Safety and Efficacy of ThisCART19 in Patients With Refractory or Relapsed B Cell Malignancies

B Cell Malignancy Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384393
• Other study ID #: ThisCART19
• Status: Recruiting
• Phase: Phase 1
• Start date: May 9, 2020
• Est. completion date: October 24, 2023

Study information

• Verified date: December 2021
• Source: Fundamenta Therapeutics, Ltd.
• Contact: Jun Li, Ph.D
• Phone: +86-18662604088
• Email: jli[@]ctigen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 24, 2023
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• B Cell Malignancy
• Neoplasms

Intervention

Biological:
• ThisCART19 cells
0.2-60 x 10^6 CAR T cells per kg body weight.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of USTC (Anhui Provincial Hospital)	Hefei	Anhui
China	Fundamenta Therapeutice Co.,Ltd	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Fundamenta Therapeutics, Ltd.	Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose Limiting Toxicities	To assess adverse events as dose limiting toxicities as defined by the protocol.	From infusion to Day 28
Primary	Complete Remission	Proportion of patients in whom with morphologic complete remission (CR)	At Day 28 after ThisCART19 infusion
Primary	TRM: Treatment Related Mortality	The mortality related with ThisCART19 infusion.	Up to 2 years
Secondary	Objective Response Rate	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).	Up to 1 year
Secondary	Duration of Response	Duration of Response (DOR) defined as the duration (days) from initial response to disease relapse, progression, or death due to any course.	Up to 1 year
Secondary	Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability	Adverse events assessed according to NCI-CTCAE v5.0 criteria	From inclusion up to 1 year
Secondary	Overall Survival Rate of 2 Years	The rate of patients whom alive at year 2	At year 2