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

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

Study Overview

• Status: Recruiting
• Conditions: T-cell Acute Lymphoblastic Leukemia; T-cell Non-Hodgkin Lymphoma; T-cell Acute Lymphoblastic Lymphoma
• Intervention / Treatment: Biological: CD7 CAR T cells

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yupo Ma, MD/PhD; Phone Number: 7024658132; Email: yupo.ma@icellgene.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Peking University Shenzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anti-CD7 CAR T cells; anti-CD7 CAR T cells Dose escalation phase: anti-CD7 CAR T cells transduced with a lentiviral vector to express CD7 chimeric receptor domain on T cells with an escalation approach, 1 e6 to 5 e6 CAR-T cells/kg.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Type of dose-limiting toxicity (DLT)	Type of dose-limiting toxicity (DLT)	The first 28 days after infusion
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival	1 year
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
Progression-free survival (PFS)	Progression-free survival (PFS)	1 year

Collaborators and Investigators

• Sponsor: iCell Gene Therapeutics
• Collaborators: Peking University Shenzhen Hospital; iCAR Bio Therapeutics Ltd.
• Investigators: Principal Investigator: Hongyu Zhang, Peking University Shenzhen Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: June 19, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 19, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: T-ALL; T-cell acute lymphoblastic lymphoma; T-cell acute lymphoblastic leukemia; CD7CAR; Anti-CD7 CAR; T cell leukoma/lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia; Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, T-Cell; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: ICG177-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No