A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

NCT ID: NCT02349698

Last Updated: 2019-06-25

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

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2023-12-31

Brief Summary

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The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Detailed Description

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Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Conditions

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Leukemia Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19.

Group Type OTHER

Chimeric Antigen Receptor Modified T cells Targeting CD19

Intervention Type BIOLOGICAL

T cells modified with CD19 targeted chimeric antigen receptor.

Chronic Lymphcytic Leukemia

Chronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19.

Group Type OTHER

Chimeric Antigen Receptor Modified T cells Targeting CD19

Intervention Type BIOLOGICAL

T cells modified with CD19 targeted chimeric antigen receptor.

Non-Hodgkin Lymphoma

Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19.

Group Type OTHER

Chimeric Antigen Receptor Modified T cells Targeting CD19

Intervention Type BIOLOGICAL

T cells modified with CD19 targeted chimeric antigen receptor.

Interventions

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Chimeric Antigen Receptor Modified T cells Targeting CD19

T cells modified with CD19 targeted chimeric antigen receptor.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 4 years to 75 years.
5. Disease progresses but reserves reaction to recent treatments.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.

Exclusion Criteria

1. HIV affected.
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. Other situations we think improper for the research.
Minimum Eligible Age

4 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Shiqi Li

Researcher of Biotherpy Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheng Qian, MD, PhD

Role: STUDY_CHAIR

Biotherapy Center of Southwest Hospital

Locations

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Southwest Hospital of Third Millitary Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Cheng Qian, MD,PhD

Role: CONTACT

0086-023-68765461

Zhi Yang, PhD

Role: CONTACT

0086-13206140093

Facility Contacts

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Cheng Qian, PhD

Role: primary

008615086883400

Zhi Yang, PhD

Role: backup

008613206140093

References

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Htun KT, Gong Q, Ma L, Wang P, Tan Y, Wu G, Chen J. Successful Treatment of Refractory and Relapsed CNS Acute Lymphoblastic Leukemia With CD-19 CAR-T Immunotherapy: A Case Report. Front Oncol. 2021 Aug 26;11:699946. doi: 10.3389/fonc.2021.699946. eCollection 2021.

Reference Type DERIVED
PMID: 34513679 (View on PubMed)

Heng G, Jia J, Li S, Fu G, Wang M, Qin D, Li Y, Pei L, Tian X, Zhang J, Wu Y, Xiang S, Wan J, Zhu W, Zhang P, Zhang Q, Peng X, Wang L, Wang P, Wei Z, Zhang Y, Wang G, Chen X, Zhang C, Sun Y, Zhao W, Fan Y, Yang Z, Chen J, Qian C. Sustained Therapeutic Efficacy of Humanized Anti-CD19 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Acute Lymphoblastic Leukemia. Clin Cancer Res. 2020 Apr 1;26(7):1606-1615. doi: 10.1158/1078-0432.CCR-19-1339. Epub 2019 Nov 15.

Reference Type DERIVED
PMID: 31732519 (View on PubMed)

Other Identifiers

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TMMU-BTC-001

Identifier Type: -

Identifier Source: org_study_id

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