← Back to Search

CAR T-cell Therapy

CAR T-cell Therapy for B-Cell Cancer

Q: Who is eligible to partake in this clinical experiment?

<p>This clinical trial is recruiting 80 <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, B-cell patients aged 18 to 75. To be eligible for the study, applicants must have either a lack of GVHD evidence or minimal clinical proof of acute and chronic GVHD while being off systemic immunosuppressive therapy for at least four weeks. Minimal acute GVHD should fall between grades 0 through I while minimal chronic GVHD has no organ site with a score greater than 1 (excluding skin which can have scores up to 2) according to the NIH consensus project from 2005. Additionally, participants need an ECOG performance status under 2 and 28 days ought to pass</p>

Phase 1

Waitlist Available

Led By James N Kochenderfer, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients with any CD19+ B-cell malignancy that is persistent or relapsed after all of the following interventions are eligible: Donor T cell engraftment after alloHSCT (>50% donor chimerism of the T cell compartment and a peripheral blood T cell number from the NIH, CC clinical lab of at least 50 CD3+ cells/uL) and a trial of withdrawal of immunosuppressive therapy.

At least 28 days weeks must have elapsed since the latest trial of withdraw of immunosuppression or DLI until the patient can be deemed to have persistent disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-5 weeks after first dose

Awards & highlights

Study Summary

This trial is testing a new way to treat cancer in people who have had a stem cell transplant but whose cancer has returned. Doctors will give them a new kind of genetically engineered T cell that specifically recognizes cancerous cells in order to attack them.

Who is the study for?

Adults aged 18-75 with B-cell malignancies that have persisted or returned after an allogeneic stem cell transplant are eligible. They must have received cells from a matched donor who is willing to donate again, and show CD19+ on cancer cells. Participants should not be pregnant, must consent to use contraception, and cannot have severe organ dysfunction or active infections.Check my eligibility

What is being tested?

The trial tests genetically engineered T-cells (anti-CD19-CAR-transduced) from the original donors against B-cell cancers unresponsive to prior treatments. It involves dose escalation of these T-cells, hospitalization post-infusion for monitoring, and long-term follow-up for up to 15 years.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to infused T-cells targeting cancerous cells which could affect normal tissues as well. Specific side effects will be monitored closely during the hospital stay following infusion and subsequent clinic visits.

Eligibility Criteria

Inclusion Criteria

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

Select...

My B-cell cancer has returned despite having a stem cell transplant and stopping immune-suppressing drugs.

Select...

It has been over 28 days since my last immune system treatment.

Select...

I stopped my antibody or chemotherapy 7 days before my T cell infusion and my side effects are mild.

Select...

My cancer cells show CD19 presence confirmed by specific tests.

Select...

I have little to no graft-versus-host disease and haven't taken immunosuppressants for 28 days.

Select...

I am the original donor for the patient's stem cell transplant and I am 18 or older.

Select...

My cancer cells mostly show CD19 presence.

Select...

I am between 18 and 75 years old.

Select...

I had a specific stem cell transplant for my B-cell cancer.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

My donor's T cells have successfully engrafted after my transplant.

Select...

I have ALL, Burkitt lymphoma, high-grade lymphomas similar to ALL, or diffuse large B-cell lymphoma and haven't had prior DLI.

Select...

I am undergoing or have completed a process to stop my immunosuppressive medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until the patient goes off-study for malignancy response assessment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until the patient goes off-study for malignancy response assessment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and until the patient goes off-study for malignancy response assessment. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

To assess the safety of allogeneic anti-CD19 CAR

Secondary outcome measures

To determine if administering anti-CD19-CAR-transduced T cells from the original transplant donor can cause regression of B-cell malignancies that are relapsed or persistent after alloHSCT

To measure the persistence of anti-CD19-CAR- transduced T cells in the blood of patients after infusion

Trial Design

3Treatment groups

Experimental Treatment

Group I: 2/Donor armExperimental Treatment1 Intervention

Leukapheresis

Group II: 1B/T memory stem cell armExperimental Treatment2 Interventions

Dose Escalation with 5 dose levels of CAR+ T memory cells based on the patients actual body-weight

Group III: 1A/T cell Arm (closed)Experimental Treatment2 Interventions

Dose escalation of CAR+ T cells based on the patients actual body-weight

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic stem cell transplant

2005

Completed Phase 2

~180

Leukapheresis

2010

Completed Phase 2

~640

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,638 Previous Clinical Trials

40,929,734 Total Patients Enrolled

James N Kochenderfer, M.D.Principal InvestigatorNational Cancer Institute (NCI)

8 Previous Clinical Trials

1,191 Total Patients Enrolled

Media Library

Anti-CD19-chimeric-antigen-receptor-transduced T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01087294 — Phase 1

B-Cell Lymphoma Research Study Groups: 2/Donor arm, 1B/T memory stem cell arm, 1A/T cell Arm (closed)

B-Cell Lymphoma Clinical Trial 2023: Anti-CD19-chimeric-antigen-receptor-transduced T cells Highlights & Side Effects. Trial Name: NCT01087294 — Phase 1

Anti-CD19-chimeric-antigen-receptor-transduced T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01087294 — Phase 1

Frequently Asked Questions

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

Is there any opportunity for new participants to join this research?

"This investigation, which was initially made available on 8/4/2010 and recently updated 11/16/2022, is not currently admitting new participants. Nevertheless, there are still 1,785 other trials actively recruiting patients at this time."

Answered by AI

What is the current regulatory status of Allogeneic stem cell transplantation?

"Although there is limited clinical evidence to support Allogeneic stem cell transplant's efficacy and safety, it still managed a rating of 1."

Answered by AI

Who is eligible to partake in this clinical experiment?

"This clinical trial is recruiting 80 lymphoma, B-cell patients aged 18 to 75. To be eligible for the study, applicants must have either a lack of GVHD evidence or minimal clinical proof of acute and chronic GVHD while being off systemic immunosuppressive therapy for at least four weeks. Minimal acute GVHD should fall between grades 0 through I while minimal chronic GVHD has no organ site with a score greater than 1 (excluding skin which can have scores up to 2) according to the NIH consensus project from 2005. Additionally, participants need an ECOG performance status under 2 and 28 days ought to pass"

Answered by AI