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

NCT04008524 | Unknown

• 1 other identifier: QT2019006
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Relapsed and Refractory Hematological Malignancies

Keywords

Relapsed; Refractory; Hematological malignancy; CAR-T cells

Interventions

CAR-T cells BIOLOGICAL

Chimeric Antigen Receptor-T cells

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• Juventas Cell Therapy Ltd.: collaborator

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, 300020, China

AVAILABLE

MeSH Terms

Conditions

Recurrence; Hematologic Neoplasms

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Central Study Contacts

Ying Wang, Dr.

CONTACT

+86-22-23909278; wangying1@ihcams.ac.cn

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Last Updated: August 6, 2025

Record last verified: 2025-02

Locations

CN (1)