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CAR T-cell Therapy

Cema-cel for B-Cell Lymphoma (ALPHA3 Trial)

Phase 2
Recruiting
Research Sponsored by Allogene Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjusted EPOCH-R, Pola-R-CHP) as intended. Participants cannot have received additional lines of therapy
Participant achieved CR, or PR suitable for observation at the end of first line therapy based on PET/CT evaluation
Must not have
Active and clinically significant autoimmune disease
LBCL with history of central nervous system involvement, transformed from other malignancy (e.g., transformed follicular lymphoma or marginal zone lymphoma, Richter's transformation), or T-cell/histiocyte rich LBCL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Summary

This trial aims to assess the effectiveness and safety of using cemacabtagene ansegedleucel (cema-cel), a type of immunotherapy, in adult patients with large

Who is the study for?
This trial is for adults with large B-cell lymphoma (LBCL) who've had a complete or partial response to first-line therapy but still have minimal residual disease (MRD). They must be suitable for observation and have MRD detected by the Foresight CLARITY™ IUO MRD test.
What is being tested?
The study tests cemacabtagene ansegedleucel (cema-cel), a CD19 CAR T cell therapy, after standard chemo drugs fludarabine and cyclophosphamide, with or without ALLO-647. It compares this treatment's effectiveness and safety against just observing patients.
What are the potential side effects?
Possible side effects include reactions from the infusion of cema-cel, such as fever, fatigue, immune system complications, and potential toxicity from chemotherapy like nausea or low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I completed my first round of standard cancer treatment without starting another.
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My cancer responded well to the first treatment, as shown by PET/CT scans.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lymphoma diagnosis matches one of the types listed by WHO 2017.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an active and serious autoimmune disease.
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My large B-cell lymphoma has affected my brain or spinal cord, or it has changed from another type of cancer.
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I have been treated with anti-CD19 therapies before.
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I do not have any active infections needing treatment.
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I haven't had another cancer or bone marrow disorder in the last 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647
Incidence and severity of laboratory toxicities related to cemacabtagene ansegedleucel and ALLO-647

Trial Design

3Treatment groups
Experimental Treatment
Group I: cemacabtagene ansegedleucel, ALLO-647Experimental Treatment5 Interventions
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine, cyclophosphamide, and ALLO-647.
Group II: cemacabtagene ansegedleucelExperimental Treatment4 Interventions
Participants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
Group III: ObservationExperimental Treatment1 Intervention
Participants do not receive any study treatments. They are observed as per the current standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 4
~1860
Cyclophosphamide
2010
Completed Phase 4
~2320

Find a Location

Who is running the clinical trial?

Allogene TherapeuticsLead Sponsor
6 Previous Clinical Trials
562 Total Patients Enrolled
Foresight Diagnostics, Inc.UNKNOWN
Allogene Study DirectorStudy DirectorAllogene Therapeutics, Inc.
~167 spots leftby Aug 2027
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