Phase 1 Leukaemia Trial, Recruiting NCT06173518 Sponsor: Autolus Limited Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT06173518
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:

  • Children and young people under 18 years old at the time of screening
  • Children weighing at least 6 kg at the time of screening
  • Children with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) that has come back or has not responded to previous treatment
  • Children with certain types of aggressive B-cell lymphoma (a cancer of the lymph system) that has come back or has not responded to treatment — including diffuse large B-cell lymphoma, Burkitt's lymphoma, primary mediastinal large B-cell lymphoma, or high-grade B-cell lymphoma
  • Children whose general health and ability to carry out daily activities meets a minimum score on a standard scale used by doctors (called Karnofsky or Lansky, depending on age)
  • Children with B-ALL whose cancer cells have been confirmed to carry a specific protein called CD19, based on a test done within 30 days before joining the trial
  • Children with adequately functioning kidneys, liver, lungs, and heart

Who may not be able to join:

  • Children diagnosed with a specific type of leukemia called chronic myelogenous leukemia in lymphoid blast crisis
  • Children with a significant history of, or current, nervous system problems that are not related to their leukemia
  • Children with an active or uncontrolled infection (fungal, bacterial, viral, or other) that requires treatment with systemic antimicrobial medicines
  • Children who received a stem cell transplant less than 3 months before the planned treatment infusion in this trial
  • Children who have previously received any CD19-targeted therapy other than a drug called blinatumomab
  • Children who experienced a severe (Grade 3 or higher) neurological side effect from blinatumomab in the past

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 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

Phone: +44 (0) 203 911 4385

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
Autolus Limited
Registry
ClinicalTrials.gov
Start date
16 November 2023
Est. completion
1 November 2027

Where this trial is recruiting

🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Frequency and severity of adverse events (AEs) and serious adverse events (SAEs); Incidence and duration of severe hypogammaglobulinemia; Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment

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