CD7 CAR T-cell for R/R CD7+ T Cell Lymphoma

• Sponsor: The First Affiliated Hospital of Soochow University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05059912
• Collaborator: PersonGen BioTherapeutics (Suzhou) Co., Ltd. (Industry), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), Affiliated Hospital of Jiangnan University (Other), The Affiliated Zhongshan Hospital of Dalian University (Other), The First Affiliated Hospital of Dalian Medical University (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This is a prospective, open-label, multiple center and single arm phase 2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive T cell lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Refractory and Relapsed T Cell Lymphoma	Biological: Humanized CD7 CAR-T cells	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Humanized CD7 CAR T-cell Therapy for R/R CD7+ T Cell Lymphoma
• Actual Study Start Date: Aug 5, 2021
• Anticipated Primary Completion Date: Aug 3, 2023
• Anticipated Study Completion Date: Aug 3, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CD7 positive relapsed or refractory T cell lymphoma Humanized CD7 CAR-T cells intravenously infused to patient with R/R T-NHL[ at a dose of (0.5- 5)x10^6 CD7 CAR-T cells/kg	Biological: Humanized CD7 CAR-T cells; Patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory T cell lymphoma

Outcome Measures

Primary Outcome Measures

1. Overall response rate (ORR) [1 year]

   Number of patients who achieved response (complete response and partial response ) after treatment of CD7 CAR-T cell. Response will be assessed using the Lugano criteria.

2. Number of Adverse Events [1 year]

   Adverse events are evaluated with CTCAE V5.0

Secondary Outcome Measures

1. Complete relapse rate(CR) [1 year]

   Number of patients who achieved complete response after treatment by CD7 CAR-T cell.

2. Duration of overall response (DOR) [1 year]

   Duration of overall response will be assessed from the CAR-T cell infusion to progression, death or last follow-up.

3. Progression-free survival(PFS) [1 year]

   PFS will be assessed from the CAR-T cell infusion to progression, death or last follow-up.

4. Overall survival(OS) [1 year]

   OS will be assessed from the CAR-T cell infusion to death or last follow-up.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥ 18 years

2. R/R T-NHL with measurable (≧1.5cm) lesions confirmed by pathological immunohistochemistry or flow cytometry

3. The expressions of both CD4 and CD8 are negative in patients with bone marrow involved

4. The Eastern Cooperative Oncoloy Group (ECOG) physical condition score ≤ 2 points

5. The main organ functions need to meet the following conditions:

A.Left ventricular ejection fraction ≥50% B.Creatinine ≤132umol/l or creatinine clearance ≥60 ml/min C.ALT and AST≤2.5 upper limitation of normal D.T-BIL≤2.0mg/dl E.SpO2 > 90%

1. Results of pregnant test should be negative, and agree to conception control during treatment and 1 year after CAR-T infusion

2. Expected survival exceeds 3 months

3. Written informed consent could be acquired

Exclusion Criteria:

1. Immunosuppressant medications or steroids were used within 2 weeks before cell collection, or need to use steroids or immunosuppressant medications more than two years

2. Patients with uncontrolled active infection

3. Active hepatitis B or hepatitis C infection

4. Patients with HIV infection

5. Severe acute or chronic graft-versus-host disease (GVHD)

6. Participated in any other drug research clinical trials within 30 days before enrollment

7. Prior CAR-T cells therapy within 3 months before enrollment

8. Prior allogeneic hematopoietic stem cell transplantation within 6 months before enrollment

9. Uncontrolled other tumor

10. Women in pregnancy, lactation or planning to become pregnant

11. The researcher considers inappropriate to participate in this research

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215000

Sponsors and Collaborators

• The First Affiliated Hospital of Soochow University
• PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Affiliated Hospital of Jiangnan University
• The Affiliated Zhongshan Hospital of Dalian University
• The First Affiliated Hospital of Dalian Medical University

Investigators

• Study Chair: Depei Wu, M.D&Ph.D, The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital of Soochow University
• ClinicalTrials.gov Identifier: NCT05059912
• Other Study ID Numbers: CD7T
• First Posted: Sep 28, 2021
• Last Update Posted: Sep 28, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

No Results Posted as of Sep 28, 2021