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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-09

Study Completion Date

2023-10-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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B Cell Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ThisCART19 cells injections

In this study, allogeneic anti-CD19 CAR T Cells(ThisCART19 cells) is used to treat patients with refractory or relapsed CD19 positive B cell malignancies.

Group Type EXPERIMENTAL

ThisCART19 cells

Intervention Type BIOLOGICAL

0.2-60 x 10\^6 CAR T cells per kg body weight.

Interventions

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ThisCART19 cells

0.2-60 x 10\^6 CAR T cells per kg body weight.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No