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| Name | Class |
|---|---|
| UTC Therapeutics Inc. | INDUSTRY |
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The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.
CAR-T cells targeted CD19 have demonstrated unprecedented successes. Besides CD19, many other molecules such as CD123, BCMA, and CD7 may be potential in developing the corresponding CAR-T cells to treat patients with hematopoietic and lymphoid malignancies. UTC Therapeutics Inc. have developed an efficient platform for constructing CAR-T cells that can remodel of tumor microenvironment and enhance the anti-tumor immune response and persistence of CAR-T cells. In this study, all eligible subjects will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by investigational treatment, CAR-T cells. Safety and efficacy of the CAR-T cells will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous CAR-T cells | Experimental | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CAR-T cells. CAR-T cells targeted CD19/BCMA/CD123/CD7 are autologous genetically modified T cells. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous CAR-T cells | Biological | D0: CAR-T cells will be infused intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| TEAEs | Incidence and severity of Treatment Emergent Adverse Event. | 4 weeks |
| TRAEs | Incidence and severity of Treatment Related Adverse Events. | 4 weeks |
| AESIs | Incidence and severity of AEs of Special Interest. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) (PR+CR) | The proportion of patients with complete response(CR) or partial response(PR) | 12 months |
| Progression-Free Survival (PFS) | PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date. |
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Inclusion Criteria:
Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.
Positive expression of specific antigens.
Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.
Adequate organ functions:
Subjects must be able to understand the protocol and be willing to enroll the study, sign the informed consent, and be able to comply with the study and follow-up procedures.
Exclusion Criteria:
History of allergy to any of the drugs involved in the protocol.
History of cardiac diseases:
History of another malignancy tumor.
Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
Patients with any contraindications to allogeneic hematopoietic stem cell transplantation.
Uncontrolled fungal, bacterial, viral, or other infection.
Female subjects who are pregnant or lactating.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Lu | Contact | 86-13486090834 | 814871416@qq.com | |
| Dong Chen | Contact | 86-13805888089 | 13805888089@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Lu | The Affiliated People's Hospital of Ningbo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated People's Hospital of Ningbo University | Recruiting | Ningbo | Zhejiang | 315101 | China |
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| Fludarabine | Drug | D-5 to D-3: Fludarabine (30 mg/m^2/day) will be administered intravenously for 3 days. |
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| Cyclophosphamide | Drug | D-5 to D-3: Cyclophosphamide (500 mg/m^2/day) will be administered intravenously for 3 days. |
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| 12 months |
| Overall survival (OS) | OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date. | 12 months |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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