A Clinical Study of CAR-T Cells in the Treatment of Relapsed and Refractory Hematological Malignancies

NCT ID: NCT04008524

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed and Refractory Hematological Malignancies

Interventions

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CAR-T cells

Chimeric Antigen Receptor-T cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

* 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 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;
* 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.


* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juventas Cell Therapy Ltd.

INDUSTRY

Sponsor Role collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Hematology & Blood Diseases Hospital

Tianjin, , China

Site Status AVAILABLE

Countries

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China

Central Contacts

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Ying Wang, Dr.

Role: CONTACT

+86-22-23909278

Facility Contacts

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Ying Wang, Dr.

Role: primary

86-22-23909278

Other Identifiers

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QT2019006

Identifier Type: -

Identifier Source: org_study_id

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