B Cell Malignancy
Conditions
Brief summary
This is a study to evaluate the safety and clinical activity of ThisCART19 (Allogeneic CAR-T targeting CD19) in patients with refractory or relapsed CD19 positive B cell malignancies.
Detailed description
This is a single-center, nonrandomized, open-label study to evaluate the safety and clinical activity of ThisCART19 in patients with refractory or relapsed CD19 positive B cell malignancies, such as acute or chronic lymphocytic leukemia, lymphoma and etc. The dose range is 0.2-60 x 10\^6 cells per kg body weight.
Interventions
BIOLOGICALThisCART19 cells
0.2-60 x 10\^6 CAR T cells per kg body weight.
Sponsors
Anhui Provincial Hospital
Fundamenta Therapeutics, Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma. 2. No alternative treatment options deemed by investigator. 3. Measurable or detectble disease at time of enrollment. 4. Eastern cooperative oncology group (ECOG) performance status of ≤2. 5. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO). 6. Estimated life expectancy \> 12 weeks deemed by investigator. 7. Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl . 8. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 upper limit of normal (ULN). 9. Informed consent explained to, understood by and signed by patient/guardian.
Exclusion criteria
1. Pregnant or lactating women 2. Uncontrolled infection 3. Active hepatitis B virus or hepatitis C virus infection. 4. Patients who need steroids to control disease. 5. Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days. 6. Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator. 7. History of Human Immunodeficiency Virus (HIV) infection. 8. Patients with active central nervous system (CNS) involvement by malignancy. 9. Patients combine with other disease cause neutrophil count (ANC) \< 750 per microlitre or platelet count (PLT)\< 50,000 per microlitre.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission | At Day 28 after ThisCART19 infusion | Proportion of patients in whom with morphologic complete remission (CR) |
| TRM: Treatment Related Mortality | Up to 2 years | The mortality related with ThisCART19 infusion. |
| Incidence of Dose Limiting Toxicities | From infusion to Day 28 | To assess adverse events as dose limiting toxicities as defined by the protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Up to 1 year | For Acute Lymphoblastic Leukemia (ALL), Objective response rate(ORR) is the percentage of patients who achieve CR or chronic lymphocytic leukemia(CRi); for chronic lymphocytic leukemia (CLL) and lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). |
| Overall Survival Rate of 2 Years | At year 2 | The rate of patients whom alive at year 2 |
| Duration of Response | Up to 1 year | Duration of Response (DOR) defined as the duration (days) from initial response to disease relapse, progression, or death due to any course. |
| Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability | From inclusion up to 1 year | Adverse events assessed according to NCI-CTCAE v5.0 criteria |
Countries
China
Contacts
Primary ContactJun Li, Ph.D
Backup ContactLing He
Outcome results
None listed