What side effects are associated with this type of intervention?

Common treatments for Acute Lymphoblastic Leukemia (ALL), including CAR T cell therapies targeting CD19, are associated with significant side effects. These include cytokine release syndrome (CRS), which can range from mild to severe, neurotoxicity, prolonged cytopenias, increased risk of infections, and hypogammaglobulinemia. Traditional chemotherapy regimens, such as those involving cytarabine and anthracyclines, can cause myelosuppression, cardiotoxicity, and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several CAR T-cell therapies for the treatment of Acute Lymphoblastic Leukemia (ALL) that target CD19-expressing B cells. Notably, tisagenlecleucel (Kymriah) was the first CAR T-cell therapy approved for pediatric and young adult patients with refractory or relapsed B-cell ALL. Another significant approval is for brexucabtagene autoleucel (Tecartus), which is used for relapsed or refractory mantle cell lymphoma but also targets CD19. These therapies work by modifying a patient's T cells to express a receptor that targets and eliminates CD19-positive B cells, similar to the UCD19 CAR T cells being studied.

What other types of research exist?

Promising novel alternatives to UCD19 CAR T cells for ALL patients include: 1) Bispecific T-cell engagers (BiTEs) such as blinatumomab, which targets CD19 and CD3 to engage T cells in killing B cells. 2) CAR T cells targeting other antigens like CD22 (e.g., m971 CAR T cells). 3) Antibody-drug conjugates (ADCs) like inotuzumab ozogamicin, which targets CD22. 4) Novel small molecule inhibitors and immunomodulatory drugs that are currently under investigation in clinical trials.

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CAR T-cell Therapy

CAR T Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1

Recruiting

Led By Marc Schwartz, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment using modified immune cells to target and destroy remaining cancer cells in adults with B-ALL who are in remission but still have some cancer left. The goal is to see if this approach is safe and effective. Modified immune cells have shown remarkable success in helping patients with recurring B-ALL achieve remission again.

Who is the study for?

Adults with B-cell ALL in first complete remission but still showing minimal residual disease can join this trial. They must be fit enough for treatment (ECOG ≤ 2), have adequate organ function, and not be pregnant or planning pregnancy. Excluded are those with previous CAR T therapy, active CNS leukemia, uncontrolled infections, HIV/hepatitis B/C, certain heart conditions, or a history of other cancers within 3 years.

What is being tested?

The trial is testing UCD19 CAR T cell therapy's safety and effectiveness in adults with acute lymphoblastic leukemia who are in remission but have some remaining cancer cells. It involves collecting patients' immune cells, modifying them to target cancer cells better and then infusing them back into the patient after chemotherapy.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as fever and fatigue (cytokine release syndrome), neurological issues like confusion or seizures (neurotoxicity), blood cell count changes leading to increased infection risk, and infusion-related reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 6, and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 6, and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of UCD19 CAR T in Adults With B-ALL in first complete remission with MRD Positivity: occurrence and frequency of Adverse Events (AEs)

Safety of UCD19 CAR T in Adults With B-ALL in first complete remission with MRD Positivity: occurrence of Dose Limiting Toxicities (DLTs)

Secondary study objectives

Event Free Survival (EFS) at 12 and 24 months post UCD19 CAR T infusion

Chimeric Antigen Receptor T-Cell Therapy

Overall response rate (ORR) at 1, 3, 6, and 12 months post UCD19 CAR T infusion as measured by MRD.

Other study objectives

Assessment of minimal residual disease by next generation sequencing

Duration of B-cell aplasia

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: UCD19 CAR T InfusionExperimental Treatment1 Intervention

Lymphodepleting chemotherapy followed by infusion of UCD19 CAR T cells. Infusion is subject to a seven (7) day delay following chemotherapy completion if needed for resolution of clinical toxicities or to allow for product release.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Acute Lymphoblastic Leukemia (ALL) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, which is essential for eliminating leukemic cells. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), inhibit specific proteins involved in cancer cell growth and survival, providing a more precise treatment. Immunotherapy, including CAR T-cell therapy like UCD19 CAR T cells, involves engineering a patient's T cells to express chimeric antigen receptors that target and destroy CD19-expressing B cells, which are prevalent in B-ALL. This targeted approach is crucial for ALL patients as it offers a highly specific and effective method to eradicate leukemic cells, potentially improving outcomes and reducing the likelihood of relapse.