Status:
COMPLETED
A PhaseⅠb Study Evaluating Safety and Efficacy of C-CAR011 Treatment in B- NHL Subjects
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Shanghai AbelZeta Ltd.
Conditions:
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 therapy 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 ,Histologically diagnosed as DLBCL,follicular lymphoma and Mantle cell lymphoma according to the NCCN. nonHodgkin's lymphoma Clinical Practice Guidelines (2017 Version 1)
- DLBCL and Follicular Lymphoma (stage Ⅲ-Ⅳ, grade Ⅲb).
- Progressive disease after the last standard chemotherapy regimens.
- Stable disease after the last standard chemotherapy regimens(at least 4 cycles of first-line therapy or 2 cycles of later-line therapy).
- Relapse or progressive disease within 12 months after autologous stem cell transplantation (SCT).
- Follicular lymphoma (stage Ⅲ-Ⅳ) (gradeⅠ-Ⅲa)
- Relapse or progressive disease within 1 year after the last standard chemotherapy regimens(At least 2 combination chemotherapy regimens).
- Stable disease after the last standard chemotherapy regimens(at least 2 cycles of combination chemotherapy regimens).
- 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(at least 4 cycles of first-line therapy or 2 cycles of later- line therapy).
- 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 ≥ 1.5cm).
- 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.
- 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 :
March 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03483688
Start Date
March 6 2018
End Date
January 10 2020
Last Update
March 5 2020
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100010