Relapsed and Refractory Hematological MalignanciesNCT04008524
A Clinical Study of CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies
A study testing CAR-T cells in people with Relapsed and Refractory Hematological Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This project is intended to provide CAR-T cell therapy products for patients with severely life-threatening relapsed and refractory hematological malignancies. These patients have been previously treated sufficiently, currently have no other treatment methods available, and do not meet the inclusion criteria of other… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Relapsed and Refractory Hematological Malignancies
- What is being tested?
- CAR-T cells
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients suffering from a hematological malignancy that is severely life-threatening or seriously affects the patient's quality of life and has no effective treatment available, who not meet the inclusion/exclusion criteria for other clinical trials in the process of subject recruitment, or who are unable to obtain other study drugs or participate in clinical studies/trials for some reason (regional or time restriction, etc., or the recruitment of subjects for clinical studies/trials has ended but the drug has not yet been approved for marketing in China);
- Patients who are definitely diagnosed with the corresponding target-positive relapsed and refractory hematological malignancies, including but not limited to the following circumstances:
- Patients who do not meet the inclusion/exclusion criteria for existing clinical trials, such as age <18 years, ECOG >1, extramedullary recurrence, persistent or repeatedly positive for minimal residual disease;
- Patients who have relapsed after remission following CAR-T cell therapy, and are expected as judged by the investigator to benefit more from re-use of the same cell or sequential use of other CAR-T cells compared with the risk;
- The quantity of CAR-T cells produced does not meet the release criteria of production quality inspection, but is >0.1× 106/kg CAR positive T cells, and the investigator judges that the expected benefit of cell infusion is greater than the risk;
- The disease progresses rapidly after cell collection and before infusion, and the investigator judges that the expected benefit of cell infusion is greater than the risk;
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- Patients who have relapsed after autologous/heterogeneous hematopoietic stem cell transplantation (including those positive for minimal residual disease);
- Other circumstances where the investigator judges that the expected benefit of cell infusion is greater than the risk.
- Patients with appropriate bone marrow reserve: such as lymphocyte count >0.3×109/L;
- Patients with proper heart, lung, liver, kidney and coagulation functions;
- The selected patients or their legal representatives voluntarily sign the informed consent form.
Who cannot join
- Patients who are positive for any of HIV antibody, TP antibody, HBsAg and HCV antibody.
- Patients with a history of epilepsy or other central nervous system diseases.
- Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
- Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
- Available
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020
Ying Wang, Dr., 86-22-23909278, wangying1@ihcams.ac.cn
Jianxiang Wang, Dr.
About this study
This project is intended to provide CAR-T cell therapy products for patients with severely life-threatening relapsed and refractory hematological malignancies. These patients have been previously treated sufficiently, currently have no other treatment methods available, and do not meet the inclusion criteria of other clinical trial projects in the process of subject recruitment or meet their exclusion criteria. This project is designed to meet the urgent clinical needs of individual patients.
- Being tested
- CAR-T cells
- Keywords
- Relapsed, Refractory, Hematological malignancy, CAR-T cells
- Medical subject headings
- Recurrence, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cellsBiological
Chimeric Antigen Receptor-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008524
- Sponsor's protocol ID
- QT2019006
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2019
- Last updated
- 6 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04008524
- Acronym / sponsor ID
- QT2019006
- Keywords
- Relapsed, Refractory, Hematological malignancy, CAR-T cells
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- Juventas Cell Therapy Ltd.
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project is intended to provide CAR-T cell therapy products for patients with severely life-threatening relapsed and refractory hematological malignancies. These patients have been previously treated sufficiently, currently have no other treatment methods available, and do not meet the inclusion criteria of other clinical trial projects in the process of subject recruitment or meet their exclusion criteria. This project is designed to meet the urgent clinical needs of individual patients.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients suffering from a hematological malignancy that is severely life-threatening or seriously affects the patient's quality of life and has no effective treatment available, who not meet the inclusion/exclusion criteria for other clinical trials in the process of subject recruitment, or who are unable to obtain other study drugs or participate in clinical studies/trials for some reason (regional or time restriction, etc., or the recruitment of subjects for clinical studies/trials has ended but the drug has not yet been approved for marketing in China);
- Patients who are definitely diagnosed with the corresponding target-positive relapsed and refractory hematological malignancies, including but not limited to the following circumstances:
- Patients with appropriate bone marrow reserve: such as lymphocyte count >0.3×109/L;
- Patients with proper heart, lung, liver, kidney and coagulation functions;
- The selected patients or their legal representatives voluntarily sign the informed consent form.
Key exclusion criteria (4 listed)
- Patients who are positive for any of HIV antibody, TP antibody, HBsAg and HCV antibody.
- Patients with a history of epilepsy or other central nervous system diseases.
- Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
- Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-T cellsChimeric Antigen Receptor-T cells | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAR-T cells in people with Relapsed and Refractory Hematological Malignancies, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Wang, Dr. (+86-22-23909278, wangying1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.