Phase 1 Lymphoma Trial, Recruiting NCT05535855 Sponsor: University of Colorado, Denver Condition: Lymphoma
Back to Lymphoma

Phase 1 Lymphoma Trial, Recruiting

NCT05535855
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be 18 years of age or older (there is no upper age limit)
  • You must be well enough to carry out basic daily activities — you may need some help but should not be completely unable to care for yourself (confirm with trial site)
  • You must have been diagnosed with B-cell acute lymphoblastic leukemia (a type of blood cancer) and be in your first complete remission, meaning your cancer has responded to initial treatment
  • Traces of cancer cells must still be detectable in your blood using sensitive tests, even though you are in remission — specific testing methods and timing depend on your cancer type (confirm with trial site)
  • You must have enough of a certain type of immune cell (CD3 T cells) in your blood within 21 days before a cell collection procedure
  • Any side effects from previous treatments must have mostly settled down to a mild or manageable level
  • Your bone marrow must be producing enough blood cells — specifically, your white blood cell and platelet counts must meet minimum levels
  • Your kidneys must be working well enough, based on blood tests
  • Your liver must be working well enough, based on blood tests
  • Your bilirubin (a substance processed by the liver) must be at an acceptable level — a slightly higher level may be allowed if you have a condition called Gilbert's syndrome
  • Your heart must be pumping blood effectively, with no significant fluid around the heart and no major abnormalities on a heart tracing test
  • Your lungs must be working well enough, with no significant fluid around the lungs, oxygen levels above 92% while breathing normal air, and lung function tests showing at least 50% of expected capacity
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before joining
  • If you could become pregnant or father a child, you must be willing to use reliable birth control during the study and for 12 months after receiving the treatment
  • You must be able to understand and sign a consent form agreeing to take part
  • You must be willing to take part in a long-term follow-up study

Who may not be able to join:

  • You have previously received a type of treatment called CAR T cell therapy
  • Your leukemia has come back or has not responded to treatment, including if you were previously free of detectable cancer cells but cancer traces have returned
  • You have a mixed type of leukemia or a specific type called Burkitt's lymphoma
  • Your leukemia is not in remission at the time of joining (remission means less than 5% cancer cells in the bone marrow)
  • You currently have signs of leukemia affecting your brain or spinal cord, or imaging scans show cancer there — however, if this was treated in the past and there is no current evidence, you may still be eligible
  • You have had another cancer in the past, unless you have been cancer-free for at least 3 years — certain skin cancers and very early-stage cancers in specific locations may be exceptions
  • You have an active, uncontrolled infection that requires treatment with antibiotics or antifungal/antiviral medicines — minor infections that are responding to treatment may be acceptable
  • You have a known history of HIV, hepatitis B, or hepatitis C infection
  • You have had a heart attack, heart procedure, unstable chest pain, or other significant heart condition within the past 12 months, or leukemia has spread to your heart
  • You have a blood clot (in a vein) that is not being managed with a stable treatment
  • You have any other medical condition that the study doctors feel could interfere with the safety or results of the trial
  • You have had a severe allergic reaction to any medicines used in this study
  • You are a woman planning to become pregnant during the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mathew Angelos, MD, University of Colorado, Denver

Phone: 17208480628

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
24 January 2024
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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); Preliminary efficacy of UCD19 CAR T infusion at the MTD in adult B-ALL patients at first complete remission with MRD positivity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov