93 Participants Needed

Gene-Modified T Cells for Acute Lymphoblastic Leukemia

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is an investigational approach that uses immune cells, called "T cells", to kill leukemia. These T cells are removed from blood, modified in a laboratory, and then put back in the body. T cells fight infections and can also kill cancer cells in some cases. However, right now T cells are unable to kill the cancer cells. For this reason we will put one gene into the T cells that allows them to recognize and kill the leukemia cells. This gene will be put in the T cells by a weakened virus. The gene will produce proteins in the T cells that help the T cells recognize the leukemia cells and possibly kill them. The doctors have found that T cells modified in this way can cure an ALL-like cancer in mice.The main goals of this study is to determine the safety and appropriate dose of these modified T cells in patients with ALL. This will be done in a "clinical trial." The dose of modified T-cells will depend on if you have disease present in your bone marrow or not. The patient will also receive chemotherapy before the T cells. We will use normally chemotherapy that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to allow the T cells to live longer.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since chemotherapy is part of the treatment, it's best to discuss your current medications with the trial doctors to ensure there are no interactions.

Is gene-modified T cell therapy generally safe for humans?

Gene-modified T cell therapy, like CAR-T cell therapy, has shown promise in treating certain cancers, but it can cause serious side effects. Common side effects include cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage), though these are often mild. Long-term safety is still being studied, and more research is needed to fully understand the risks.12345

How does the treatment Gene-modified T cells differ from other treatments for acute lymphoblastic leukemia?

Gene-modified T cells, specifically CAR-T cell therapy, are unique because they involve genetically engineering a patient's own T cells to better recognize and attack leukemia cells. This approach is different from traditional treatments like chemotherapy and stem cell transplants, as it directly targets cancer cells with modified immune cells, offering a promising option for patients with relapsed or refractory acute lymphoblastic leukemia.15678

What data supports the effectiveness of the treatment Gene-modified T cells for Acute Lymphoblastic Leukemia?

Research shows that gene-modified T cells, specifically CAR T-cells, have been highly effective in treating acute lymphoblastic leukemia (ALL), with complete remission rates over 70% in trials. This treatment has become a key option for patients with relapsed or hard-to-treat ALL, offering new hope where traditional methods have failed.15679

Who Is on the Research Team?

JP

Jae Park, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My B-ALL cancer has returned or is not responding to treatment.
My B-cell ALL is not responding to treatment, has returned, or is in the first complete remission.
MRD is defined as residual disease measured by specific methods
See 4 more

Exclusion Criteria

My leukemia has spread to my brain or spinal cord recently.
I had a stem cell transplant from a donor and am experiencing complications.
I have HIV, hepatitis B, or hepatitis C.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive chemotherapy to reduce leukemia and allow T cells to live longer

2-3 weeks

T Cell Infusion

Participants receive genetically modified T cells to target leukemia cells

1 week

Follow-up

Participants are monitored for safety and effectiveness after T cell infusion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Gene-modified T cells
Trial Overview 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.
How Is the Trial Designed?
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Published Research Related to This Trial

CAR-T cell therapy targeting CD19 has been FDA-approved for treating relapsed and refractory acute lymphoblastic leukemia (ALL) in children and young adults, showing promising efficacy.
Recent trials with CD22-directed CAR-T cells indicate they can also effectively target leukemia, providing a potential alternative to CD19 therapy, although challenges like toxicity management and relapse rates remain.
CAR-T Cell Therapy for Acute Lymphoblastic Leukemia: Transforming the Treatment of Relapsed and Refractory Disease.Pehlivan, KC., Duncan, BB., Lee, DW.[2019]
CAR T-cell therapy has significantly improved treatment options for acute lymphoblastic leukemia (ALL), achieving over 70% complete remission rates in clinical trials, and has been FDA approved for use in relapsed/refractory cases.
Despite its effectiveness, challenges such as relapse, resistance, and loss of CAR T-cell persistence pose barriers to long-term remission, highlighting the need for advancements in CAR T-cell engineering to enhance treatment outcomes.
Improving CAR T-cells: The next generation.Marple, AH., Bonifant, CL., Shah, NN.[2021]
Adoptive transfer of antigen-specific T cells shows promise for treating viral infections in immunosuppressed patients, but achieving effective T-cell therapy for cancer is more challenging due to issues like T-cell tolerance and impaired survival in the body.
Genetic modification of T cells before transfer may help overcome obstacles such as tumor evasion tactics and improve the effectiveness of T-cell therapies for both cancer and infectious diseases.
Genetic modification of T cells for immunotherapy.Berger, C., Berger, M., Feng, J., et al.[2019]

Citations

CAR-T Cell Therapy for Acute Lymphoblastic Leukemia: Transforming the Treatment of Relapsed and Refractory Disease. [2019]
Antileukemia multifunctionality of CD4(+) T cells genetically engineered by HLA class I-restricted and WT1-specific T-cell receptor gene transfer. [2018]
Improving CAR T-cells: The next generation. [2021]
Redirecting T cells with Chimeric Antigen Receptor (CAR) for the treatment of childhood acute lymphoblastic leukemia. [2018]
Genetic modification of T cells for immunotherapy. [2019]
Adoptive immunotherapy utilizing cancer antigen-specific T-cell receptors. [2017]
Chimeric Antigen Receptor Based Cellular Therapy for Treatment Of T-Cell Malignancies. [2022]
Chimeric Antigen Receptor Therapy in Acute Lymphoblastic Leukemia Clinical Practice. [2018]
Genetic redirection of T cells for cancer therapy. [2010]
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