Clinical trial NCT04384393: Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies
Official title: A Study to Evaluate the Safety and Clinical Activity of Allogeneic Chimeric Antigen Receptor T Cells Targeting CD19 in Patients With Refractory or Relapsed B Cell Malignancies.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: B Cell Malignancy
Lead sponsor: Fundamenta Therapeutics, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Anhui Provincial Hospital
First posted: 2020-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Dose Limiting Toxicities
timeFrame: From infusion to Day 28
measure: Complete Remission
timeFrame: At Day 28 after ThisCART19 infusion
measure: TRM: Treatment Related Mortality
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Up to 1 year
measure: Duration of Response
timeFrame: Up to 1 year
measure: Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
timeFrame: From inclusion up to 1 year
measure: Overall Survival Rate of 2 Years
timeFrame: At year 2
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
state: Anhui
city: Suzhou
country: China
facility: Fundamenta Therapeutice Co.,Ltd
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
name: Xingbing Wang
role: PRINCIPAL_INVESTIGATOR
References: