, or death from any cause determined by independent review committee and investigators.

    Measured: Up to 24-months

  5. Progression-free survival

    Progression-free survival (the time from CRG-022 infusion until the first occurrence of disease progression or relapse) determined by independent review committee and investigator assessment

    Measured: Up to 24-months

  6. Overall Survival

    Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the Investigator.

    Measured: Up to 24-months

  7. Incidence rate of adverse events

    Percentage of patients with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.

    Measured: From Screening up to 15 years at protocol-defined timepoints

Timeline

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

  1. First posted2 Aug 2023
  2. Study start1 Aug 2023
  3. Primary completion4 Apr 2025
  4. Study completion4 Apr 2025

Why it stopped: Company decision to stop trial, withdraw the IND and close down operations.

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05972720
Sponsor's protocol ID
CRG-022-101
Acronym
FIRCE-1
Status last verified
May 2025
First submitted
25 Jul 2023
Last updated
15 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fludarabine (Conditional therapy), Cyclophosphamide Monohydrate (Conditional therapy) and firi-cel (Experimental drug) in people with Cancer and Relapsed/Refractory Large B-cell Lymphoma (LBCL), run by CARGO Therapeutics at 31 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 9 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 stopped early (reason given: Company decision to stop trial, withdraw the IND and close down operations.). Results are not available in the source record.

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?

Objective response rate - Blinded independent review (time frame: Up to 24 months). 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 NCT05972720.

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 15 May 2025.

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