CAR-T Cells in the Treatment of Malignant Hematological Tumors

NCT ID: NCT05619861

Last Updated: 2022-11-17

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

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2023-12-26

Brief Summary

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To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Detailed Description

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Main research objective: To evaluate the safety of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors. Secondary research objective: To investigate the efficacy and cytodynamic characteristics of autologous CAR-T cell injection in the treatment of recurrent and refractory hematopoietic and lymphoid tissue tumors

Conditions

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Lymphoma, B-Cell Leukemia, B-cell Leukemia, T-Cell Multiple Myeloma

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

Autologous CAR-T cells, intravenous infusion, infusion dose 0.1-3 × 106CAR-T cells/kg

Group Type EXPERIMENTAL

CAR-T

Intervention Type BIOLOGICAL

Patients will receive CAR-T treatment

Interventions

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CAR-T

Patients will receive CAR-T treatment

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. With the consent of himself or the legal guardian and the signed informed consent, he is willing and able to comply with the planned visit, research and treatment, laboratory examination and other test procedures; Clinical Study of CAR-T Technique in the Treatment of Recurrent and Refractory Hematopoietic and Lymphatic Tumor
2. Patients with recurrent and refractory hematopoiesis and lymphoid tissue tumors determined by clinical diagnosis;
3. Age 14-70 (including boundary value), both male and female;
4. Subjects with a physical status of 0\~2 in the American Eastern Oncology Collaboration Group (ECOG);
5. The results of treatment related antigens were positive;
6. The expected life span is more than 3 months from the date of signing the informed consent;
Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cangzhou People's Hospital

OTHER

Sponsor Role collaborator

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cangzhou People's Hospital

Cangzhou, Hebei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Rui Zhang

Role: primary

15350769826

Other Identifiers

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2022/11/09

Identifier Type: -

Identifier Source: org_study_id

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