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CAR T-cell Therapy

CRG-022 for Large B-Cell Lymphoma

Phase 2

Recruiting

Research Sponsored by CARGO Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening up to 15 years at protocol-defined timepoints

Awards & highlights

Study Summary

This trial is testing a new therapy for lymphoma that looks at safety, effectiveness, how the body responds, and how well it works.

Who is the study for?

This trial is for adults over 18 with Large B-cell Lymphoma that's come back or hasn't responded to treatment. They must have a certain level of neutrophils, a type of white blood cell, and be well enough for daily activities (ECOG status 0-1). Some need to have tried specific previous therapies like CD19-directed CAR T-cell therapy or bispecific T-cell engaging antibodies.Check my eligibility

What is being tested?

The study tests CRG-022, an experimental CAR T-cell therapy targeting CD22 in the body. It's given alongside Fludarabine and Cyclophosphamide Monohydrate as conditional treatments. The goal is to see how safe it is, how the body reacts to it, and if it works against relapsed/refractory large B-cell lymphoma.See study design

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal cells while targeting cancer cells (like fever or fatigue), issues from where the infusion enters the body, and effects on blood counts which can increase infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening up to 15 years at protocol-defined timepoints

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening up to 15 years at protocol-defined timepoints

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening up to 15 years at protocol-defined timepoints for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate - Blinded independent review

Secondary outcome measures

Complete response rate

Duration of complete response

Duration of response

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental DrugExperimental Treatment3 Interventions

Single infusion of CRG-022 following conditioning chemotherapy

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

CARGO TherapeuticsLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographic scope of this experiment?

"Patients can get enrolled in this clinical trial at Stanford University Hospital and Clinics, Colorado Blood Cancer Institute, Dana-Farber Cancer Institute and other 6 sites."

Answered by AI

How many participants are engaging in this research?

"This clinical trial is being spearheaded by CARGO Therapeutics and requires 123 participants that adhere to the eligibility requirements. These individuals will be recruited from a variety of sites, including Stanford University Hospital and Clinics in Stanford, Colorado and Colorado Blood Cancer Institute in Denver, Massachusetts."

Answered by AI

Has the Experimental Drug secured permission from the FDA for public use?

"The safety of Experimental Drug was assessed as a 2, since there is evidence that it does not pose any harm to the user, but no trials have been conducted yet to show its efficacy."

Answered by AI

Is enrollment for this research project currently available to those seeking treatment?

"Affirmative. Clinicaltrials.gov reveals that this clinical investigation, which was first published on August 1st 2023, is actively recruiting patients. The project requires 123 participants to be enrolled from 6 distinct medical establishments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Study of CRG-022 in Patients With Relapsed/Refractory Large B-cell Lymphoma

2023. "A Phase 2 Study of CRG-022 in Patients With Relapsed/Refractory Large B-cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972720.