CD19-CART Treatment for ALL

Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03232619

Enrollment

Registered

2017-07-28

Start date

2018-08-01

Completion date

2020-09-15

Last updated

2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

Brief summary

This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.

Detailed description

Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.

Interventions

BIOLOGICALCD19 CART

Patients will get one course of CART treatment with the dose of 0.5-5\*10\ 6/KgBW.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Enrolled patients will receive CD19-CART cell immunotherapy.

Eligibility

Sex/Gender

ALL

Age

6 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. previously identified as CD19+ ALL. 2. ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT. 3. Expected survival \>12W. 4. Creatinine \< 2.5 mg/dl. 5. Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal 6. Bilirubin \<2.0 mg/dl 7. Voluntary informed consent is given.

Exclusion criteria

1. Pregnant or lactating women. 2. Uncontrolled active infection. 3. Active hepatitis B or hepatitis C infection. 4. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. 5. Previously treatment with any gene therapy products. 6. Any uncontrolled active medical disorder that would preclude participation as outlined. 7. HIV infection.

Design outcomes

Primary

Measure	Time frame	Description
Radiological assessment	Month1 to Month12	Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.

Secondary

Measure	Time frame	Description
The safety of CART immunotherapy	Day 1 to Week 4	After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026