Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL

NCT ID: NCT02799550

Last Updated: 2019-02-25

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

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2020-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)

Detailed Description

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The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Conditions

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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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allogeneic CART-19

infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

Group Type EXPERIMENTAL

allogeneic CART-19

Intervention Type BIOLOGICAL

allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

Interventions

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allogeneic CART-19

allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 60 years
* Patient with relapsed and/or refractory CD19 positive B-cell acute lymphoblastic leukemia (B-ALL)
* Estimated life expectancy ≥ 12 weeks (according to investigator's judgment)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria

* Previous treatment with investigational gene or cell therapy medicine products
* CD19 negative B-cell leukemia
* Any uncontrolled active medical disorder that would preclude participation as outlined
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huisheng Ai, MD

Role: STUDY_CHAIR

Affiliated Hospital of Academy of Military Medical Sciences

Locations

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Affiliated Hospital of Academy of Military Medical Sciences ,

Beijing, Beijing 100071, China

Site Status RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huisheng Ai, MD

Role: CONTACT

861066947135

Facility Contacts

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Huisheng Ai, MD

Role: primary

86-1066947126

Weidong Han, MD

Role: primary

86-13651392893

References

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Cai B, Guo M, Wang Y, Zhang Y, Yang J, Guo Y, Dai H, Yu C, Sun Q, Qiao J, Hu K, Zuo H, Dong Z, Zhang Z, Feng M, Li B, Sun Y, Liu T, Liu Z, Wang Y, Huang Y, Yao B, Han W, Ai H. Co-infusion of haplo-identical CD19-chimeric antigen receptor T cells and stem cells achieved full donor engraftment in refractory acute lymphoblastic leukemia. J Hematol Oncol. 2016 Nov 25;9(1):131. doi: 10.1186/s13045-016-0357-z.

Reference Type DERIVED
PMID: 27887660 (View on PubMed)

Other Identifiers

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CART-ALL-2015

Identifier Type: -

Identifier Source: org_study_id

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