Aurora, CONCT06559189Now EnrollingIRB Ready

B-cell Acute Lymphoblastic Leukemia Clinical Trial in Aurora, CO

Access cutting-edge b-cell acute lymphoblastic leukemia treatment through this clinical trial at a research site in Aurora. Study-provided care at no cost to qualified participants.

Sponsored by University of Colorado, Denver

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Expert Care in Aurora

Access b-cell acute lymphoblastic leukemia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related b-cell acute lymphoblastic leukemia treatment provided free

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Check if you qualify for this b-cell acute lymphoblastic leukemia clinical trial in Aurora, CO

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Why Participate?

  • No-Cost Study Care

  • Local to Aurora

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Aurora site if eligible
  4. 4Begin participation

About This B-cell Acute Lymphoblastic Leukemia Study in Aurora

This study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.

Sponsor: University of Colorado, Denver

Who Can Participate

Inclusion Criteria

Subjects must have a history of B precursor ALL with any of the following conditions:
Relapsed two or more times.
Relapsed at any time after allogeneic bone marrow transplant (BMT).
Relapse or refractory after single antigen targeting CAR T cell therapy. i. 90 days must have elapsed post previous CAR infusion prior to apheresis. d. Refractory to standard therapy as determined by the treating physician. e. Patient and/or parents declining BMT options and would prefer CAR T Therapy.
CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2).
Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines.
Males OR non-pregnant, non-lactating females.
Aged 3 months to 30 years (inclusive) at time of consent and enrollment.
Provision of a signed and dated consent form from parent or guardian (patients \< 18), the patient themselves (\> 18), or legally authorized representative (patient \> 18 who lack decision-making capacity) after standard of care (SOC) screening assessments are performed.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Willingness to participate in long-term follow-up protocol.

Exclusion Criteria

Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not limited to: seizures, paresis, aphasia, hemorrhage, dementia, psychosis, or movement disorders) as determined by the treating physician at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre- CD19x22 CAR T cell infusion.
History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
Less than 100 days post-transplant;
Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;
Less than 6 weeks post donor lymphocyte infusion (DLI).
Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe apheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or increased risk of cytokine release syndrome.
Evidence of severe organ dysfunction defined by:
Baseline oxygen saturation of \< 90% on room air
Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings
Transaminases \> 10x upper limit of normal (ULN) or bilirubin \> 5x the ULN, unless thought to be related to primary disease
Estimated Creatinine (Cr) clearance \< 60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance)
Subjects of childbearing or child-fathering potential that are not willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the investigational product
Known HIV infection or active Hepatitis B or Hepatitis C infection.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Aurora?

Yes, this clinical trial (NCT06559189) has an active research site in Aurora, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

B-cell Acute Lymphoblastic Leukemia Treatment Options in Aurora, CO

If you're searching for b-cell acute lymphoblastic leukemia treatment options in Aurora, CO, this clinical trial (NCT06559189) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Aurora research site is actively enrolling participants for this clinical trial. You'll receive care from experienced b-cell acute lymphoblastic leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all b-cell acute lymphoblastic leukemia clinical trials near you to find additional studies recruiting in your area.

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