Natural Killer (NK) Cell Therapy for B-Cell Malignancies
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma.
This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL. Up to 22-36 patients will be enrolled.
Full description
This is an open-label, Phase I study of QN-019a (allogeneic CAR-NK cells targeting CD19) as monotherapy in relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) and in combination with Rituximab in relapsed/refractory B-cell Lymphoma.
This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-019a in patients with relapsed/refractory B-cell lymphoma or B-ALL, where a "3+3" enrollment schema will be utilized at dose escalation stage. Up to 24-36 patients will be enrolled.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Diagnosis of B-cell lymphoma or B-ALL as described below:
B-cell Lymphoma:
- Histologically documented lymphomas expected to express CD19 and CD20
- Relapsed/refractory disease following at least two prior systemic treatment regimens, or relapsed after the autologous hematopoietic stem cell transplantation (HSCT)
B-ALL:
- Diagnosis of B-ALL that expected to express CD19
- Relapsed/refractory disease following prior systemic treatment regimens
ALL SUBJECTS:
- Provision of signed and dated informed consent form (ICF)
- Age ≥ 18 years old
- Stated willingness to comply with study procedures and duration
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- Adequate organ function as defined in the protocol
- Donor specific antibody (DSA) to QN-019a: MFI <= 2000
- At least 3 weeks after the last systemic immunochemotherapy treatment
- The estimated survival days are expected to be over 3 months
Key Exclusion Criteria:
ALL SUBJECTS:
- Females who are pregnant or lactating
- Evidence of insufficient organ function as defined in the protocol
- ECOG Performance Status ≥2
- Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T/CAR-NK within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
- Currently receiving or likely to require systemic immunosuppressive therapy
- Known active central nervous system (CNS) involvement by malignancy. Non-malignant CNS disease such as stroke, epilepsy, or neurodegenerative disease
- Clinically significant cardiovascular disease as defined in the protocol
- Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection
- Donor specific antibody (DSA) to QN-019a: MFI > 2000
- Other comorbid conditions and concomitant medications prohibited as per study protocol
- Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
Trial design
Primary purpose
Allocation
Interventional model
Masking
24 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
He Huang, PhD; Yongxian Hu, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal