Trial | NCT04316624  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    7
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.
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.
Study Started
Sep 29
2019
Primary Completion
Feb 08
2023
Study Completion
Feb 08
2023
Last Update
Jul 19
2023

Drug C-CAR066

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

C-CAR066 Experimental

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

Criteria 

Inclusion Criteria:

The patient volunteered to participate in the study, and signed the Informed Consent
Age 18-75 years old, male or female
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)
r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
Adequate organ and bone marrow fuction
No contraindications of apheresis
Expected survival time > 3 months
ECOG scores 0 - 1

Exclusion Criteria:

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 inhibitors
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 peripheral blood 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
No Results Posted