CD20-CD19 Compound CAR (cCAR) 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 CD20-CD19 cCAR in Patients With Relapsed and/or Refractory B Cell Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156178
• Other study ID #: ICG133-001
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 1, 2018
• Est. completion date: September 30, 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 CD20-CD19 cCAR in patients with relapsed and/or refractory B cell malignancies.

Description:

Clinical trials with CD19-directed CARs have achieved unprecedented remission rates as high as 90%. However, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. CD20-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CD20 and CD19. CD20-CD19 cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 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. Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL

3. Patients have exhausted standard therapeutic options

4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks

5. Female must be not pregnant during the study

Exclusion Criteria:

1. Patients declining to consent for treatment

2. Prior solid organ transplantation

3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant

4. Prior treatment with CD20xCD3 or CD19x3 bispecific agents

Related Conditions & MeSH terms

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

Intervention

Biological:
• CD20-CD19 cCAR T cells
CD20-CD19 cCAR 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	Chengdu Military General Hospital	Chengdu
China	Peking University Shenzhen Hospital	Shanghai

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