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CAR T-cell Therapy

CAR T-cell Therapy for Lymphoma and Leukemia

Q: Are participants being recruited for this research endeavor at present?

Affirmative. According to clinicaltrials.gov, this medical experiment is currently recruiting participants; it was initially announced on June 30th 2022 and its latest amendment happened on November 4th 2022. 36 test subjects are being recruited from a single site for the study.

Q: What is the current size of participation in this clinical experiment?

Correct. The information on clinicaltrials.gov confirms that this medical trial, which was first posted on June 30th 2022, is actively searching for participants. This study demands a total of 36 patients from one distinct location to take part in the research endeavour.

Q: Has the FDA rendered an opinion on Anti-CD19/CD20/CD22 CAR T-Cells?

Antibody-dependent cellular toxicity of Anti-CD19/CD20/CD22 CAR T-Cells is classified as a 1 due to the limited data regarding safety and efficacy, which are both being tested in this Phase 1 trial.

Phase 1

Recruiting

Led By Sumithira Vasu, MD

Research Sponsored by Sumithira Vasu

Eligibility Criteria Checklist

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

Must have

Subjects with refractory high-grade B-cell lymphoma relapsing within 12 months of autologous stem cell transplant

Patients with CD19 and/or CD20 and/or CD22 positive lymphoid malignancy, who received blinatumomab or inotuzumab, aged >= 18 years, with ECOG performance status =< 2, adequate organ function, and ability to understand and sign informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 years

Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving genetically modified cells. The treatment is designed to target and kill cancer cells, with the hope of providing a more effective treatment for patients with lymphoid cancers.

Who is the study for?

Adults with certain relapsed or refractory lymphoid cancers, including non-Hodgkin lymphoma and various types of leukemia. Participants must have tried at least two prior therapies, have a minimum level of white blood cells, good heart and lung function, and agree to use highly effective contraception. Excluded are those with recent transplants, active infections or other malignancies that could affect the trial's safety.Check my eligibility

What is being tested?

The trial is testing genetically engineered CAR T-cells targeting CD19/CD20/CD22 on cancer cells following chemotherapy (cyclophosphamide and fludarabine). It aims to determine the safest dose for infusion of these modified T-cells in patients whose cancers haven't responded well to previous treatments.See study design

What are the potential side effects?

Potential side effects include immune system reactions leading to inflammation in different body parts, symptoms related to infusion such as fever or chills, fatigue, possible organ dysfunction due to targeted cell destruction by CAR T-cells, and increased risk of infection from pre-infusion chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My high-grade B-cell lymphoma came back within a year after my stem cell transplant.

Select...

I am 18 or older with a specific type of blood cancer, have received certain treatments, can move around, and understand the consent form.

Select...

I have CLL and have been treated with at least 2 therapies including a BTK inhibitor and venetoclax.

Select...

I have acute B-lymphoblastic leukemia that has not responded to at least 2 treatments or I cannot undergo a stem cell transplant.

Select...

I have lymphoma or leukemia that has not improved after at least two treatments.

Select...

I agree to not have unprotected sex or donate sperm.

Select...

I have B-prolymphocytic leukemia that didn't respond to 1-2 treatments and can't have a stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Recommended phase II dose of anti-CD19/CD20/CD22 CAR-T cells for each study group (Cohort A and Cohort B)

Secondary outcome measures

Complete response rate

Incidence of adverse events

Overall response rate

+2 more

Other outcome measures

Correlation between CD19/20/22 expression on disease response

Correlation between cytokine serum concentrations and disease response

Presence of measurable CAR-T cells

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B (lymphodepletion, anti-CD19/CD20/CD22 CAR-T cells)Experimental Treatment3 Interventions

LYMPHODEPLETIVE REGIMEN: Patients receive cyclophosphamide IV over 60 minutes on day -6 and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. CAR T-CELL THERAPY: Patients receive anti-CD19/CD20/CD22 CAR-T cells IV over 5-30 minutes on day 0 and 7.

Group II: Cohort A (lymphodepletion; anti-CD19/CD20/CD22 CAR-T cells)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine Phosphate

1997

Completed Phase 3

~2390

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sumithira VasuLead Sponsor

5 Previous Clinical Trials

86 Total Patients Enrolled

Sumithira Vasu, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

2 Previous Clinical Trials

33 Total Patients Enrolled

Media Library

Anti-CD19/CD20/CD22 CAR T-Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05418088 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: Cohort A (lymphodepletion; anti-CD19/CD20/CD22 CAR-T cells), Cohort B (lymphodepletion, anti-CD19/CD20/CD22 CAR-T cells)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Anti-CD19/CD20/CD22 CAR T-Cells Highlights & Side Effects. Trial Name: NCT05418088 — Phase 1

Anti-CD19/CD20/CD22 CAR T-Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05418088 — Phase 1

Frequently Asked Questions

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

Are participants being recruited for this research endeavor at present?

"Affirmative. According to clinicaltrials.gov, this medical experiment is currently recruiting participants; it was initially announced on June 30th 2022 and its latest amendment happened on November 4th 2022. 36 test subjects are being recruited from a single site for the study."

Answered by AI

What is the current size of participation in this clinical experiment?

"Correct. The information on clinicaltrials.gov confirms that this medical trial, which was first posted on June 30th 2022, is actively searching for participants. This study demands a total of 36 patients from one distinct location to take part in the research endeavour."

Answered by AI

Has the FDA rendered an opinion on Anti-CD19/CD20/CD22 CAR T-Cells?

"Antibody-dependent cellular toxicity of Anti-CD19/CD20/CD22 CAR T-Cells is classified as a 1 due to the limited data regarding safety and efficacy, which are both being tested in this Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies

Sumithira Vasu 2022. "Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05418088.