A Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL

NCT03018093 | Unknown Phase 1 DMC

• 1 other identifier: CBMG2016003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of adult subjects with relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)

Conditions

Relapsed or Refractory Acute Lymphoblastic Leukemia

Keywords

Relapsed or refractory acute lymphoblastic leukemia; Anti-CD19 chimeric antigen receptor T-cell

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  30 days

Secondary Outcomes (3)

• Overall response rate (ORR)

  8 weeks

• Overall survival (OS)

  24 weeks

• Minimal residual disease negative remission rate(MRD-)

  8 weeks

Study Arms (1)

C-CAR011

EXPERIMENTAL

In day 0, 1 and 2, CAR011 cells will be intravenous infused at the 10%, 30% and 60% ratio respectively.

Biological: C-CAR-011

Interventions

C-CAR-011 BIOLOGICAL

CD19-targeted chimeric antigen receptor T cells

Also known as: CAR-CD19

C-CAR011

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 14-75 years old, male or female.
• Volunteered to participate in this study and signed written informed consent form.
• Histologically diagnosed as CD19+B-ALL according to the NCCN Acute Lymphoblastic Leukemia Clinical Practice Guidelines (2016 version 1).
• Relapsed or refractory CD19+B-ALL (meet one of the following conditions)
• Refractory as defined not achieving a CR(complete remission, morphology\<5% blasts) after two cycles of standard chemotherapy regimen.
• Duration of remission ≤ 12 months after the first induction chemotherapy regimen.
• Refractory disease after one or more salvage therapies.
• Two or more Bone Marrow relapse.
• Morphological disease in the bone marrow (≥ 5% blasts).
• Subjects with Philadelphia chromosome negative(Ph-) disease, or subjects with Philadelphia chromosome positive(Ph+) disease that are intolerant to or have failed 2 lines of tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated are eligible.
• No salvage chemotherapy therapy within 4 weeks prior to C-CAR011 therapy.
• No immunosuppressant(including but not limited to systemic corticosteroid therapy) within 4 weeks prior to C-CAR011 therapy.
• No antibody therapy within 4 weeks prior to C-CAR011 therapy.
• Normal cardiac function confirmed by ECHO with left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
• Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.

You may not qualify if:

• History of severe allergic disease or allergic to one or more drugs.
• Any kind of these laboratory testing: serum total bilirubin≧1.5mg/dl, serum albumin≦35g/L, ALT, AST≧2.5×ULN, serum creatinine≧2.0mg/dl, platelets≦50×109/L.
• Extramedullary disease.
• Relapsed disease after allogeneic hematopoietic stem cell transplantation.
• Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis.
• Subjects with concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome or any other known bone marrow failure syndrome.
• Subjects with grade III or above severe hypertension(WHO/ISH Guidelines for the Management of Hypertension, 1999).
• History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months prior to enrollment.
• Subjects with class III and IV heart failure according to the NYHA Heart Failure Classifications;
• History of QT prolongation with clinically significant arrhythmias.
• History of epilepsy or other central nervous system disorders.
• History or presence of any central nervous system leukemia(CNS3, CNS4) disorder , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
• Autoimmune diseases needing treatment, or immune deficiency or other diseases needing immunosuppressive therapy.
• Subjects with TKIs therapy (Ph+ ALL) within 1 week prior to enrollment.
• Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis allowed) or currently receiving intravenous antibiotic therapy and has received intravenous antibiotic therapy within one week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible.

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Li Yu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yu

CONTACT

010-66937644; liyu301@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

CN (1)