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

NCT04036019 | Completed Phase 1

• 1 other identifier: 0504-009
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

B Cell Lymphoma

Keywords

B cell lymphoma received prior CD19 CAR-T therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  The incidence of treatment-emergent adverse events (TEAEs)

  Up to 12 weeks after C-CAR066 infusion

Secondary Outcomes (5)

• Objective response rate (ORR)

  Up to 24 months after C-CAR066 infusion

• Complete response rate (CRR)

  Up to 24 months after C-CAR066 infusion

• Duration of response (DOR)

  Up to 24 months after C-CAR066 infusion

• Progression free survival (PFS)

  Up to 24 months after C-CAR066 infusion

• Overall survival (OS)

  Up to 24 months after C-CAR066 infusion

Study Arms (1)

C-CAR066

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: C-CAR066

C-CAR066

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient volunteered to participate in the study, and signed the Informed Consent
• Age 18-70 years old, male or female
• Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
• r/r lymphoma patients who received prior CD19 CAR-T therapy
• At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
• No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
• No mAb treatment within 2 weeks before C-CAR066 infusion
• Adequate organ and bone marrow function
• No contraindications of apheresis
• Expected survival time \> 3 months
• ECOG scores 0-1

You may not qualify if:

• Have a history of allergy to cellular products
• Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
• A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
• Patients with active CNS involvement
• Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
• Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
• Live vaccination within 4 weeks before apheresis
• HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
• Have a history of alcoholism, drug addiction and mental illness
• 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
• Patients with severe fludarabine or cyclophosphamide hypersensitivity
• The patient has a history of other primary cancers, except for the following:
• Non-melanoma such as skin basal cell carcinoma cured by resection
• Cured carcinoma in situ such as cervical, bladder or breast cancer
• The investigators believe that there are other circumstances that are not suitable for the trial

Sponsors & Collaborators

• Shanghai Tongji Hospital, Tongji University School of Medicine: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai, 200065, China

Location

Related Publications (1)

• 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.

  PMID: 39351902 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Aibin Liang, MD,Ph.D.

  Shanghai Tongji Hospital, Tongji University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director，Department of Hematology

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 29, 2019
• Study Start: August 20, 2019
• Primary Completion: June 20, 2022
• Study Completion: June 20, 2022
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)