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CAR T-cell Therapy

Genetically Modified T cells for Leukemia and Lymphoma

Phase 1

Waitlist Available

Led By Kevin Curran, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Relapse on this protocol is detection of CD19+ malignancies in bone marrow morphology ≥ 5% any extramedullary lesion (radiographic), or detection of any disease level by cytogenetics, molecular, and/or flow cytometry

History of CD19+ relapse/refractory (R/R) B cell malignancies occurring after allogeneic/autologous HSCT or solid organ transplant (SOT) (cohort 1)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial is testing the safety of giving patients modified T-cells from a donor. The goal is to see if these cells cause any toxicities in patients with relapsed B cell leukemia or lymphoma.

Who is the study for?

This trial is for patients with B-cell leukemia or lymphoma who have had a stem cell transplant or are at high risk of relapse. They must have proper kidney, liver, heart, and lung function. It's not for those with active HIV/hepatitis infections, other cancers needing treatment, pregnant women, severe heart conditions, uncontrolled illnesses that could worsen side effects from the therapy.Check my eligibility

What is being tested?

The study tests the safety of Modified T-cells from donors targeting CD19 antigen in patients with relapsed B-cell malignancies post-transplant or at high risk of relapse. The focus is on assessing toxicities related to these genetically modified cells after chemotherapy conditioning.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response such as cytokine release syndrome (flu-like symptoms), neurological issues (headaches, confusion), and typical risks associated with chemotherapy like fatigue and increased infection susceptibility.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has returned and tests show more than 5% cancer cells in my bone marrow or any cancer presence detected by specific tests.

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My cancer returned after a stem cell or organ transplant.

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My liver tests are within the required limits.

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I can do most of my daily activities by myself.

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My kidney function is normal, with creatinine levels within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Evaluate the safety/persistence of (including GVHD) of allogeneic EBV specific CTL modified to express artificial T cell receptors targeting CD19 molecule given for persistence or relapse of B-Cell ALL post allogeneic HSCT.

Secondary outcome measures

To assess long-term status of treated patients

To assess the effects of the adoptively transferred CD19 specific T-cells on the progression of leukemia.

To quantitate the number of chimeric antigen receptor (CAR) positive T-cells and donor EBV-CTL in the blood at defined intervals post infusion in order to determine their survival and proliferation in the host.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Biological/Genetically Modified T cellsExperimental Treatment2 Interventions

Utilizing our initial trial experience, it was amended to include three (3) expansion cohorts. Cohort 1: patients with CD19+ relapse/refractory (R/R) B cell malignancies occurring after allogeneic/autologous HSCT or solid organ transplant (SOT) infusion occurring following conditioning chemotherapy. Cohort 2:patients with CD10+ high risk B cell malignancies eligible for autologous HSCT followed by 19-28z CRA EBV-CTLs (auto-HSCT preparative regimen serves as conditioning chemotherapy. Cohort 3: patients with CD19+ high risk B cell malignancies eligible for allogeneic HSCT followed by consolidative 19-28z CAR EBV-CTLs (allo-HSCT preparative regimen serves as conditioning chemotherapy) Each expansion cohort has a target accrual of 6 patients treated with fixed CAR EBV-CTL dose (3x106 EBV-CTLs/kg) which has been demonstrated to be the ideal manufacturing dose.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,601 Total Patients Enrolled

Kevin Curran, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

115 Total Patients Enrolled

Media Library

Modified T-cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01430390 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: Biological/Genetically Modified T cells

Modified T-cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01430390 — Phase 1

Frequently Asked Questions

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

What diseases have been addressed successfully through utilizing modified T cells?

"Biologically or genetically modified T cells can be highly effective at treating multiple sclerosis, as well as a plethora of other illnesses such leukemia, myelocytic acute lymphoblastic leukemia, mixed cell type lymphoma, and retinoblastoma."

Answered by AI

Are Biological/Genetically Modified T cells allowed by the FDA?

"Limited data on Biological/Genetically Modified T cells' effectiveness and safety resulted in a score of 1."

Answered by AI

Are there available slots in this clinical trial for participants?

"Based on the information from clinicaltrials.gov, this particular medical trial has now concluded its recruitment process. The study was posted in September 2011 and last updated in August 2022; nevertheless, there are still 2904 other studies actively looking for participants at present."

Answered by AI

What is the ceiling for participants in this medical experiment?

"At present, this trial is closed for recruitment. It was first advertised on September 1st 2011 and the last update occurred on August 31st 2022. Alternately, there are 2088 trials actively searching for lymphoma patients and 816 studies utilizing Biological/Genetically Modified T cells that are currently enrolling participants."

Answered by AI

Has research into Biological/Genetically Modified T cells been explored in the past?

"At present, 816 active studies related to Biological/Genetically Modified T cells are in the process of recruitment with 154 trials at Phase 3. Although most of these clinical trials occur within Philadelphia, Pennsylvania, 27827 locations across the United States have begun enrolling patients for research on Biological/Genetically Modified T cells."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-cell Malignancies

2011. "In Vitro Expanded Allogeneic Epstein-Barr Virus Specific Cytotoxic T-Lymphocytes (EBV-CTLs) Genetically Targeted to the CD19 Antigen in B-cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01430390.

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