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

NCT04626739 | Unknown Early Phase 1

• 1 other identifier: CAR-T for NHL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Refractory Indolent Adult Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

• CAR-T Cell expansion level

  Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM)

  24 months

Secondary Outcomes (2)

• Objective response rate of complete remission and partial remission

  24 months

• Overall survival time

  24 months

Study Arms (1)

volunteers

EXPERIMENTAL

The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma

Drug: CD19 CAR-T; Drug: CD22 CAR-T; Drug: CD19+CD22 CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

CD19 CAR-T DRUG

CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma

Also known as: Senl_19

volunteers

CD22 CAR-T DRUG

CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma

Also known as: Senl_22

volunteers

CD19+CD22 CAR-T DRUG

CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma

Also known as: Senl_19+22

volunteers

Fludarabine DRUG

25mg/㎡ for D-4、D-3 and D-2

Also known as: flu

volunteers

Cyclophosphamide DRUG

500mg/㎡ for D-3 and D-2

Also known as: ctx

volunteers

Eligibility Criteria

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

You may qualify if:

• 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;
• 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;
• There should be at least one measurable tumor focal point;
• Karnofsky \[2\] score 50 or more;
• Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;
• The expected survival time is greater than 3 months;
• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

No.2 Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

MeSH Terms

Interventions

fludarabine; Influenza Vaccines; Cyclophosphamide; Cholestanetriol 26-Monooxygenase

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cytochrome P450 Family 27; Cytochrome P-450 Enzyme System; Cytochromes; Enzymes and Coenzymes; Steroid Hydroxylases; Mixed Function Oxygenases; Oxygenases; Oxidoreductases; Enzymes; Hemeproteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Jianmin luo, PhD&MD

  The Second Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianqiang Li, Phd&MD

CONTACT

86-311-82970975; hr@senlangbio.com

Study Design

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

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 13, 2020
• Study Start: April 1, 2020
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)