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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 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.

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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,809 Previous Clinical Trials
2,822,255 Total Patients Enrolled
Marc Schwartz, MDPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
90 Total Patients Enrolled

Media Library

UCD19 CAR T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05535855 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: UCD19 CAR T Infusion
Acute Lymphoblastic Leukemia Clinical Trial 2023: UCD19 CAR T Highlights & Side Effects. Trial Name: NCT05535855 — Phase 1
UCD19 CAR T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05535855 — Phase 1
~5 spots leftby Jul 2025