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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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is either mixed phenotype acute leukemia or Burkitt's lymphoma.My blood cancer is not in remission.I am currently fighting an infection that needs medicine to manage.I am experiencing symptoms or have test results showing brain or spinal cord disease.I am capable of becoming pregnant and have a negative pregnancy test.My side effects from previous treatments are mild or gone.I haven't had a heart attack or other major heart issues in the last year.I have a history of HIV or hepatitis B/C.I have been cancer-free for 3 years, except for non-melanoma skin cancer or carcinoma in situ.My B-cell ALL is in its first complete remission.I can take care of myself but might not be able to do heavy physical work.I am 18 years old or older.I do not have any health conditions that could affect the study's results.I have undergone CAR T therapy before.I have a blood clot that isn't controlled with steady medication.My leukemia has returned or didn't respond to treatment, and tests show minimal disease.My blood, kidney, liver, heart, and lung functions are all within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: UCD19 CAR T Infusion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.