Anti-CD19 Chimeric Antigen Receptor (CAR)-Transduced T Cell Therapy for Patients With B Cell Malignancies

• Register: ClinicalTrials.gov
• Last refreshed on: 15 August 2016
• Main ID: NCT02456350
• Date of registration: 12/05/2015
• Prospective Registration: No
• Primary sponsor: Shenzhen Second People's Hospital
• Public title: Anti-CD19 Chimeric Antigen Receptor (CAR)-Transduced T Cell Therapy for Patients With B Cell Malignancies
• Scientific title: Genetically Engineered T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor for Treatment of Patients With B Cell Malignancies
• Date of first enrolment: April 2015
• Target sample size: 36
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02456350
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

China

Contacts

• Name: Mingjun Wang, M.D., Ph.D.

• Name: Mingjun Wang, M.D., Ph.D.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients must have a CD19+ B cell malignancy,including relapsed or refractory B cell
leukemia and B cell lymphoma;

2. Patients with CD19+ B cell malignancies are not able to receive standard treatments
and willing to participate in the trial.

3. Patients must have a measurable or evaluable disease at the time of enrollment, which
may include any evidence of disease including minimal residual disease detected by
flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis;

4. patients are not eligible for autologous or allogeneic stem-cell transplantation
(SCT) or relapsed after autologous or allogeneic stem-cell transplantation;

5. Patients with history of allogeneic stem cell transplantation are eligible, providing
6 months had elapsed from SCT, they have no evidence of active graft-versus-host
disease and no longer taking immunosuppressive agents during the treatment.

6. Willing to sign a durable power of attorney;

7. Able to understand and sign the Informed Consent Document;

8. Performance status:ECOG 0-2;

9. Life expectancy:More than 3 months;

10. Patients of both genders must be willing to practice birth control for four months
after receiving a lymphodepleting preconditioning regimen;

11. Female participants of reproductive potential must have a negative serum or urine
pregnancy test performed within 48 hours before infusion, because of the potentially
dangerous effects on the fetus;

12. There is no obvious dysfunctions in heart , liver and kidney, and the functions of
vital organs are normal;

13. Serology: (1) Seronegative for HIV antibody; (2) Seronegative for hepatitis B virus
(HBV) and hepatitis C virus (HCV).

14. Hematology: (1) Absolute neutrophil count = 1000/mm3 without support of filgrastim;
(2) Platelet count = 50,000/mm3; (3) Hemoglobin > 8.0g/dL; (4) lymphocyte count =
4000/mm3?

15. Chemistry: (1) AST and ALT = 5 times upper limit of normal; (2) Serum creatinine =
1.6 mg/dl; (3) Bilirubin = 1.5 mg/dl(3.0 mg/dL in patients with Gilbert's syndrome)?

16. More than three weeks must have elapsed since any prior systemic therapy at the time
of randomization, and patients' toxicities must have recovered to a grade 1 or less
(except for alopecia or vitiligo);

17. Normal cardiac ejection fraction and no evidence of pericardial effusion as
determined by an echocardiogram;

18?More than 30 days must have elapsed since Monoclonal antibody therapy administered
prior to apheresis.

Exclusion Criteria:

1. Patients that require urgent therapy due to tumor mass effects such as bowel
obstruction or blood vessel compression;

2. Patients that have active hemolytic anemia;

3. Patients with detectable cerebrospinal fluid malignant cells or brain metastases or
with a history of cerebrospinal fluid malignant cells or brain metastases, or any
residual intracranial implants;

4. Women of child-bearing potential who are pregnant or breastfeeding;

5. Active systemic infections, coagulation disorders or other major medical illnesses of
the cardiovascular, respiratory or immune system;

6. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency
Disease);

7. Concurrent opportunistic infections;

8. Concurrent Systemic steroid therapy;

9. History of severe immediate hypersensitivity reaction to any of the agents used in
this study;

10. Patients with central nervous system (CNS) metastases or symptomatic CNS involvement
(including cranial neuropathies or mass lesions);

11. CNS-3 disease or traumatic spinal tap with POSITIVE Steinherz/Bleyer algorithm with
cerebral spinal fluid involvement with malignancy will make any patient not eligible
for this protocol;

12. Patients with cardiac atrial or cardiac ventricular lymphoma involvement;

13. Other anti-neoplastic investigational agents currently or within 30 days prior to
start of the treatment;

14. Previous treatment with any gene therapy products.



Age minimum: 1 Year
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoma

Acute Lymphocytic Leukemia

Chronic Lymphocytic Leukemia

Intervention(s)

Biological: Anti-CD19-CAR transduced T cells

Drug: Fludarabine

Drug: Cyclophosphamide

Primary Outcome(s)

Number of participants with Adverse Events [Time Frame: 8 weeks]

Secondary Outcome(s)

Number of participants with Clinical responses [Time Frame: 2 years]

Secondary ID(s)

201504001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Shenzhen institute for innovation and translational medicine