CAR-T Cells in Treating Patients With Relapsed or Refractory NHL

Refractory Indolent Adult Non-Hodgkin Lymphoma Clinical Trial

Official title:

An Open, Uncontrolled, Multicenter Clinical Trial to Explore the Safety, Efficacy, and Remission Phase of Chimeric Antigen Receptor T Cell (CAR-T) in the Treatment of Relapsed Refractory (R/R) Non-Hodgkin Lymphoma (NHL)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04626739
• Other study ID #: CAR-T for NHL
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2020
• Est. completion date: March 30, 2023

Study information

• Verified date: November 2020
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Jianqiang Li, Phd&MD
• Phone: 86-311-82970975
• Email: hr[@]senlangbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.

Description:

Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;

2. Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.

To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;

3. There should be at least one measurable tumor focal point;

4. Karnofsky [2] score 50 or more;

5. Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;

6. The expected survival time is greater than 3 months;

7. Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year;

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Refractory Indolent Adult Non-Hodgkin Lymphoma

Intervention

Drug:
• CD19 CAR-T
CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma
• CD22 CAR-T
CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma
• CD19+CD22 CAR-T
CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma
• Fludarabine
25mg/? for D-4?D-3 and D-2
• Cyclophosphamide
500mg/? for D-3 and D-2

Locations

Country	Name	City	State
China	No.2 Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Severe/Adverse Events as a Measure of Safety	Number of Participants with Severe/Adverse Events as a Measure of Safety	28 days
Primary	CAR-T Cell expansion level	Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)	24 months
Secondary	Objective response rate of complete remission and partial remission	Objective response rate of complete remission and partial remission	24 months
Secondary	Overall survival time	Overall survival time	24 months