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

Phase 1

• Conditions: B Cell Malignancy

• Registration Number: NCT04384393
• Lead Sponsor: Fundamenta Therapeutics, Ltd.

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.

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-08
• Study Start: 2020-05-09
• Study First Posted: 2020-05-12
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2022-01-11
• Primary Completion: 2022-11-10
• Study Completion: 2023-10-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (2)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital); 🇨🇳 Hefei, Anhui, China

Fundamenta Therapeutice Co.,Ltd; 🇨🇳 Suzhou, Jiangsu, China