Phase 1 Lymphoma Trial, Recruiting NCT07257419 Sponsor: St. Jude Children's Research Hospital Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT07257419
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:

For the patient receiving the transplant:

  • People aged 21 years or younger
  • People with a high-risk blood cancer where a stem cell transplant from a donor is the current standard treatment — this includes certain types of B-cell acute lymphoblastic leukaemia (ALL) that carry a protein called CD19, in first, second, or later remission (confirm with trial site for full list of qualifying cancers)
  • People who previously had leukaemia spread to the brain or spinal fluid, provided it has been treated and is now in remission
  • People whose heart is pumping well enough to meet specific minimum function levels (confirmed through heart testing)
  • People whose kidneys are filtering blood at or above a certain minimum level (confirmed through kidney function testing)
  • People whose lungs are working at or above a certain minimum level (confirmed through breathing tests, or blood oxygen levels if breathing tests cannot be done)
  • People with a general health and functioning score of 50 or above on a standard medical scale
  • People whose liver test results (bilirubin, ALT, and AST) are within acceptable ranges for their age

For the family member donating stem cells:

  • People who are at least 18 years old
  • People who are a family member who matches the patient on at least half of the required tissue-type markers (called HLA markers)
  • People who have tested negative for HIV
  • People who agree to use contraception until at least 2 weeks after completing the donation process, if sexually active
  • People who have completed the necessary medical and regulatory steps to be confirmed as an eligible donor, or for whom the treating doctor has documented an urgent medical need that allows donation to proceed under specific regulatory provisions

Who may not be able to join:

For the patient receiving the transplant:

  • People for whom a fully matched sibling donor or a closely matched unrelated donor is available within a suitable timeframe
  • People who have another active cancer in addition to the one being treated in this trial
  • People who have previously received a stem cell transplant from a donor
  • People who are pregnant (a negative pregnancy test within 14 days before joining is required for those who could become pregnant)
  • People who are breastfeeding
  • People who are not willing to use contraception until 6 months after the T cell infusion, if sexually active
  • People who currently have a serious, uncontrolled bacterial, fungal, or viral infection

For the family member donating stem cells:

  • People who are pregnant (a negative pregnancy test within 14 days before joining is required)
  • People who are breastfeeding

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 23 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: Swati Naik, MBBS, St. Jude Children's Research Hospital

Phone: 888-226-4343

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
Sponsor
St. Jude Children's Research Hospital
Registry
ClinicalTrials.gov
Start date
3 August 2026
Est. completion
1 December 2031

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To assess the safety of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.; To assess the feasibility of combining CD19-CAR(Mem) T cells after TCRαβ+/CD19 depleted haploidentical donor transplantation for pediatric patients with relapsed/refractory CD19+ B-cell malignancies.

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: 23 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