Leukemia, Lymphoma, Myeloma, Relapsed/Refractory Hematological Malignancies
Conditions
Keywords
CD19 CAR-T, BCMA CAR-T, CD7 CAR-T, CD123 CAR-T
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALAutologous CAR-T cells
D0: CAR-T cells will be infused intravenously.
DRUGFludarabine
D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.
DRUGCyclophosphamide
D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.
Sponsors
UTC Therapeutics Inc.
The Affiliated People's Hospital of Ningbo University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy. 2. Positive expression of specific antigens. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\ 2. 4. Adequate organ functions: * Serum bilirubin ≤ 35 μmol/L; * Serum aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2; * Serum creatinine (Cr) ≤ 2 × upper limit of normal (ULN); * Brain natriuretic peptide (BNP)\<80 pg/mL. 5. 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
1. History of allergy to any of the drugs involved in the protocol. 2. History of cardiac diseases: * Left ventricular ejection fraction (LVEF) \< 50%; * Class III or IV heart failure as defined by the New York Heart Association (NYHA). 3. History of another malignancy tumor. 4. Active hepatitis C (HCV), hepatitis B (HBV), human immunodeficiency virus (HIV), or syphilis infection. 5. Patients with any contraindications to allogeneic hematopoietic stem cell transplantation. 6. Uncontrolled fungal, bacterial, viral, or other infection. 7. Female subjects who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEAEs | 4 weeks | Incidence and severity of Treatment Emergent Adverse Event. |
| TRAEs | 4 weeks | Incidence and severity of Treatment Related Adverse Events. |
| AESIs | 4 weeks | Incidence and severity of AEs of Special Interest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) (PR+CR) | 12 months | The proportion of patients with complete response(CR) or partial response(PR) |
| Progression-Free Survival (PFS) | 12 months | 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. |
| Overall survival (OS) | 12 months | 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. |
Countries
China
Contacts
Primary ContactYing Lu
Backup ContactDong Chen
Outcome results
None listed