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CAR T-cell Therapy

ALLO-501 CAR T Cells for Lymphoma (ALPHA Trial)

Phase 1
Waitlist Available
Research Sponsored by Allogene Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapse or refractory disease after at least 2 lines of chemotherapy
Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 33 days
Awards & highlights

ALPHA Trial Summary

This trial is testing a new treatment for people with lymphoma who haven't responded to other treatments.

Who is the study for?
Adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma can join this trial. They must have tried at least two chemotherapy treatments, have one measurable lesion, be in good physical condition (ECOG score of 0 or 1), and their major organs need to function well. People with CNS lymphoma, recent stem cell transplants, prior CD19 therapy, ongoing immunosuppressants, active GvHD, severe immunodeficiency disorders or uncontrolled thyroid disease cannot participate.Check my eligibility
What is being tested?
The ALPHA study is testing the safety and effectiveness of ALLO-501 Anti-CD19 Allogeneic CAR T Cells after a preparatory treatment with fludarabine, cyclophosphamide, and ALLO-647. The goal is to see how these cells work as a treatment for certain types of lymphoma that haven't responded to other therapies.See study design
What are the potential side effects?
Possible side effects include reactions related to the infusion process itself such as fever and chills; low blood counts leading to increased risk of infection; fatigue; liver dysfunction; neurological events like confusion or seizures; and potential immune system complications.

ALPHA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition did not improve after two chemotherapy treatments.
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I have been diagnosed with Large B-cell Lymphoma or Follicular Lymphoma.
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I am fully active or can carry out light work.
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I am fully active or can carry out light work.
Select...
I have been diagnosed with Large B-cell Lymphoma or Follicular Lymphoma.

ALPHA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~33 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501

ALPHA Trial Design

1Treatment groups
Experimental Treatment
Group I: ALLO-647, ALLO-501Experimental Treatment4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1080
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Allogene TherapeuticsLead Sponsor
5 Previous Clinical Trials
618 Total Patients Enrolled

Media Library

ALLO-501 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03939026 — Phase 1
Follicular Lymphoma Research Study Groups: ALLO-647, ALLO-501
Follicular Lymphoma Clinical Trial 2023: ALLO-501 Highlights & Side Effects. Trial Name: NCT03939026 — Phase 1
ALLO-501 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03939026 — Phase 1
~12 spots leftby Jun 2025
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