Status:
UNKNOWN
A Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-NHL
Lead Sponsor:
Shanghai AbelZeta Ltd.
Collaborating Sponsors:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Refractory or Relapsed B-cell Non-Hodgkin Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
Detailed Description
The study will include the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), Treatment and Follow-up.
Eligibility Criteria
Inclusion
- Volunteered to participate in this study and signed informed consent
- Age 18-70 years old, male or female
- Relapse or refractory B cell non-Hodgkin's lymphoma
- 1\. Histologically diagnosed as DLBCL (including PMBCL) or follicular lymphoma (grade Ⅲb) according to the NCCN non-Hodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)
- Progressive disease after the last standard chemotherapy regimens per the IWG Response Criteria (1999)
- Stable disease after the last standard chemotherapy regimens (at least 4 cycles of first-line therapy or 2 cycles of later-line therapy) per the IWG Response Criteria (1999)
- Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT)
- 2\. Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)
- At least 2 combination chemotherapy regimens (excluding single agent monoclonal antibody)
- Relapse or progressive disease within 1 year after last chemotherapy regimens
- 3\. Mantle cell lymphoma
- Relapse after 1st CR or persistent disease, and not eligible or appropriate for SCT
- Relapse or progressive disease within 1 year after the last chemotherapy regimens
- Relapse or progressive disease within 12 months after autologous SCT
- All subjects must have received anti-CD20 monoclonal antibody (unless tumor is CD20-negative) and anthracycline-containing chemotherapy regimens according to NCCN non-Hodgkin lymphoma Clinical Practice Guidelines (2017 Version 1)
- At least one measurable lesion per revised IWG Response Criteria (the longest diameter of the tumor ≥ 1.5 cm)
- Expected survival ≥ 12 weeks
- ECOG score 0-1
- Left ventricular ejection fraction (LVEF) ≥ 50% (detected by echocardiography)
- No active pulmonary infections, normal pulmonary function and oxygen saturation ≥ 92% on room air
- At least 2 weeks from receiving previous treatment (radiotherapy or chemotherapy) prior to leukapheresis, or at least 4 weeks from monoclonal antibody therapy prior to CAR T cell therapy
- No contraindications of leukapheresis
- Female subjects in childbearing age, their serum or urine pregnancy test must be negative, and must agree to take effective contraceptive measures during the trial
Exclusion
- History of allergy to cellular products
- Laboratory tests: absolute neutrophil count \< 1.0 × 10\^9 /L, platelet count \< 50 × 10\^9 /L, serum albumin \< 30 g/L, serum bilirubin \> 1.5 ULN, serum creatinine \> ULN, ALT/AST \> 3 ULN
- History of CAR T cell therapy or any other genetically modified T cell therapy
- Relapse after allogeneic hematopoietic stem cell transplantation
- Active infections that require treatment (uncomplicated urinary tract infections and bacterial pharyngitis are allowed), prophylactic antibiotic, antiviral and antifungal treatment are permitted
- Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired or congenital immune deficiency diseases, including but not limited to HIV infection
- Class III or IV heart failure according to the NYHA Heart Failure Classifications
- QT interval prolongation ≥ 450 ms
- History of epilepsy or other central nervous system disorders
- Evidence of CNS lymphoma by head enhancement scan or magnetic resonance imaging
- History of other primary cancers, with the following exceptions
- Excisional non-melanoma (e.g. cutaneous basal cell carcinoma)
- Cured in situ carcinoma (e.g. cervical cancer, bladder cancer, breast cancer)
- Autoimmune diseases that require treatment, immune deficiency diseases or other diseases that require immunosuppressive therapy
- Used of systemic steroids within two weeks (using inhaled steroids is an exception)
- Women who are pregnant or lactating, or who have breeding intent in 6 months
- Participated in any other clinical trial within three months
- Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03299738
Start Date
December 1 2017
End Date
August 1 2019
Last Update
December 19 2017
Active Locations (1)
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1
Department of Lymphoma, Tianjin Medical University Cancer Institute and Hospital
Tianjin, China