Patient Derived CD19 specific CAR T cells also expressing an EGFRt for Leukemia

1
Effectiveness
1
Safety
Children's Hospital Oakland, Oakland, CA
Leukemia+1 More
Patient Derived CD19 specific CAR T cells also expressing an EGFRt - Biological
Eligibility
< 65
All Sexes
Eligible conditions
Leukemia

Study Summary

This study is evaluating whether a genetically modified T cell can be used to treat leukemia.

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Eligible Conditions

  • Leukemia
  • CD 19+ Acute Leukemia

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Patient Derived CD19 specific CAR T cells also expressing an EGFRt will improve 3 primary outcomes and 3 secondary outcomes in patients with Leukemia. Measurement will happen over the course of 28 days.

28 days
Number of Participants who have a Releasable Cell Product Generated
3 years
Number of participants who have T cells ablated with cetuximab
30 days
Number of Participants With Adverse Events
63 days
Number of participants with an MRD negative complete remission after T cells infusion
Number of participants with recrudescence or development of acute GVHD
Persistence of functional CD19 CAR+ T cells

Trial Safety

Trial Design

3 Treatment Groups

No Control Group
Cohort 1

This trial requires 167 total participants across 3 different treatment groups

This trial involves 3 different treatments. Patient Derived CD19 Specific CAR T Cells Also Expressing An EGFRt is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Cohort 1
Biological
This cohort will determine the maximum tolerated dose of the Patient Derived CD19 specific CAR T cells also expressing an EGFRt and is restricted to patients with a prior history of allo-HCT
Cohort 2A
Biological
This cohort is for patient who have a history of allo-HCT with recurrence of disease post HCT and they will receive the MTD of Patient Derived CD19 specific CAR T cells also expressing an EGFRt determined in cohort 1.
Cohort 2B
Biological
This cohort is restricted to patients wtih no prior history of allo-HCT and they will receive the MTD of Patient Derived CD19 specific CAR T cells also expressing an EGFRt determined in cohort 1

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 years for reporting.

Who is running the study

Principal Investigator
R. G.
Rebecca Gardner, Associate Medical Director, Immunotherapy Coordinating Center
Seattle Children's Hospital

Closest Location

Children's Hospital Oakland - Oakland, CA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Leukemia or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with CNS involvement are eligible provided that they are asymptomatic and in the opinion of the study PI have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T cell infusion. Patients that have a significant neurologic deterioration will be not be eligible for T cell infusion until alternate therapies result in neurological stabilization.
Patients must be ≥12 months of age and <27 years of age at the time of study enrollment.
Must be ≥10kg
Confirmed CD19+ leukemia recurrence defined as ≥0.01% disease in the marrow or isolated extramedullary disease following allogeneic HCT. [N.B. Study closed to enrollment of leukemia subjects]
OR No prior history of allogeneic HCT (one of the following)
2nd or greater relapse, with or without extramedullary disease (isolated extramedullary disease is eligible)
1st marrow relapse at end of 1st month of re-induction with marrow having ≥0.01% blast disease, with or without extramedullary disease
Primary Refractory as defined as having M2 or M3 marrow after induction
Subject has indication for HCT but has been deemed ineligible
OR CD19+ Non-Hodgkin Lymphoma (NHL) refractory or relapsed with no known curative therapies available [N.B. Study remains open to enrollment of lymphoma subjects]

Patient Q&A Section

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

What is patient derived cd19 specific car t cells also expressing an egfrt?

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In our hands this is an extremely rare combination of two CD19-expressing, CD19-negative Cd19+ specific CD8+ cells, that is likely to be involved with the excellent initial remission and late control of a non-Hodgkin's type cancer such as CLCN6.

Unverified Answer

Can leukemia be cured?

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When patients are in the most severe phases of leukemia and only have a slim chance of survival, some patients may experience complete remission after chemotherapy. A small percentage of patients can be cured, but patients who recover from this remission remain susceptible to infection, and rarely progress to a fatal leukemia.

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What is leukemia?

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We're always looking to get a better understanding of cancer, and if cancer can be the cause of disease we're always looking for the cause of the cancer. To help us we use the most modern, safe and effective treatments available.

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How many people get leukemia a year in the United States?

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Leukemia and lymphoma are uncommon in the United States, accounting for 0-0.1% of cancer diagnoses a year. However, each year, an estimated 41,000 Americans are diagnosed through early onset lymphomas and 15,000 are diagnosed through acute myeloid leukemia. These events are more common in younger patients and occur more often in females.

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What are the signs of leukemia?

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Leukemias are a group of disorders involving malignant growth of blood cells, and may be caused by genetic, environmental, or environmental causes. Symptoms may include vomiting, weight loss, weakness, lack of feeling, and anemia. The presence of a leukemic reaction should alert the physician to consider a diagnosis of leukemia. The diagnosis of leukemia is achieved by analyzing blood, bone marrow, and other tissues using examination techniques and laboratory tests.

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What are common treatments for leukemia?

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Most patients presenting to the hospital with first diagnosis of acute leukemia will be treated in accordance with the treatment guidelines published by the NCI. If the patient has not responded to a full course of therapy, and the current treatment cannot eradicate the disease, a bone marrow evaluation may be performed. While bone marrow is a major resource for patients with aggressive forms of the disease, it will play a less important role in patients with chronic or promyelocytic leukemias. These patients will receive a standard course of treatment.

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What causes leukemia?

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While most childhood cancers can be categorized as leukemias, there are numerous forms of leukemia. It is important for pediatricians to not just focus on leukemia-related cancers from infancy to adolescence, but to also consider leukemia as a cause of adult-type leukemia.

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What does patient derived cd19 specific car t cells also expressing an egfrt usually treat?

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The presence of such a CD19-positive cell population in the tumor did not significantly correlate to any clinical outcome and most likely is a bystander instead of a direct antitumor response. However, in cases where the CD19-positive tumor populations contained also EGFR(t) and/or CD19(-) cells, there are strong indications that they had some prognostic value. Our observations pave the way for further trials of the CD19(-)/-CD45RA(+)CD38(+)CD3(+) progeny cells in refractory CML.

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What are the chances of developing leukemia?

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In the developed world, there are three significant risk factors associated with leukaemia: male gender, older age, and family history of blood cell cancers. The most significant risk factors for leukaemia are: age ≥60 years, male sex, and a family history of blood cell cancers.

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What are the latest developments in patient derived cd19 specific car t cells also expressing an egfrt for therapeutic use?

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It is widely accepted that anti-CD19-loaded CD19-specific T cells may represent a promising therapeutic strategy, since it is believed the CD19-specific CD8+ T cells of the host can recognize and attack the CD19-expressing leukemia cells; CD19-specific CD19-T cells can directly stimulate this process for the control of leukemia growth and progression. Findings from a recent study of this study show that CD19-expressing T cells may be used to treat patients with AML in the next clinical trial with the CD19-specific CD19-T cells.

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What is the survival rate for leukemia?

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We found a significant survival advantage for patients following ALL but not for patients who received chemotherapy-MRD, and for patients with PML, those who received chemotherapy-MRD, those who received chemotherapy alone, and those who received no chemotherapy have a relatively equal survival rate for those with ALL. As with all cancer, a more effective treatment, either adjuvant or neoadjuvant, or new drugs are needed to achieve the optimal remission rate. See: Cancer Treatment, Cancer Surgery. The survival for ALL was lower in older patients who were less fit, or not as strong of a candidate for this treatment, so their survival might be the reason for higher levels of leukemia (more leukemias).

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How does patient derived cd19 specific car t cells also expressing an egfrt work?

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Results from a recent paper proposes one of the first approaches to create CAR-T cell targeting the specific CD19 target antigen. Further in vivo trials are now warranted to assess the therapeutic potential of this cell population.

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