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

Sponsor

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02799550

Collaborator

Chinese PLA General Hospital (Other)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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)

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Biological: allogeneic CART-19	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19

Study Start Date :

Oct 1, 2015

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: allogeneic CART-19 infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)	Biological: allogeneic CART-19 allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

Arm

Intervention/Treatment

Experimental: allogeneic CART-19

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

Biological: allogeneic CART-19

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

Outcome Measures

Primary Outcome Measures

Occurrence of study related adverse events [1 year]
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria

Secondary Outcome Measures

Overall response rate of allogeneic CART-19 [up to 24 weeks]
An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR
Disease-free survival [up to 24 weeks]
Overall survival [up to 24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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