Phase 2 Leukaemia Trial, Recruiting NCT06503094 Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06503094
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 fully understand the trial and are willing to sign a consent form, attend all visits, and follow all study requirements.
  • People who have been confirmed by pathology or tissue testing to have a B-cell blood cancer that is positive for the CD19 or CD20 protein, and whose cancer has returned or has not responded to previous treatment.
  • People with one of these specific B-cell blood cancer types: B-cell acute lymphoblastic leukemia (B-ALL), a slower-growing B-cell lymphoma (such as CLL, FL, MZL, LPL, or HCL), or a faster-growing B-cell lymphoma (such as DLBCL, BL, or MCL).
  • People with leukemia whose bone marrow tests show the cancer is still detectable or has returned; or people with lymphoma who have at least one tumor measuring 15mm or more, or two or more tumors each measuring at least 10mm.
  • People whose general physical functioning is rated at 0, 1, or 2 on the ECOG scale, meaning they are able to carry out daily activities, possibly with some limitations (confirm with trial site).
  • People whose cancer cells have tested positive for the CD19 or CD20 protein through laboratory testing.
  • People whose doctors estimate they are likely to live for more than 3 months from the time of signing the consent form.
  • People with relapsed or treatment-resistant B-cell leukemia who meet at least one of these conditions: the cancer returned within 6 months of first going into remission; the cancer never went into full remission after 2 rounds of standard chemotherapy; the cancer did not fully respond to or returned after further chemotherapy; or a stem cell transplant was not possible, was declined, or the cancer returned after one.
  • People with relapsed or treatment-resistant B-cell lymphoma who meet at least one of the first four leukemia-related conditions listed above, and who have also previously received treatment with an anti-CD20 antibody drug and chemotherapy containing a specific class of drug called an anthracycline (confirm with trial site).

Who may not be able to join:

  • People with certain heart conditions, including atrial fibrillation, a heart attack in the past 12 months, a heart rhythm disorder affecting the QT interval, reduced heart pumping function on ultrasound, significant fluid around the heart, or severe heart failure (NYHA class III or IV).
  • People who currently have active graft-versus-host disease (a complication that can occur after a stem cell transplant).
  • People with a history of severe lung disease.
  • People who have another cancer that is at an advanced stage.
  • People with a serious or ongoing infection that cannot be brought under control.
  • People with a severe autoimmune disease or a serious condition affecting the immune system from birth.
  • People with active hepatitis B or hepatitis C, where blood tests show the virus is active and liver function is abnormal.
  • People with HIV or syphilis infection.
  • People who have had a severe allergic reaction to a biological medicine, including antibiotics, in the past.
  • People with certain neurological conditions that are not controlled, such as epilepsy, stroke-related brain injury, dementia, or cerebellar disease.
  • People who are pregnant, breastfeeding, or planning to become pregnant within 12 months.
  • People whose participation may increase health risks or affect the reliability of the trial results, as judged by the treating doctor.

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 28 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: Mei Heng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Phone: 027-8572600

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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Registry
ClinicalTrials.gov
Start date
14 January 2024
Est. completion
18 December 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Overall response rate (ORR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors; Incidence of Treatment-related Adverse Events; Complete response rate (CR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors; Partial response rate (PR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors

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: 28 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