Actively Recruiting
A Preliminary Study to Evaluate the Safety, Tolerability, Preliminary Efficacy and Pharmacokinetic Profile of KQ-2002 (CD19/CD22 CAR-T) in Adults With Recurrent or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Led by Rong Tao · Updated on 2024-06-06
48
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
Sponsors
R
Rong Tao
Lead Sponsor
N
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and preliminary effectiveness of anti-CD19/CD22 CAR T cells called KQ-2002 in adults with relapsed or refractory CD19-positive B cell acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL). This early-phase study aims to understand how these engineered immune cells work in patients who have not responded to previous treatments or have relapsed. Participants will first undergo screening and leukapheresis to collect cells. They will then receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide over three days to prepare their body for the CAR T cell infusion. The KQ-2002 CAR T cells are infused between two to seven days after chemotherapy ends. The study includes dose escalation and dose expansion phases, testing different cell doses to determine safety and best dosing. During the study, participants will be closely monitored through physical exams, laboratory tests, and assessments for side effects. They will be followed for two years after the CAR T cell infusion to evaluate treatment responses and safety, with extended monitoring for up to 15 years to check for long-term effects. The main outcomes include the incidence of serious toxicities within 28 days and adverse events over the long term.
CONDITIONS
Brief Title
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 18 years old or older
- Histologically confirmed diagnosis of B-cell acute lymphoblastic leukemia or B-cell non-Hodgkin lymphoma meeting specified relapse or refractory conditions
- ECOG performance status of 0 to 2
- Estimated survival time of 12 weeks or more
- Adequate function of main tissues and organs
You will not qualify if you...
- Prior treatment with bendamustine, fludarabine, anti-T-cell monoclonal antibodies, donor lymphocyte infusion, or CNS radiotherapy within specified time frames
- Recent chemotherapy, lenalidomide, bortezomib, vincristine, or glucocorticoids within specified days
- Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection
- Uncontrolled illnesses including severe heart failure, severe arrhythmia, hepatic, renal, metabolic disorders, or uncontrolled hypertension
- Active bleeding or venous thromboembolic events
- Autoimmune diseases causing end-organ damage or requiring systemic immunosuppressants
- Central nervous system disease or symptoms
- Pregnant or nursing women
- Grade 2 or higher non-hematologic toxicity (except alopecia and grade 2 neuropathy)
- Any condition deemed inappropriate by the principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo leukapheresis to collect cells for CAR-T cell preparation.
1 visit (in-person)
Duration - 3 days
Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide to prepare the body for CAR-T cell infusion.
3 consecutive days of intravenous chemotherapy visits
Duration - 1 day
Participants receive infusion of CD19/CD22 CAR-T cells following chemotherapy.
1 infusion visit between 2 to 7 days after chemotherapy
Duration - Up to 15 years
Participants are followed for up to 2 years to monitor response and potential side effects, with long-term monitoring up to 15 years for late effects of cell therapy.
Regular follow-up visits during the first 2 years, then extended monitoring visits
Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital of Nanchang University;
Nanchang, Jiangxi, China, 360000
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Weijing Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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