Phase 2 Leukaemia Trial, Recruiting NCT07244406 Sponsor: Hebei Senlang Biotechnology Inc., Ltd. Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT07244406
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:

  • People who are willing and able to follow the study schedule, including visits, treatments, and tests as required by the trial
  • People aged between 3 and 25 years (inclusive) at the time of signing the consent form, either male or female
  • People who have been diagnosed with B-cell acute lymphoblastic leukaemia (a type of blood cancer) that has come back or stopped responding to treatment
  • People whose bone marrow test at screening shows more than 5% abnormal cancer cells (blasts)
  • People whose cancer cells carry a specific marker called CD19, confirmed by a laboratory test on bone marrow or blood at screening
  • People with a specific type of this leukaemia linked to the Philadelphia chromosome (Ph+), provided they meet the relapsed/refractory criteria and have either tried and failed at least two targeted drug treatments (called TKIs), cannot tolerate TKIs, or have a medical reason they cannot use TKIs — unless a specific genetic mutation called T315I is present (confirm with trial site)
  • People whose doctors estimate they are likely to survive for more than 3 months

Who may not be able to join:

  • People whose leukaemia has returned only in areas outside the bone marrow (isolated extramedullary relapse)
  • People diagnosed with Burkitt lymphoma or Burkitt leukaemia (a related but different type of blood cancer)
  • People who have had active or moderate-to-severe graft-versus-host disease (a complication that can occur after a stem cell transplant) within the 4 weeks before signing the consent form, or who have received any treatment for this condition within 4 weeks before the treatment infusion
  • People who have an active infection that is not under control at the time of signing the consent form or at the time of the cell collection procedure
  • People who have previously received any CAR-T cell therapy or other cell or gene-based therapy
  • People who have received experimental drugs or cancer-fighting treatments within 4 weeks, or within 5 times the drug's natural clearing time from the body (whichever period is longer), before the cell collection procedure
  • People who have active lung inflammation or lung disease at the time of signing the consent form
  • People whom the trial doctors consider unable to follow the study requirements, or who are otherwise not suitable for the trial for any reason

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 8 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: Xiaojun Huang, Peking University People's Hospital

Phone: 010-88325229

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
Sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Registry
ClinicalTrials.gov
Start date
10 January 2025
Est. completion
31 March 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective response rate after S1904 infusion [Effectiveness]

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: 8 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