Early Phase 1 Lymphoma Trial, Recruiting NCT04532203 Sponsor: Zhejiang University Condition: Lymphoma
Back to Lymphoma

Early Phase 1 Lymphoma Trial, Recruiting

NCT04532203
Recruiting Early 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 people with B-ALL (a type of blood cancer affecting B cells):

  • People aged 3 to 70 years old
  • People who have been diagnosed with B-ALL confirmed through laboratory testing, following recognised medical guidelines
  • People whose B-ALL has come back or has not responded to treatment, meeting at least one of these conditions: the cancer did not go into remission after standard chemotherapy; remission lasted less than 12 months after the first round of treatment; one or more follow-up treatments have not worked; or the cancer has relapsed two or more times
  • People whose bone marrow testing shows a certain level of abnormal cells above a set threshold (confirm with trial site)
  • People who test negative for the Philadelphia chromosome, or who test positive but cannot tolerate or have not responded to two targeted therapies called TKI treatments

For people with B-NHL (a type of lymphoma affecting B cells):

  • People aged 18 to 75 years old
  • People who have been diagnosed with specific types of B-NHL — including DLBCL, follicular lymphoma, DLBCL transformed from CLL/SLL, PMBCL, or HGBCL — confirmed through laboratory testing using recognised classification guidelines
  • People whose B-NHL has come back or has not responded to treatment, meeting at least one of these conditions: the cancer did not respond to or came back after two or more lines of chemotherapy; the cancer showed primary resistance to treatment; or the cancer relapsed after a stem cell transplant using the person's own cells
  • People who have at least one measurable area of disease that can be assessed using standard imaging criteria

For all participants (both B-ALL and B-NHL):

  • People who have confirmed or strongly suspected involvement of the cancer in the central nervous system (brain and spinal cord)
  • People whose liver and kidney function test results fall within the ranges required by the trial (confirm with trial site)
  • People whose heart scan shows the heart pumping at 50% efficiency or above
  • People with no active lung infection and whose blood oxygen level in normal indoor air is at least 92%
  • People whose expected survival is at least 3 months
  • People who are functioning reasonably well in daily life, based on a standard medical scale scoring 0 to 2 (confirm with trial site)
  • People, or their legal guardians, who agree to take part and sign a consent form

Who may not be able to join:

  • People with a history of serious brain or neurological conditions, including head trauma, loss of consciousness, epilepsy, or blood vessel-related brain disease
  • People with a history of serious heart conditions, including a prolonged QT interval on a heart tracing or severe irregular heartbeat
  • People who are pregnant or breastfeeding
  • People with a severe active infection (minor infections such as urinary tract infections or bacterial throat infections are not automatically excluded — confirm with trial site)
  • People with an active hepatitis B or hepatitis C infection
  • People who have taken steroid medications throughout the body (not inhaled steroids) within the two weeks before screening
  • People who have previously received CAR-T cell therapy or any other genetically modified T cell treatment
  • People whose kidney or liver function test results fall outside the limits set by the trial (confirm with trial site)
  • People with other serious uncontrolled health conditions considered unsuitable for the trial
  • People living with HIV
  • People in any situation where the trial doctor considers participation may raise safety concerns or affect the reliability of the results

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 27 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Phone: 86-13605714822

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
Early Phase 1
Sponsor
Zhejiang University
Registry
ClinicalTrials.gov
Start date
1 November 2020
Est. completion
1 November 2023

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose-limiting toxicity (DLT); Incidence of treatment-emergent adverse events (TEAEs)

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: 27 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