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

NCT ID: NCT04036019

Last Updated: 2024-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-20
• Study Completion Date: 2022-06-20

Brief 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.

Detailed 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.

Conditions

B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

C-CAR066

Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion

Group Type: EXPERIMENTAL

CD20-directed CAR-T cells with CliniMACS Prodigy® system

Intervention Type: BIOLOGICAL

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

Interventions

CD20-directed CAR-T cells with CliniMACS Prodigy® system

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

Intervention Type: BIOLOGICAL

Other Intervention Names

C-CAR066

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role: collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Aibin Liang，MD，Ph.D.

Director，Department of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aibin Liang, MD,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tongji Hospital, Tongji University School of Medicine

Locations

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, , China

Countries

China

References

Li P, Liu W, Zhou L, Ye S, Zhu D, Huang J, Li J, Zheng C, Zhu S, Yao X, Zhu K, Yao Y, Qiu L, Liang A, Zou D. C-CAR066, a novel fully human anti-CD20 CAR-T therapy for relapsed or refractory large B-cell lymphoma after failure of anti-CD19 CAR-T therapy: A phase I clinical study. Am J Hematol. 2024 Dec;99(12):2306-2312. doi: 10.1002/ajh.27488. Epub 2024 Oct 1.

Reference Type: DERIVED

PMID: 39351902 (View on PubMed)

Other Identifiers

0504-009

Identifier Type: -

Identifier Source: org_study_id