Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients
Clinical Study to Evaluate the Safety and Efficacy of IM19 CAR-T Cell Therapy in Patients With Relapsed or Refractory CD19-positive Non-Hodgkin's Lymphoma
1 other identifier
interventional
30
1 country
1
Brief Summary
n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2018
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2018
CompletedFirst Posted
Study publicly available on registry
May 17, 2018
CompletedStudy Start
First participant enrolled
May 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedJuly 16, 2018
May 1, 2018
1.9 years
May 7, 2018
July 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of study related adverse events
\>= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2.
2 years
Secondary Outcomes (1)
Overall response rate
2 years
Study Arms (1)
IM19 CAR-T cells
EXPERIMENTAL3\*10\^5/kg，1\*10\^6/kg，3\*10\^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days
Interventions
Two days before cell infusion, all patients will be treated with fludarabine for 3 days
Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
Eligibility Criteria
You may qualify if:
- Relapsed or refractory CD19-positive non-Hodgkin lymphoma (NHL) patients. 1 Diffuse large B lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL) patients meet one of the following conditions: I Patients who have relapsed or are refractory after at least 2 previous treatments; II Patients who have relapsed after transplantation. 2 Patients with relapsed or refractory mantle cell lymphoma after at least one treatment.
- Patients must have evaluable disease evidence;
- Age ≥ 18 years old;
- The expected life span is more than 3 months;
- ECOG score 0-2 points (see Attachment 2);
- Women of childbearing age have a negative blood pregnancy test before the start of the trial and agree to have effective contraceptive measures during the trial until the last follow-up;
- Those who voluntarily participate in the trial and sign the informed consent.
You may not qualify if:
- Patients with high-risk organ involvement: tumors invade one of the central nervous system, gastrointestinal tract, lungs, pericardium, and large vessels;
- Those who have a graft-versus-host response and need to use immunosuppressive drugs; or who have a disease of the autoimmune system;
- Use chemotherapy or radiotherapy within 3 days before the blood collection period;
- Those who have used systemic steroids within the 5 days prior to the blood sampling period (except recently or currently using inhaled steroids);
- Use stimulating bone marrow hematopoietic cells to produce drugs (whitening needles, etc.) within 5 days before the blood collection period;
- Those who have previously used any gene therapy products;
- History of epilepsy or other diseases of the central nervous system;
- New York Heart Association (NYHA) class III or above (see Annex 3);
- creatinine\> 1.5 times the upper limit of normal or ALT / AST\> 3 times the upper limit of normal or bilirubin\> 2 times the normal upper limit;
- active Hepatitis B or Hepatitis C virus, HIV or other untreated active infections;
- pregnant or lactating women;
- suffer from other uncontrolled diseases that the researcher considers inappropriate;
- Any condition that the investigator believes may increase the subject's risk or interfere with the test results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Related Publications (2)
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PMID: 34515338DERIVEDYing Z, He T, Wang X, Zheng W, Lin N, Tu M, Xie Y, Ping L, Zhang C, Liu W, Deng L, Wu M, Feng F, Leng X, Du T, Qi F, Hu X, Ding Y, Lu XA, Song Y, Zhu J. Distribution of chimeric antigen receptor-modified T cells against CD19 in B-cell malignancies. BMC Cancer. 2021 Feb 25;21(1):198. doi: 10.1186/s12885-021-07934-1.
PMID: 33632155DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2018
First Posted
May 17, 2018
Study Start
May 22, 2018
Primary Completion
April 1, 2020
Study Completion
May 1, 2020
Last Updated
July 16, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share