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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.

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I have been diagnosed with Large B-cell Lymphoma or Follicular Lymphoma.

ALPHA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 33 days

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

~1100

Cyclophosphamide

1995

Completed Phase 3

~3780

0 / 5Eligibility criteria met

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

Frequently Asked Questions

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

In what scenarios is ALLO-501 prescribed?

"ALLO-501 is frequently taken to treat multiple sclerosis and other diseases, such as mixed-cell type lymphoma, leukemia, myelocytic acute anemia, and retinoblastoma."

Answered by AI

Is there still space available for prospective participants in this investigation?

"The clinical trial is not presently enrolling participants. It was posted on 5/1/2019 and has been recently updated on 5/25/2022. If you are seeking another medical study, there are 1,741 trials for relapsed or refractory large b-cell lymphoma that accept patients as well as 889 studies involving ALLO-501 in need of volunteers."

Answered by AI

What is the upper limit of participants in this trial?

"Unfortunately, this research is no longer seeking participants at the moment. The study was initially posted on May 1st 2019 and last updated on 25th of May 2022. However, if you are interested in other trials related to relapsed/refractory large b cell lymphoma, there are presently 1741 studies that have open enrollment requirements; 889 for ALLO-501 as well."

Answered by AI

What potential harms do patients run the risk of by taking ALLO-501?

"Due to the limited amount of data available on ALLO-501, our team at Power has rated its safety a 1 on the scale. This is in keeping with it being an early Phase 1 trial."

Answered by AI

Have any previous experiments been conducted with ALLO-501?

"ALLO-501 was initially tested at the City of Hope Comprehensive Cancer Centre in 1997 and is now the subject of 1275 completed trials. A multitude of studies are currently ongoing, with a significant portion being conducted out of Louisville, Kentucky."

Answered by AI

Is the research project being conducted in multiple medical facilities across North America?

"As of now, 8 medical centres are taking part in the recruitment process for this trial. This includes Norton Cancer Institute (Louisville), Moffitt Cancer Center (Tampa) and Banner MD Anderson Cancer Centre (Gilbert). Additionally, there are 5 other sites participating as well."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

2019. "Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03939026.

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