Status:
UNKNOWN
Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies
Lead Sponsor:
Fundamenta Therapeutics, Ltd.
Collaborating Sponsors:
Anhui Provincial Hospital
Conditions:
B Cell Malignancy
Eligibility:
All Genders
3-70 years
Phase:
PHASE1
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 a...
Eligibility Criteria
Inclusion
- Patient with relapsed or refractory CD19 positive acute or chronic lymphocytic leukemia, or lymphoma.
- No alternative treatment options deemed by investigator.
- Measurable or detectble disease at time of enrollment.
- Eastern cooperative oncology group (ECOG) performance status of ≤2.
- Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO).
- Estimated life expectancy \> 12 weeks deemed by investigator.
- Serum creatinine ≤1.6 mg/dl and/or blood urea nitrogen(BUN) ≤ 1.5 mg/dl .
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 5 upper limit of normal (ULN).
- Informed consent explained to, understood by and signed by patient/guardian.
Exclusion
- Pregnant or lactating women
- Uncontrolled infection
- Active hepatitis B virus or hepatitis C virus infection.
- Patients who need steroids to control disease.
- Patients who accepted autologous stem-cell transplantation (ASCT) within 100 days.
- Patients with grade 2-4 graft-versus-host disease (GVHD), or deemed need to manage by investigator.
- History of Human Immunodeficiency Virus (HIV) infection.
- Patients with active central nervous system (CNS) involvement by malignancy.
- Patients combine with other disease cause neutrophil count (ANC) \< 750 per microlitre or platelet count (PLT)\< 50,000 per microlitre.
Key Trial Info
Start Date :
May 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 24 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04384393
Start Date
May 9 2020
End Date
October 24 2023
Last Update
January 11 2022
Active Locations (2)
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1
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
2
Fundamenta Therapeutice Co.,Ltd
Suzhou, Jiangsu, China