CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies

Early Phase 1

• Conditions: B Cell Lymphoma; B Cell Leukemia
• Interventions: Biological: CD19 CARvac T cells

• Registration Number: NCT04156243
• Lead Sponsor: iCell Gene Therapeutics

Brief Summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.

Detailed Description

CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat

Study Timeline

• Study Start: 2018-02-01
• Status Verified: 2019-01
• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-07
• Last Update Submitted: 2019-11-08
• Last Update Posted: 2019-11-12
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Diagnosis based on the World Health Organization (WHO) 2008
2. Patients have exhausted standard therapeutic options
3. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
4. Female must be not pregnant during the study

Exclusion Criteria

1. Prior solid organ transplantation
2. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
3. Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19 CARvac T cells	CD19 CARvac T cells	CD19 CARvac T cells transduced with a lentiviral vector to express

Primary Outcome Measures

Name	Time	Method
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	28 days
Type of dose-limiting toxicity (DLT)	28 days
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	2 years

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	1 year	Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Progression-free survival (PFS)	1 year
Overall survival	1 year

Trial Locations

Locations (2)

The General Hospital of Western Theater Command; 🇨🇳 Chengdu, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, China