Phase 2 Lymphoma Trial, Recruiting NCT05442515 Sponsor: National Cancer Institute (NCI) Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05442515
Recruiting Phase 2

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 have been diagnosed with a confirmed B cell blood cancer (B-cell ALL), a type of leukemia that has changed into a form of blood cancer (CML transformed to ALL), or a fast-growing lymphoma (such as Burkitt's lymphoma, diffuse large B-cell lymphoma, or a slow-growing lymphoma that has turned aggressive)
  • Your cancer has come back or stopped responding to at least one standard chemotherapy treatment and at least one additional treatment attempt; if your cancer has a specific genetic marker called Philadelphia chromosome, you must also have tried a targeted pill-based therapy (tyrosine kinase inhibitor)
  • You are not able to have, have chosen not to have, or have already had a stem cell transplant that did not work
  • You are unable to access, do not qualify for, or have already tried a commercially available CD19 CAR T-cell therapy without success
  • There is still evidence of cancer in your body at the time of joining the trial
  • Your cancer cells show the right levels of proteins called CD19 and/or CD22 on their surface (the exact requirements depend on which group within the trial you would join — confirm with trial site)
  • For one specific group in the trial: you are between 3 and 39 years old at the time of joining
  • You are well enough to carry out some daily activities (your doctor will assess this using a standard scale — confirm with trial site)
  • Your blood counts, liver, and kidney are working well enough to meet specific minimum levels set by the trial (your doctor will check these with blood tests)
  • Your heart is pumping well enough, based on a specific heart function measurement (confirm with trial site)
  • Your oxygen levels in your blood are above 92% while breathing normal room air at rest
  • Participants with leukemia that has reached the fluid around the brain and spine, but only at an early stage (CNS1 or CNS2), may still be eligible
  • If you could become pregnant or father a child, you must be willing to use effective birth control from enrollment until 12 months after finishing treatment (for women) or 4 months after finishing treatment (for men)
  • If you are breastfeeding or plan to breastfeed, you must agree to stop while on treatment and for 1 month after receiving the CAR T-cell therapy
  • You (or your legal guardian/representative) are willing and able to understand and sign a consent form
  • You (or your legal guardian/representative) are willing to also enroll in a separate long-term safety follow-up study linked to this trial

Who may not be able to join:

  • Your cancer has spread heavily to the brain or spinal fluid (CNS3 disease), you have worsening neurological symptoms from CNS disease, or scans show active lymphoma in the brain
  • You have an extremely high number of cancer cells circulating in your blood (50,000 or more blast cells per microliter)
  • You have a positive pregnancy test at the time of screening
  • You have not waited long enough since your last cancer treatment before joining — specific waiting periods apply depending on the type of treatment you received (confirm with trial site for your specific situation)
  • You have active HIV infection
  • You have active hepatitis B or hepatitis C infection
  • You have another active cancer, unless it was fully treated at least two years ago and you are now in remission (an exception is made for a very early-stage cervical condition)
  • You have had a severe allergic reaction to substances similar to those used in this trial or in making the cell therapy
  • You have another serious illness that is not under control, or personal circumstances that would make it difficult to follow the trial requirements, or that your doctor feels would put you at unacceptable risk

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 20 July 2026
Phase 2: approximately ~30% 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: Sara K Silbert, M.D., National Cancer Institute (NCI)

Phone: (240) 760-6970

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 2
Registry
ClinicalTrials.gov
Start date
28 December 2022
Est. completion
1 July 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety; Efficacy

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: 20 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