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

Diffuse Large 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 Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316624
• Other study ID #: 0502-014
• Status: Completed
• Phase: Phase 1
• Start date: September 29, 2019
• Est. completion date: February 8, 2023

Study information

• Verified date: March 2020
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL 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: 7
• Est. completion date: February 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

2. Age 18-75 years old, male or female

3. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi=1.5 cm)

4. r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20

5. At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis

6. Adequate organ and bone marrow fuction

7. No contraindications of apheresis

8. Expected survival time > 3 months

9. 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 inhibitors

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 peripheral blood 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

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• C-CAR066
Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital	Cellular Biomedicine Group Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 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