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

B Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156243
• Other study ID #: ICG134-001
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: January 2019
• Source: iCell Gene Therapeutics
• Contact: Kevin Pinz
• Phone: 6315386218
• Email: kevin.pinz[@]icellgene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• B Cell Leukemia
• B Cell Lymphoma
• Leukemia, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell

Intervention

Biological:
• CD19 CARvac T cells
CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

Locations

Country	Name	City	State
China	The General Hospital of Western Theater Command	Chengdu
China	Peking University Shenzhen Hospital	Shenzhen

Sponsors (4)

Lead Sponsor	Collaborator
iCell Gene Therapeutics	Chengdu Military General Hospital, iCAR Bio Therapeutics Ltd, Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Type of dose-limiting toxicity (DLT)		28 days
Primary	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	Overall Response Rate (ORR)	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	1 year
Secondary	Progression-free survival (PFS)		1 year
Secondary	Overall survival		1 year