Novel Allogenic CD19-targeting CAR-γδT Cell Therapy (QH103E) in r/r NHL
ConditionNon-hodgkin Lymphoma,B Cell
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChinese PLA General Hospital
About this trial
CD19-CAR-γδT cell therapy is a cellular immunotherapy targeting CD19 to perform CAR modification on allogeneic γδT cells. A novel version of the CAR-γδT product by gene editing (QH103E) that has been validated for resistance to alloreactive T cell killing and enhancement of memory efficacy will be used in this study.
This is a single center, prospective, open-label, single-arm, phase 1/2 study. A total of around 30 patients with relapsed or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL) will be enrolled in the study and receive QH103E product infusion. Phase 1 (n=9 to 12) is dose escalation part, and phase 2 (n=15 to 20) is expansion cohort part. The primary objective of this study was to evaluate the safety and efficacy of QH103E in patients with r/r B-cell NHL.
Eligibility criteria
Qualifiers
Age 18-75 (inclusive).
Patients with histologically confirmed CD19-positive B-cell NHL.
PD as best response to first-line therapy, or
SD as best response after at least 4 cycles of first-line therapy (eg,4 cycles of R-CHOP), or
Disqualifiers
No obvious hereditary diseases.
Able to understand the requirements and matters of the trial, and willing to participate in clinical research as required.
Informed consent must be signed.
During the screening period, there was central nervous system (CNS) invasion or a history of clinically significant central nervous system diseases, such as epilepsy and cerebrovascular diseases.
Trial design
Treatments tested in this trial
- Allogenic CD19-CAR-γδT cell
- Fludarabine
- Cyclophosphamide
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov