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

Phase 1

• Conditions: Leukemia
• Interventions: Biological: allogeneic CART-19

• Registration Number: NCT02799550
• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

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)

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-05-31
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Status Verified: 2018-06
• Last Update Submitted: 2019-02-21
• Last Update Posted: 2019-02-25
• Primary Completion: 2019-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Overall survival	up to 24 weeks
Disease-free survival	up to 24 weeks

Trial Locations

Locations (2)

Affiliated Hospital of Academy of Military Medical Sciences ,; 🇨🇳 Beijing, Beijing, China

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China