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Sequential Infusion of CD19 and BCMA CAR-T Cells to Improve PTR in Patients With AL

NCT ID: NCT04846439

Last Updated: 2021-10-27

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/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-29

Study Completion Date

2024-03-31

Brief Summary

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Alloimmune-mediated platelet transfusion refractoriness(PTR) was usually caused by repeated blood transfusions and pregnancy and accounts for about 20-25% of PTR patients. Patients with acute leukemia need repeated platelet infusion in myelosuppression period after chemotherapy, and PTR incidence is more higher.PTR was associated with adverse events,including longer hospital stays,severe hemorrhages and an increased risk of early deaths and may have a negative impact on the success of HSCT. The current management of patients with PTR includes specific transfusion strategies, IVIG, rituximab,thrombopoietin-receptor agonists(TPO-RA) ,bortezomib or splenectomy,have been largely unsatisfactory. As we know, HLA antibodies are mainly secreted by the plasma cells. Researchers want to see if sequential infusion of CD19 and BCMA CAR-T cells can clear the B cells and plasma cells, can help increase platelet levels and reduce bleeding in patients with platelet transfusion refractoriness. To see if sequential infusion can increases platelet levels more after a transfusion. To see if it reduces the chance of bleeding. Adults 16-65 years old who diagnosed with acute leukemia in CR and alloimmune platelet transfusion refractoriness.

Detailed Description

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The patients will receive infusion of CAR T-cells targeting CD19 and BCMA to confirm the safety and efficacy of CD19 and BCMA CAR T-Cells Sequential infusion in acute leukemia with alloimmune-mediated platelet transfusion refractoriness.

Conditions

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Platelet Transfusion Refractoriness Acute Leukemia in Remission

Keywords

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CAR-T alloimmune platelet transfusion refractoriness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAR-T infusion

CD19 and BCMA CAR-T cells were infused into complete remission acute leukemia patients with PTR sequentially, with（1.0-2.0）×10e7/kg respectively. Each patient was followed up for 1 years.

Group Type EXPERIMENTAL

CAR-T infusion

Intervention Type BIOLOGICAL

Sequential infusion of CD19 and BCMA autologous chimeric antigen receptor T cells, the infusion dose was determined according to the body weight of the subject and the effective content of cell preparation.

Interventions

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CAR-T infusion

Sequential infusion of CD19 and BCMA autologous chimeric antigen receptor T cells, the infusion dose was determined according to the body weight of the subject and the effective content of cell preparation.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Ages 16-65 years inclusive.
* Ability to comprehend the investigational nature of the study and provide informed consent.
* Expected survival time ≥ 3 months (according to investigator's judgement)
* Acute leukemia in complete remission diagnosed with alloimmune-mediated PTR, characterized by all of the following:

Lack of adequate post-transfusion platelet count increment, defined by CCI \<7500/μl at 10-60 min, and CCI \<5000/μl at 18-24 hrs (in those who had a CCI at 10-60 min greater than or equal to 5000/μl) after at least 2 consecutive transfusions.

Presence of anti-HLA class A and/or B antibody.

* Left ventricular ejection fractions ≥ 0.5 by echocardiography.
* Creatinine \< 1.6 mg/dL.
* Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
* Total bilirubin \<2.0 mg/dL.
* karnofsky performance status ≥ 60.

Exclusion Criteria

* PTR induced by other reasons(eg:DIC,fever,infection and splenomegaly)
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection
* Patients with HIV or syphilis infection
* Patients are pregnant or lactating
* Patients has a history of allo-HSCT
* Alloimmune-mediated PTR responsive to treatment with plasma exchange
* Alloimmune-mediated PTR responsive to treatment with rituximab or IVIG
* Grade III/IV cardiovascular disability according to the New York Heart Association Classification
* Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second People's Hospital of Huai'an

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd

INDUSTRY

Sponsor Role collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haiping Dai, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

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The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaowen Tang, Ph.D

Role: CONTACT

Phone: (0086)51267781856

Email: [email protected]

Facility Contacts

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xiaowen tang, Ph.D

Role: primary

Other Identifiers

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2021062

Identifier Type: -

Identifier Source: org_study_id