Status:
UNKNOWN
ET019003-T Cells in Relapsed/Refractory CD19+ B-Cell Leukemia and Lymphoma
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Eureka(Beijing) Biotechnology Co., Ltd.
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a single center, open-label, 3+3 dose escalation, phase 1 study to evaluate the efficacy and safety of ET019003-T cells therapy for patients with relapsed/refractory CD19+ acute lymphoblastic ...
Detailed Description
ET019003-T cells is a human anti-CD19 CAR-T cells by fusing the anti-CD19 antibody Fab domain with the transmembrane and intracellular domains from the γδTCR, which can avoid mispairing with the T cel...
Eligibility Criteria
Inclusion
- Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
- Male or female, aged 18 to 75 years (including 18 and 75 years old).
- Pathologically confirmed CD19+ B-cell malignancies, and patients met the following criteria for refractory or relapsed B-cell malignancies.
- A. Refractory/relapsed B-cell lymphoblastic leukemia (meeting one of the following) i. Recurrence within 6 months after first remission. ii. Primary refractory disease which cannot achieve complete remission (CR) after 2 cycles of standardized chemotherapy regimen.
- iii. Failure to achieve CR or relapse after one line or multiple lines of salvage chemotherapy.
- iv. Not suitable for hematopoietic stem cell transplantation (HSCT), or abandon HSCT due to various restrictions, or relapse after HSCT.
- B. Refractory/relapsed B-cell lymphoma (Meeting 1 of the first 3 items plus item 4) i. Tumor shrinkage less than 50% or disease progression after 4 cycles of standard chemotherapy.
- ii. Achieved CR after standard chemotherapy, but relapsed within 6 months. iii. Two or more relapses after CR. iv. Subjects must have received adequate treatment in the past, including anti-CD20 monoclonal antibody and combination chemotherapy with anthracyclines.
- Having a measurable or evaluable lesion:
- A. Patients with lymphoma require a single lesion≥15mm or 2 or more lesions≥10mm.
- B. Patients with leukemia require persistent positive or positive relapse of bone marrow MRD.
- Patient's main organs functioning well:
- A. Liver function: ALT/AST ≤ 3 times the upper limit of normal (ULN) and total bilirubin≤2 times ULN.
- B. Renal function: Creatinine \< 220μmol/L. C. Pulmonary function: Indoor oxygen saturation≥95%. D. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥ 50%.
- ≥ 2 weeks since prior therapy at the time of enrollment, and the toxicity related to previous treatments returned to \< grade 1 (except for low grade toxicity such as alopecia).
- ECOG score≤ 2.
- Estimated survival time≥3 months.
Exclusion
- Women who are pregnant or breastfeeding.
- Women of child-bearing potential and all male participants can't use effective methods of contraception for at least 12 months following infusion.
- Patients fail to collect enough PBMC.
- Patients with other uncontrolled diseases, such as active infections.
- Active hepatitis B or active hepatitis C.
- Known HIV positive patients.
- Patients with active autoimmune diseases requiring systemic immunosuppressive therapy.
- Participants with other active malignancies (except non-melanoma skin cancer and cervical cancer) within 3 years.
- Patients with severe mental disorder or disorders of consciousness.
- Patients who need immediate treatment to control tumor progression or relieve tumor burden.
- Patients participated in other clinical treatments within 6 weeks.
- Patients with drug addiction.
- Patients with poor treatment compliance.
Key Trial Info
Start Date :
June 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04014894
Start Date
June 12 2019
End Date
July 1 2022
Last Update
November 12 2021
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022