CAR T Cells for Refractory B Cell Malignancy

Phase 1

• Conditions: B-Cell Leukemia; B-Cell Lymphoma
• Interventions: Biological: Autologous CD19-targeting CAR T cells

• Registration Number: NCT02963038
• Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Brief Summary

Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell malignancy including lymphoma or leukemia.

Detailed Description

The CAR consists of a CD19 targeting antibody scFv with three intracellular signaling domains derived from CD3 zeta, CD28 and 4-1BB. Autologous T cells will be gene engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-10-28
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-15
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-04-28
• Primary Completion: 2017-06
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. The treat history meeting the following criteria:

   • Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation;
   • Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
   • One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.

2. There is a measurable lesions before treatment at least;

3. ECOG score≤2;

4. To be aged 1 to 70 years;

5. More than a month lifetime from the consent signing date

Exclusion Criteria

• Serious cardiac insufficiency, left ventricular ejection fraction<50;
• Has a history of severe pulmonary function damaging;
• Merging other malignant tumor;
• Merging uncontrolled infection;
• Merging the metabolic diseases (except diabetes);
• Merging severe autoimmune diseases or immunodeficiency disease;
• patients with active hepatitis B or hepatitis C;
• patients with HIV infection;
• Has a history of serious allergies on Biological products (including antibiotics);
• Happened in 3 ~ 4 acute GvHD after allogeneic hematopoietic stem cell transplantation on recurring patients Pregnancy or lactation women; Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19 CAR T cells	Autologous CD19-targeting CAR T cells	Autologous CD19-targeting CAR T cells

Primary Outcome Measures

Name	Time	Method
Tumor load	Up to 24 months	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Secondary Outcome Measures

Name	Time	Method
CAR T cell persistence	Up to 24 months	Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis

Trial Locations

Locations (1)

No.2 Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China