Study Stopped
The study is not initiated and we want it to be withdrawn.
Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies
Safety and Efficacy Study of Novel CAR-T Cell Therapy in the Treatment of Hematopoietic and Lymphoid Malignancies
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with hematopoietic and lymphoid malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2020
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 22, 2022
CompletedFirst Posted
Study publicly available on registry
August 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedMarch 1, 2023
February 1, 2023
5.4 years
August 22, 2022
February 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (3)
Duration of Overall Response (DOR)
12 months
Progression-Free Survival (PFS)
12 months
Overall survival (OS)
12 months
Study Arms (1)
Autologous CAR-T cells
EXPERIMENTALA 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.
Interventions
Administered according to package insert
Eligibility Criteria
You may qualify if:
- Ability to understand and the willingness to sign informed consent.
- Patients with relapsed or refractory Acute Myeloid Leukemia (AML), B-cell Non-Hodgkin's Lymphoma (B-NHL), Multiple Myeloma (MM), Adult T-cell Leukemia/Lymphoma (ATL), B-cell Acute Lymphoblastic Leukemia (B-ALL) after at least two cycles of first-line therapy or autologous hematopoietic stem cell transplantation (auto-HSCT).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
- Adequate organ functions:
- Sufficient bone marrow function evaluated by investigator to receive lymphodepleting preparative regimen;
- Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance rate (as estimated by Cockcroft Gault) \> 30 mL/min/1.73 m\^2;
- Alanine aminotransferase (ALT) ≤ 5×ULN; and total bilirubin (TBIL) \<2.0mg/dL; TBIL of patients with Gilbert's Syndrome or liver involvement must less than 3.0 mg/dL;
- Left ventricular ejection fraction (LVEF) \> 40%.
- Subjects who have previously received CD19 targeted therapy must have biopsy-proven lymphoma lesions still express CD19 antigen.
You may not qualify if:
- Lymphomas involving only the central nervous system (CNS) (subjects with secondary CNS lymphomas are admitted).
- History of another malignancy that has not been in remission for at least 2 year (the following conditions may be excluded from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumor with low probability of recurrence, limited-stage prostate cancer after treatment, biopsy-proven cervical carcinoma in situ, or PAP smear showing squamous epithelium internal lesions).
- History of treatment with Alemtuzumab within 6 months prior to leukapheresis, or Fludarabine or Cladribine within 3 months prior to leukapheresis.
- Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection.
- Uncontrolled fungal, bacterial, viral, or other infection.
- Acute or chronic graft-versus-host disease (GVHD).
- History of any of the following cardiovascular diseases within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stent, myocardial infarction, unstable angina, or other clinically significant heart disease.
- History or clinical evidence of CNS disease.
- Female subjects who are pregnant or lactating.
- Prior CAR-T therapy or other genetically modified T cell therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Pudong Hospitallead
- UTC Therapeutics Inc.collaborator
Study Sites (1)
Shanghai Pudong Hospital, Fudan University Affiliated Pudong Medical Center
Shanghai, Shanghai Municipality, 201399, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhiguo Long
Shanghai Pudong Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2022
First Posted
August 24, 2022
Study Start
August 1, 2020
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2026
Last Updated
March 1, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share