Overview
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.
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.
Eligibility
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