Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances

T-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:

Non-gene Edited Anti-CD7 CAR T Cells for Relapsed/Refractory T Cell Malignances

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934774
• Other study ID #: ICG177-001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2021
• Source: iCell Gene Therapeutics
• Contact: Kevin Pinz, MS
• 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 non-gene edited anti-CD7 CAR (also called anti-CD7 CAR) T cells in patients with relapsed and/or refractory T cell lymphoma or leukemia

Description:

Anti-CD7 CAR is a chimeric antigen receptor immunotherapy treatment designed to treat leukemia/lymphoma expressing CD7 antigen. T-cell acute lymphoblastic leukemia, T-acute lymphoblastic lymphoma and T-cell non-Hodgkin lymphoma are a subset of leukemias and lymphomas that are positive for the surface protein CD7. The purpose of this study is to evaluate the efficacy and safety of anti-CD7 CAR T cells.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Signed written informed consent; Patients volunteer to participate in the research

2. Diagnosis is mainly based on the World Health Organization (WHO) 2008

3. Patients have exhausted standard therapeutic options

4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 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. Any drug used for GVHD must be stopped >1 week

Related Conditions & MeSH terms

• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, T-Cell
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• T-cell Acute Lymphoblastic Leukemia
• T-cell Acute Lymphoblastic Lymphoma
• T-cell Non-Hodgkin Lymphoma

Intervention

Biological:
• CD7 CAR T cells
Non-gene edited anti-CD7 CAR 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	Peking University Shenzhen Hospital	Shenzhen	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
iCell Gene Therapeutics	iCAR Bio Therapeutics Ltd., Peking University Shenzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)	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	The first 28 days after infusion
Primary	Type of dose-limiting toxicity (DLT)	Type of dose-limiting toxicity (DLT)	The first 28 days after infusion
Primary	Adverse event by severity	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 of ant-CD7 CAR	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)	Progression-free survival (PFS)	1 year
Secondary	Overall survival	Overall survival	1 year