CAR T Cell Therapy for Acute Lymphoblastic Leukemia

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with B-cell acute lymphoblastic leukemia, a type of blood cancer. The treatment modifies a person's immune cells in a lab to better target and attack cancer cells. Known as CAR T cell therapy, this approach uses Autologous Anti-CD19 CAR-expressing T Lymphocytes. The study aims to determine the safest dose and understand any side effects. It suits those aged 55 and older who have this specific leukemia and are currently in remission. Participants must have completed previous cancer treatments and have no immediate plans for a transplant.

As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using systemic steroids or chronic immunosuppressants. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that autologous anti-CD19 CAR T-cell therapy has been studied for safety and effectiveness. In earlier studies, these specially modified T cells showed promise in treating certain types of leukemia. Most patients handled the treatment well, though some experienced side effects.

Reports from past studies indicate that while some patients experience mild to moderate side effects, serious ones are less common. These side effects can include fever, tiredness, and low blood cell counts. The treatment works by modifying a patient's own T cells to better fight cancer, which can cause these reactions.

Since this trial is in the early stages, the main goal is to ensure the treatment's safety and determine the right dose. Safety evidence from previous studies, although limited, seems promising, especially since CAR T-cell therapies are already used for similar conditions.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for acute lymphoblastic leukemia, which often involve chemotherapy and radiation, CAR T Cell Therapy uses genetically engineered T cells to specifically target and destroy cancer cells. This treatment is unique because it involves reprogramming a patient's own immune cells to recognize and attack cells expressing the CD19 protein, commonly found on leukemia cells. Researchers are excited about this approach because it offers a targeted attack on cancer cells, potentially leading to fewer side effects and improved outcomes compared to traditional therapies. Plus, this therapy represents a personalized medicine approach, tailoring treatment to each individual's unique biology.

What evidence suggests that this treatment might be an effective treatment for acute lymphoblastic leukemia?

Research shows that autologous anti-CD19 CAR T-cell therapy, which participants in this trial will receive, could be promising for treating B-cell acute lymphoblastic leukemia. Studies have found that 70% to 90% of patients with relapsed leukemia achieved complete remission after receiving this therapy. Lab-created CAR T cells specifically target and destroy cancer cells, offering a personalized approach to fighting the disease. While this treatment has been effective, ongoing research aims to improve outcomes and manage potential side effects. Overall, this therapy represents a significant advancement in leukemia treatment.36789

Who Is on the Research Team?

Ibrahim T. Aldoss, M.D. | City of Hope

Ibrahim Aldoss, MD

Principal Investigator

City of Hope Medical Cancer Center

Are You a Good Fit for This Trial?

Adults aged 55 or older with B-cell acute lymphoblastic leukemia in first remission can join this trial. They must have a good performance status, proper liver and kidney function, and no severe infections like HIV or hepatitis. Women of childbearing age need a negative pregnancy test and agree to use birth control.

Inclusion Criteria

Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)
My cancer is in its first full remission.
Agreement to allow the use of archival tissue from diagnostic tumor biopsies. Exceptions may be granted with Study Principal Investigator (PI) approval
See 17 more

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent(s)
Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded
My brain or spinal cord cancer hasn't responded to specific treatments but is now in remission.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis and Pre-treatment

Patients undergo T cell leukapheresis and receive fludarabine and cyclophosphamide intravenously

1-2 weeks
Multiple visits for leukapheresis and chemotherapy administration

Treatment

Patients receive CD19-CAR T cell infusion intravenously

1 day
1 visit (in-person) for infusion

Follow-up

Participants are monitored for safety, effectiveness, and adverse events after treatment

28 days
Regular visits for monitoring adverse events and response

Long-term Follow-up

Participants are monitored for event-free survival, overall survival, and relapse

Up to 15 years

What Are the Treatments Tested in This Trial?

Interventions

  • Autologous Anti-CD19 CAR-expressing T Lymphocytes
Trial Overview The trial is testing the safety and optimal dose of modified T cells (CD19-CAR T cells) that are designed to target leukemia cells in older adults. It involves taking the patient's own immune cells, modifying them in a lab, growing large numbers, and infusing them back into the patient.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (CD19-CAR T cells)Experimental Treatment7 Interventions

Autologous Anti-CD19 CAR-expressing T Lymphocytes is already approved in United States, European Union for the following indications:

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Approved in United States as Tisagenlecleucel (Kymriah) for:
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Approved in European Union as Tisagenlecleucel (Kymriah) for:
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Approved in United States as Axicabtagene ciloleucel (Yescarta) for:
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Approved in European Union as Axicabtagene ciloleucel (Yescarta) for:
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Approved in United States as Lisocabtagene maraleucel (Breyanzi) for:
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Approved in European Union as Lisocabtagene maraleucel (Breyanzi) for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Adoptive cellular therapy using CD19 CAR T cells has shown remarkable efficacy in achieving remission in 67-90% of patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL), indicating a promising treatment option for this high-risk group.
While CD19 CAR T-cell therapy can lead to significant toxicities such as cytokine release syndrome and neurologic dysfunction, these effects are generally manageable with supportive care, highlighting the need for careful monitoring during treatment.
CD19-redirected chimeric antigen receptor-modified T cells: a promising immunotherapy for children and adults with B-cell acute lymphoblastic leukemia (ALL).Tasian, SK., Gardner, RA.[2020]
A 71-year-old woman with relapsed and refractory acute lymphoblastic leukemia (ALL) achieved undetectable minimal residual disease after receiving haplo-identical donor-derived CD19 CAR-T cells combined with mobilized peripheral blood stem cells, indicating potential efficacy in treating elderly patients.
While the treatment led to full donor cell engraftment, it also caused transient cytokine release and mild fever, along with reversible increases in liver enzymes, highlighting the need for caution regarding complications from donor cell infusions.
Co-infusion of haplo-identical CD19-chimeric antigen receptor T cells and stem cells achieved full donor engraftment in refractory acute lymphoblastic leukemia.Cai, B., Guo, M., Wang, Y., et al.[2018]
CD19/20/22 CAR T-cells have been developed to effectively target B-lineage acute lymphoblastic leukemia (BL-ALL) that has relapsed with CD19(-) disease, showing efficacy in both laboratory and animal models.
These CAR T-cells maintain their effectiveness against CD19(+) disease while also being able to kill CD19(-) blasts, suggesting they could serve as a new treatment option for patients who do not respond to traditional CD19-targeting therapies.
CAR T-cells that target acute B-lineage leukemia irrespective of CD19 expression.Fousek, K., Watanabe, J., Joseph, SK., et al.[2022]

Citations

Survival outcomes and efficacy of autologous CD19 ...Methods: We conducted a meta-analysis in 320 patients from 14 studies to estimate the survival outcome, response rate and toxicity of autologous CD19 CAR-T cell ...
Long-Term Follow-up of CD19 CAR Therapy in Acute ...Multiple clinical trials of CD19-specific CAR T cells have shown complete remission rates of 70 to 90% among children and adults with relapsed B ...
Study Details | NCT05707273 | CD19-Car T Cell Therapy ...This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults ...
A phase I study of allogeneic anti-CD19 CAR-T therapy for ...Background: Acute B-lymphoblastic leukemia (B-ALL), characterized by CD19 expression, responds well to CD19-targeted CAR-T therapy.
Long-term response to autologous anti-CD19 chimeric ...These findings suggest that CAR T cell therapy may offer long-term benefits to patients with R/R B-ALL. However, further research is needed to optimize patient ...
Study Details | NCT05707273 | CD19-Car T Cell Therapy ...This phase I trial tests the safety, side effects, and best dose of autologous anti-CD19 CAR-expressing T lymphocytes (CD19-CAR T cells) in older adults ...
Safety and efficacy of autologous humanized CD19 CAR-T ...Encouragingly, humanized scFv has demonstrated equivalent anti-tumor efficacy to murine scFv and prolonged survival compared with cells ...
Autologous CD19-Targeted CAR T Cells in Patients with ...We and others have previously described the safety and efficacy of autologous T cells modified to express anti-CD19 chimeric antigen receptors (CARs) in ...
Outcomes of PLAT-02 and PLAT-03: evaluating CD19 CAR T ...A phase 2 academic clinical trial of CD19 CAR T cells demonstrates durable remissions with a 1-year LFS in low disease burden groups of >90% ...
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