A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

B Cell Lymphoma Clinical Trial

Official title:

A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036019
• Other study ID #: 0504-009
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2019
• Est. completion date: June 20, 2022

Study information

• Verified date: July 2019
• Source: Shanghai Tongji Hospital, Tongji University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.

Description:

This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection. The study will include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. The patient volunteered to participate in the study, and signed the Informed Consent

2. Age 18-70 years old, male or female

3. Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi= 1.5 cm)

4. r/r lymphoma patients who received prior CD19 CAR-T therapy

5. At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis

6. No immunosuppressive therapy was used within 1 week before C-CAR066 infusion

7. No mAb treatment within 2 weeks before C-CAR066 infusion

8. Adequate organ and bone marrow function

9. No contraindications of apheresis

10. Expected survival time > 3 months

11. ECOG scores 0-1

Exclusion Criteria:

1. Have a history of allergy to cellular products

2. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard

3. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease

4. Patients with active CNS involvement

5. Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor

6. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed

7. Live vaccination within 4 weeks before apheresis

8. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers

9. Have a history of alcoholism, drug addiction and mental illness

10. Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception

11. Patients with severe fludarabine or cyclophosphamide hypersensitivity

12. The patient has a history of other primary cancers, except for the following:

1. Non-melanoma such as skin basal cell carcinoma cured by resection

2. Cured carcinoma in situ such as cervical, bladder or breast cancer

13. The investigators believe that there are other circumstances that are not suitable for the trial

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Biological:
• CD20-directed CAR-T cells
Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously

Locations

Country	Name	City	State
China	Shanghai Tongji Hospital, Tongji University School of Medicine	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Tongji Hospital, Tongji University School of Medicine	Cellular Biomedicine Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	The incidence of treatment-emergent adverse events (TEAEs)	Up to 12 weeks after C-CAR066 infusion
Secondary	Objective response rate (ORR)	The percentage of subjects who achieved complete response and partial response	Up to 24 months after C-CAR066 infusion
Secondary	Complete response rate (CRR)	The percentage of subjects who achieved complete response	Up to 24 months after C-CAR066 infusion
Secondary	Duration of response (DOR)	The time from the date of first response (PR or CR) to the date of disease progression or death after C-CAR066 infusion	Up to 24 months after C-CAR066 infusion
Secondary	Progression free survival (PFS)	The time from C-CAR066 infusion to the date of progression as assessed by Lugano 2014 criteria or death	Up to 24 months after C-CAR066 infusion
Secondary	Overall survival (OS)	Time from C-CAR066 infusion to death from any cause	Up to 24 months after C-CAR066 infusion