Actively Recruiting
Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r/r B-NHL
Led by Chinese PLA General Hospital · Updated on 2024-03-25
30
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The team has developed the synthetic T cell receptor (TCR) and antigen receptor (STAR) T cells which were demonstrated safety in relapsed or refractory (r/r) B-cell non-Hodgkin' s lymphoma (B-NHL) (NCT05631912). Based on this research, allogeneic STAR-T cell products utilized the CRISPR-Cas9 gene editing tool to knock out endogenous receptor α constant (TRAC), human leukocyte antigen (HLA)-A/B, CIITA, and programmed death 1 (PD-1) genes simultaneously in T cells from healthy donors, and integrated the STAR molecule into the TRAC locus using adenovirus associated virus. This strategy can reduce graft-versus-host-disease (GvHD) toxicity and host-versus-graft response, decrease the sensitivity of STAR T cells to immunosuppressive signals, and improve their anti-tumor activity. In this single center, prospective, open-label, single-arm, phase 1/2 study, the safety and efficacy of allogeneic CD19-targeting STAR T cell therapy will be evaluated in patients with r/r B-NHL.
CONDITIONS
Official Title
Allogeneic TRAC Locus-inserted CD19-targeting STAR T Cell Therapy in r/r B-NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years inclusive
- Histologically confirmed CD19-positive B-cell non-Hodgkin's lymphoma, including DLBCL-NOS, PMBCL, TFL, HGBCL, FL, MCL, and MZL
- Relapsed after 2 or more systemic therapies or refractory disease for aggressive lymphoma types
- Adequate prior therapy including anthracycline or bendamustine chemotherapy and anti-CD20 monoclonal antibody (with exceptions for CD20-negative tumors)
- Estimated survival time greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- At least one evaluable tumor focus meeting size criteria by CT or MRI
- Willingness to undergo tumor biopsy or provide tumor tissue samples
- Adequate organ function including heart, kidney, liver, and lung function as specified
- Blood counts meeting specified minimum levels without growth factor support
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception during treatment and for 1 year after
- Toxicity from prior therapies must be grade 1 or less or acceptable according to criteria
- No significant hereditary diseases
- Ability to understand and willing to participate in the study
- Signed informed consent
You will not qualify if you...
- Presence or history of central nervous system invasion or significant CNS diseases such as epilepsy or cerebrovascular disease
- Pregnancy or breastfeeding, or refusal to use contraception during treatment and 1 year after
- History of allogeneic hematopoietic stem cell or organ transplantation
- History of other active malignancies not in remission
- Primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy
- Radiotherapy within 3 months prior to enrollment
- Immunotherapy within 4 weeks prior to enrollment
- Positive anti-CD19 scFv reaction in serum
- Prior CD19-targeted therapy or CAR-T/genetically modified T cell therapy
- Presence of donor-specific antibodies against STAR T cells
- Participation in other clinical trials within 4 weeks prior to enrollment
- Uncontrolled infections or serious illnesses including HIV or active hepatitis
- Uncontrollable serous membrane fluid such as massive pleural effusion or ascites
- Stroke or intracranial hemorrhage within 3 months prior to enrollment
- Major surgery or trauma within 28 days prior or unresolved major side effects
- Allergy to ingredients in cell products
- Mental or physical conditions interfering with study participation or data interpretation
- Investigator judgment that participation poses significant risk or interferes with study
- Inability or unwillingness to provide informed consent
- Other reasons deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Biotherapeutic Department of Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
2
School of medicine, Tsinghua University & Changping Laboratory
Beijing, China
Actively Recruiting
Research Team
W
Weidong Han, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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