Natural Killer (NK) Cell Therapy for B-Cell Malignancies

Sponsor
Zhejiang University
Study ID
NCT05379647
Phase
PHASE1
Status
Unknown

Conditions

  • B-cell Acute Lymphoblastic Leukemia
  • B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QN-019a — DRUG
    Experimental Interventional Therapy
  • Rituximab — DRUG
    Monoclonal Antibody
  • Cyclophosphamid — DRUG
    Lympho-conditioning Agent
  • Fludarabine — DRUG
    Lympho-conditioning Agent
  • VP-16 — DRUG
    Lympho-conditioning Agent

Study Details

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.

Key Dates

Start date
Nov 4, 2021
Status verified
May 2022
Primary completion
Jun 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: QN-019a in Combination with Monoclonal Antibodies
    QN-019a in Combination with Rituximab in adult subjects with r/r B-cell lymphoma.
  • Experimental: QN-019a Monotherapy
    QN-019a Monotherapy in adult subjects with r/r B-ALL

Primary Outcome Measure

The incidence of subjects with Dose Limiting Toxicities within each dose level cohort [ Time Frame: Day 28 ]

Central Contacts

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