Clinical Research of CD19 Targeted CAR-T Cell in Relapsed/ Refractory B-ALL

ConditionsAcute Lymphoblastic Leukemia, in Relapse Refractory Acute Lymphoblastic Leukemia

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorChongqing Precision Biotech Co., Ltd

About this trial

This is a single-arm, open-label, dose-escalation phase I clinical study to explore the safety, tolerability, and cytokinetic characteristics of MC-1-50 cell formulation, and to preliminarily observe the efficacy of MC-1-50 cell formulation in subjects with relapsed/refractory CD19-positive B Cell Acute Lymphoblastic Leukemia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;

Age ≥ 18 years old (including threshold), gender not limited;

Refractory B-ALL: Early refractory patients who have not achieved complete remission of bone marrow after two courses of first-line systemic therapy upon initial diagnosis;

Individuals with Philadelphia chromosome positive (Ph+) disease are eligible if they have relapsed/refractory disease despite treatment with at least 2 different tyrosine kinase inhibitors (TKIs); (Note: Except for those who are intolerant to TKI therapy, or have T315i mutations);

Disqualifiers

Isolated extramedullary disease;

Central nervous system abnormalities: defined as CNS-2 and 3 according to NCCN guidelines (note: CNS-2 and 3 can be screened, but must be treated and recovered to CNS-1 before lymphodepleting chemotherapy and infusion);

Transformation of chronic myeloid leukemia to acute biphenotypic leukemia;

Individuals who have received CAR-T therapy or other gene modified cell therapies;

Trial design

Design model

Single group

Treatments tested in this trial

MC-1-50
Biological/Vaccine
A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy

Treatment groups

24 Participants

are divided into 1 treatment group

Group A: MC-1-50Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Dose-limiting toxicity after CD19 CAR-T cell infusion

Time frame

1 month

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute\'s Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

Time frame

1 month

Secondary outcomes

AUCS of MC-1-50 cells [Cell dynamics]

AUCS is defined as the area under the curve in 90 days

Time frame

3 months

CMAX of MC-1-50 cell preparation [Cell dynamics]

CMAX is defined as the highest concentration of MC-1-50 cells expanded in peripheral blood

Time frame

3 months

TMAX of MC-1-50 cell preparation[Cell dynamics]

TMAX is defined as the time to reach the highest concentration

Time frame

3 months

Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]

The clearance degree of CD19-positive B cells in peripheral blood was detected by flow cytometry at the visit points specified in the research protocol

Time frame

3 months

Other outcomes

Objective response rate after MC-1-50 infusion [Long-term Efficacy]

Objective response rate includes CR, CRi

Time frame

2 years

Duration of Response (DOR) after MC-1-50 infusion [Long-term Efficacy]

DOR will be assessed from the first assessment of CR/PR to the first assessment of recurrence or progression of the disease or death from any cause

Time frame

2 years

Progress-free survival(PFS) after MC-1-50 infusion [Long-term Efficacy]

PFS will be assessed from the first MC-1-50 cell infusion to death from any cause or the first assessment of progression

Time frame

2 years

Event-Free survival(EFS) after MC-1-50 infusion [Long-term Efficacy]

EFS will be assessed from the first MC-1-50 cell infusion to death from any cause or Disease progression or Treatment failure

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chongqing Precision Biotech Co., Ltd

Lead sponsor

Ruijin Hospital

Collaborator

Source ClinicalTrials.gov

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