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| Name | Class |
|---|---|
| Beijing Gaobo Boren Hospital | UNKNOWN |
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This is an investigator-initiated dose-finding clinical study with the primary objective of evaluating the safety of CD5CART in the treatment of subjects with relapsed and refractory CD5 hematological malignancies and to explore the MTD of CD5CART treatment of relapsed and refractory subjects with CD5 hematological malignancies. At the same time, the effectiveness and pharmacokinetic characteristics of CD5CART treatment of relapsed and refractory CD5 hematological tumors in subjects were explored
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fully human CD5 chimeric antigen receptor T cell injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully human CD5 chimeric antigen receptor T cell injection | Drug | CA5 CART cells were reinfused |
|
| Measure | Description | Time Frame |
|---|---|---|
| Main objectives | To evaluate the safety of CD5 chimeric antigen receptor T cell injection (CD5CART) in the treatment of subjects with relapsed and refractory CD5 hematological tumors, and to explore the maximum tolerated dose (MTD). | one month |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The proportion of subjects evaluated as complete response (CR) and partial response (PR) according to Lugano 2014 efficacy evaluation criteria after CD5CART infusion | weeks 4 and 12 after CAR-T infusion |
| Time to Response (TTR) |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be enrolled:
1. CD5-positive B-cell lymphoma: B-cell lymphoma confirmed according to the National Comprehensive Cancer Network (NCCN) B-cell lymphoma clinical practice guidelines (2020 1st edition), and the tumor surface expresses CD5 (the test results within 60 days before signing the notice are acceptable for clinical practice, and the investigator will judge whether the test results of other hospitals are acceptable and whether they can be enrolled); According to the 2014 Lugano criteria, patients with B-cell lymphoma have at least one measurable lesion with a longest diameter ≥ 1.5 cm or bone marrow flow cytometry suggests bone marrow invasion, including:
2. CD5-positive T-cell lymphoma: Peripheral T-cell lymphoma confirmed according to the 2016 WHO classification criteria and the tumor surface expresses CD5 (if the current clinical practice is not suitable for sampling, the test results within 60 days before signing the information are acceptable, and the investigator will judge whether the test results of the other hospital are acceptable and whether they can be enrolled); According to the 2014 Lugano criteria, patients with T-cell lymphoma have at least one measurable lesion with a longest diameter ≥ 1.5 cm and no bone marrow invasion determined by bone marrow flow cytometry and receptor gene rearrangement (TCR/IGH) testing (and if PET-CT is available, it must not indicate elevated bone marrow metabolism); Refractory or relapsed after at least first-line therapy, including, but not limited to, the following peripheral T-cell lymphomas:
6. ECOG score 0-1 points. 7. Left ventricular ejection fraction (LVEF) ≥ 50% of the subjects diagnosed by echocardiography; Blood oxygen saturation > 91%.
8. Subjects and their spouses agree to take effective tools or drug contraceptives within one year after the subject signs the informed consent form until one year after CAR-T cell retransfusion; Female subjects of childbearing potential must have a negative serum or urine pregnancy test during the screening period.
9. Volunteer to participate in this trial and sign the informed consent form.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded:
1) Non-melanoma cured by resection such as basal cell carcinoma of the skin; 2) Cured carcinoma in situ such as cervical cancer, bladder cancer or breast cancer, etc.; 3) No recurrence of other primary cancers after treatment for more than 5 years.
11. History of solid organ transplantation. 12. Subjects with previous autoimmune diseases (mainly cellular immune abnormalities), immunodeficiency or subjects requiring immunosuppressant therapy.
13. Receiving other interventional clinical trial drugs within 3 months before signing the informed consent form (ICF); 14. Women who are pregnant or breastfeeding; 15. Suffering from mental illness or consciousness disorder or central nervous system disease; 16. Previous treatment toxicity has not been resolved to baseline or grade ≤2 (NCI-CTCAE v5.0, except alopecia); 17. Medication use:
18. Active pulmonary infection. 19. Contraindications to peripheral blood apheresis. 20. Subjects who are considered unsuitable to participate in this trial by the investigator after careful consideration.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Hospital of Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Time from CAR-T infusion to first documentation of response evaluated by an IRC or investigators
| in 2 years post CAR-T infusion |
| Best overall response rate (BOR) | The proportion of subjects who received CD5CART infusion and had the best efficacy evaluation as PR or CR | within 3 months post CAR-T infusion |
| Duration of response (DOR) | The time from the first assessment of CR/PR to the first assessment of PD or death from any cause in the subject after receiving CD5CART infusion | Minimum of 2 years post CAR-T infusion |
| Progression-free Survival (PFS) | The time from CD5CART infusion to the first occurrence of disease progression or death from any cause in the efficacy assessment of the subject; | Minimum of 2 years post CAR-T infusion |
| Overall survival (OS) | Time from CAR-T infusion to time of death due to any cause | Minimum of 2 years post CAR-T infusion |