CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid Malignancies

• ClinicalTrials.gov Identifier: NCT03121625
• Recruitment Status: Recruiting
• First Posted: April 20, 2017
• Last Update Posted: April 25, 2017
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd.
• Collaborator: Hebei Medical University Fourth Hospital
• Information provided by (Responsible Party): Hebei Senlang Biotechnology Inc., Ltd.

Study Description

Brief Summary:

This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of hematopoietic and lymphoid malignancies. A total of 30 patients are planned to be enrolled over a period of 2 years.

Condition or disease	Intervention/treatment	Phase
Leukemia; Lymphoma	Biological: Autologous CAR-T	Phase 1

Detailed Description:

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many other molecules such as CD22, CD30, CD7, BCMA, CD123, etc. may be potential in developing the corresponding CAR-T cells to treat patients whose tumors expressing those markers. Investigators have developed a high efficient platform for constructing different CARs and preclinical studies have demonstrated effective killing of corresponding target cells. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CAR-T Therapy in Relapsed or Refractory Haematopoietic and Lymphoid Malignancies
• Actual Study Start Date: December 26, 2016
• Estimated Primary Completion Date: December 2018
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Autologous CAR-T cells; Patients will be be treated with autologous CAR-T cells.	Biological: Autologous CAR-T; Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.

Outcome Measures

Primary Outcome Measures :

1. Tumor load [ Time Frame: Up to 24 months ]
   Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

Secondary Outcome Measures :

1. CAR T cell persistence [ Time Frame: Up to 24 months] ]
   CAR T cell persistence will be quantified with flow cytometry and qPCR

Eligibility Criteria

• Ages Eligible for Study: 1 Year to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1.The treat history meeting the following criteria:

1. 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;
2. Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients;
3. 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:

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

Contacts and Locations

Contacts

Contact: Jianqiang Li, PhD & MD; 008615511369555; limmune@gmail.com

Locations

China, Hebei

Hematology Department, Hebei Medical University Fourth Hospital; Recruiting

Shijiazhuang, Hebei, China, 050000

Contact: Lihong Liu, PhD & MD +8613831177920 limmune@gmail.com

Contact: PhD & MD

Principal Investigator: Lihong Liu, PhD & MD

Sub-Investigator: Jianqiang Li, PhD & MD

Sponsors and Collaborators

Hebei Senlang Biotechnology Inc., Ltd.

Hebei Medical University Fourth Hospital

Investigators

• Principal Investigator: Lihong Liu, PhD & MD; Hebei Medical University Fourth Hospital

More Information

• Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
• ClinicalTrials.gov Identifier: NCT03121625
• Other Study ID Numbers: 2016040
• First Posted: April 20, 2017
• Last Update Posted: April 25, 2017
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms