Clinical trial NCT04036019: A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: B Cell Lymphoma
Keywords: B cell lymphoma received prior CD19 CAR-T therapy
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai AbelZeta Ltd.
First posted: 2019-07-29
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 12 weeks after C-CAR066 infusion
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 24 months after C-CAR066 infusion
measure: Complete response rate (CRR)
timeFrame: Up to 24 months after C-CAR066 infusion
measure: Duration of response (DOR)
timeFrame: Up to 24 months after C-CAR066 infusion
measure: Progression free survival (PFS)
timeFrame: Up to 24 months after C-CAR066 infusion
measure: Overall survival (OS)
timeFrame: Up to 24 months after C-CAR066 infusion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University School of Medicine
Study officials:
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Aibin Liang, MD,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: