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Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation

NCT ID: NCT04626726

Last Updated: 2020-11-13

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

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-05-30

Brief Summary

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This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

Detailed Description

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This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。

Conditions

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Adult B Acute Lymphoblastic Leukemia

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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Volunteers

The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with acute B lymphocytic leukemia expressing specific target antigens

Group Type EXPERIMENTAL

CD19 CAR-T

Intervention Type DRUG

CD19 CAR-T infusion for patients with CD19 positive tumor cells

CD22 CAR-T

Intervention Type DRUG

CD22 CAR-T infusion for patients with CD22 positive tumor cells

CD19+CD22 CAR-T

Intervention Type DRUG

CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells

Fludarabine

Intervention Type DRUG

25mg/㎡ for D-4、D-3 and D-2

Cyclophosphamide

Intervention Type DRUG

500mg/㎡ for D-3 and D-2

Interventions

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CD19 CAR-T

CD19 CAR-T infusion for patients with CD19 positive tumor cells

Intervention Type DRUG

CD22 CAR-T

CD22 CAR-T infusion for patients with CD22 positive tumor cells

Intervention Type DRUG

CD19+CD22 CAR-T

CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells

Intervention Type DRUG

Fludarabine

25mg/㎡ for D-4、D-3 and D-2

Intervention Type DRUG

Cyclophosphamide

500mg/㎡ for D-3 and D-2

Intervention Type DRUG

Other Intervention Names

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Senl_19 Senl_22 Senl_19+22 fiu ctx

Eligibility Criteria

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Inclusion Criteria

1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
2. ECOG score≤2;
3. To be aged 1 to 65 years;
4. More than a month lifetime from the consent signing date.

Exclusion Criteria

1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%;
2. Has a history of severe pulmonary function damaging;
3. Merging other progressing malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C;
8. Patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
11. Pregnancy or lactation women;
12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianmin Luo, PhD&MD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Locations

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No.2 Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianqiang Li, PhD&MD

Role: CONTACT

Phone: +8631189928689

Email: [email protected]

Facility Contacts

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Jianqiang Li, PhD & MD

Role: primary

Jianmin Luo, PhD & MD

Role: backup

Other Identifiers

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CAR-T for adult B-ALL

Identifier Type: -

Identifier Source: org_study_id