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CAR T-cell Therapy

Gene-Modified T Cells for Acute Lymphoblastic Leukemia

Q: What safety concerns should be taken into consideration when using gene-altered T cells for patient care?

<p>Due to scarce data regarding the safety and efficacy of gene-modified T cells, our team at Power rated their risk as a 1 on an ascending scale from 1-3.</p>

Q: Are additional volunteers being accepted into the trial at this time?

<p>According to clinicaltrials.gov, the advertised trial is not actively seeking participants at this time. It was first posted on May 1st 2010 and last updated February 1st 2022--however, there are currently 1498 other medical studies that are soliciting enrolments.</p>

Phase 1

Waitlist Available

Led By Jae Park, 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

Relapsed B-ALL and refractory patients are defined

Adult patients are eligible (> or = to 18 year old)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing an experimental treatment for leukemia that involves modifying immune cells called "T cells" to help them fight the cancer.

Who is the study for?

Adults over 18 with B-ALL leukemia that's resistant, relapsed, or in first complete remission can join. They need good heart and lung function, manageable blood chemistry levels, and a life expectancy over 3 months. Not allowed are those with recent heart attacks, severe heart failure, active GVHD from prior transplants, HIV/Hepatitis infections, active brain leukemia or other cancers needing treatment.Check my eligibility

What is being tested?

The trial tests T cells genetically modified to target CD19 on leukemia cells after being reinfused into the patient. The study aims to find the safe dose of these T cells post chemotherapy which is given to reduce leukemia and help T cells last longer.See study design

What are the potential side effects?

Potential side effects may include immune reactions due to modified T-cells attacking normal tissues (autoimmunity), symptoms related to infusion like fever or chills, and typical chemotherapy-related issues such as nausea, fatigue or increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My B-ALL cancer has returned or is not responding to treatment.

Select...

I am 18 years old or older.

Select...

I have been diagnosed with B-ALL.

Select...

My leukemia cells test positive for CD19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL.

Secondary outcome measures

To assess the anti-leukemic effect of adoptively transferred anti-CD19 T cells.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pts with B Cell Acute Lymphoblastic LeukemiaExperimental Treatment1 Intervention

This is a phase I study. Patients with CD19+ ALL (CR, relapsed, MRD, or refractory) are eligible for enrollment. B-ALL patients in first CR will be enrolled but only treated if they develop MRD or a frank relapse, while patients with MRD or with documented relapsed/refractory disease are eligible for immediate treatment. The T cell doses originally proposed in this study were based on doses administered safely in prior autologous T cell adoptive therapy trials but the dose has been modified based on the toxicities observed in patients with morphologic evidence of disease. Patients will be treated with different doses of T cells depending on the amount of disease at the time of T cell infusion. Patients in Cohort 1 (<5% blasts in the BM) will continue to receive 10^6 19-28z+ T cells/kg as previously. Patients in Cohort 2 (≥5% blasts in the BM) will receive the reduced dose of 1x106 19-28z+ T cells/kg).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,527 Total Patients Enrolled

116 Trials studying Leukemia

9,249 Patients Enrolled for Leukemia

Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

14 Previous Clinical Trials

392 Total Patients Enrolled

10 Trials studying Leukemia

231 Patients Enrolled for Leukemia

Media Library

Gene-modified T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01044069 — Phase 1

Leukemia Research Study Groups: Pts with B Cell Acute Lymphoblastic Leukemia

Leukemia Clinical Trial 2023: Gene-modified T cells Highlights & Side Effects. Trial Name: NCT01044069 — Phase 1

Gene-modified T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01044069 — Phase 1

Frequently Asked Questions

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

What safety concerns should be taken into consideration when using gene-altered T cells for patient care?

"Due to scarce data regarding the safety and efficacy of gene-modified T cells, our team at Power rated their risk as a 1 on an ascending scale from 1-3."

Answered by AI

Are additional volunteers being accepted into the trial at this time?

"According to clinicaltrials.gov, the advertised trial is not actively seeking participants at this time. It was first posted on May 1st 2010 and last updated February 1st 2022--however, there are currently 1498 other medical studies that are soliciting enrolments."

Answered by AI

Recent research and studies

Blood AdvancesJournal

Hematopoietic Recovery in Patients Receiving Chimeric Antigen Receptor T-cell Therapy for Hematologic Malignancies

Jain, Tania, Andrea Knezevic, Martina Pennisi, Yunxin Chen, Josel D. Ruiz, Terence J. Purdon, Sean M. Devlin, et al.. 2020. “Hematopoietic Recovery in Patients Receiving Chimeric Antigen Receptor T-cell Therapy for Hematologic Malignancies”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020002509.

Blood AdvancesJournal

Comparing CAR T-cell Toxicity Grading Systems: Application of the ASTCT Grading System and Implications for Management

Pennisi, Martina, Tania Jain, Bianca D. Santomasso, Elena Mead, Kitsada Wudhikarn, Mari Lynne Silverberg, Yakup Batlevi, et al.. 2020. “Comparing CAR T-cell Toxicity Grading Systems: Application of the ASTCT Grading System and Implications for Management”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2019000952.

Clinical Infectious DiseasesJournal

Cytokine Release Syndrome Grade as a Predictive Marker for Infections in Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Treated with Chimeric Antigen Receptor T Cells

Park, Jae H, F Andres Romero, Ying Taur, Michel Sadelain, Renier J Brentjens, Tobias M Hohl, and Susan K Seo. 2018. “Cytokine Release Syndrome Grade as a Predictive Marker for Infections in Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia Treated with Chimeric Antigen Receptor T Cells”. Clinical Infectious Diseases. Oxford University Press (OUP). doi:10.1093/cid/ciy152.

New England Journal of MedicineJournal