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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
Study Summary
This trial is testing a new cancer treatment involving CAR T cells (a type of immune cell) for people with B-ALL (a type of blood cancer) who are in first complete remission with minimal residual disease. The trial will enroll 10 patients and assess them for safety and tolerability of the treatment.
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 outcome measures
Assessment of minimal residual disease by next generation sequencing
Duration of B-cell aplasia
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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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,734 Previous Clinical Trials
2,148,869 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How perilous is the administration of CD19 Directed CAR T Cell to patients?
"Due to the lack of evidence in Phase 1 trials, our team rates CD19 Directed CAR T Cell's safety as a low score (1) on a scale from 1-3."
Answered by AI
Is enrollment currently available for this investigation?
"According to data hosted on clinicaltrials.gov, the recruitment process for this medical study has been paused since September 12th 2022. Nonetheless, there are still 1,497 other trials currently enrolling patients."
Answered by AI
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