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Trial Title:
CD19/CD22 CAR-T Cells in Adults With R/R ALL or NHL
NCT ID:
NCT06445803
Condition:
Acute Lymphoblastic Leukemia, in Relapse
Acute Lymphoblastic Leukemia With Failed Remission
B-cell Lymphoma Refractory
B-cell Lymphoma Recurrent
Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Lymphoma, B-Cell
Conditions: Keywords:
CAR-T therapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
KQ-2002 CAR-T cells （CD19/CD22 CAR T-Cells）
Description:
CD19/CD22 cells will be infused on Day1 after induction chemotherapy regimen.
Lymphodepleting chemotherapy:3 days of IV chemotherapy with fludarabine and
cyclophosphamide.
Fludarabine 30 mg/m2/day IV x 4 days (days -5 through -3) Cyclophosphamide 500 mg/m2/day
IV x 2 days (days -5 and-3)
Arm group label:
Dose escalation
Arm group label:
Dose expansion
Summary:
This study examines the safety, tolerability and preliminary efficacy of anti-CD19 /CD22
CAR T cells (KQ-2002)manufactured on-site in adults with relapsed or refractory CD19+ B
cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma.
Detailed description:
Patients will undergo screening, leukapheresis (cell collection), lymphodepleting
chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 KQ-2002 CAR
T cell infusion. The lymphodepleting chemotherapy is administered over 3 days IV to
prepare the body for the CAR T cells. The CAR-T cells are infused between 2-7 days after
the last dose of chemotherapy. Patients will be followed for two years after the cell
infusion on the study and for up to 15 years to monitor for potential long term side
effects of cell therapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female,≥18 years old;
- Histologically confirmed diagnosis of B-ALL or B-NHL(meeting one of the following
conditions):
(B-NHL)
1. Second or greater relapse (CD20 regimens must be included) OR
2. Refractory to first-line chemotherapy or relapse within 1 year OR
3. Relapse within 1 year of auto-HSCT.
4. With measurable or evaluable lesions（Dose expansion cohort） (B-ALL)
a. Relapse within 12 months of complete remission on first treatment OR b. Relapse after
second-line treatment OR c. Relapse after auto HST OR d. Failure to achieve CR/CRi at the
end of induction therapy OR e. Ph+ ALL intolerance to TKI or refractory or relapse after
treatment with at least two and more TKIs.
- ECOG 0~2
- Estimated survival time ≥ 12 weeks;
- Main tissues and organs function well.
Exclusion Criteria:
- Subjects will be excluded related to the following prior therapy criteria:Prior
treatment with bendamustine-containing or fludarabine;Anti-T-cell monoclonal
antibody, donor lymphocyte infusion, and CNS radiotherapy within 8 weeks;
Chemotherapy, lenalidomide, bortezomib within 2 weeks; vincristine within 1 week;
glucocorticoids (prednisone ≥7.5 mg/d or equivalent) within 72 h
- Active or latent hepatitis B or active hepatitis C (test within 8 weeks of
screening), or any uncontrolled infection at screening
- Uncontrolled, symptomatic, intercurrent illness including but not limited to angina
pectoris, cerebrovascular accident or transient ischemia (within 6 months prior to
screening), myocardial infarction (within 6 months prior to screening), New York
Heart Association (NYHA) classification of ≥ Class III congestive heart failure,
severe arrhythmia poorly controlled by medications, hepatic, renal, or metabolic
disorders, and hypertension that is uncontrolled by standard therapy；
- active bleeding, or venous thromboembolic event
- Autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus
erythematosus, etc.) that result in end-organ damage or require systemic application
of immunosuppressive drugs
- Central nervous system (CNS) disease or symptoms of CNS involvement
- Pregnant or nursing (lactating) women
- Presence of Grade 2 or above non-hematologic toxicity , alopecia and grade 2
neuropathy excluded
- Any Iinappropriate conditions in the opinion of the PI .
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Nanchang University;
Address:
City:
Nanchang
Zip:
360000
Country:
China
Status:
Recruiting
Contact:
Last name:
Fei Li, MD
Phone:
13970038386
Email:
lifeigcp@2022@163.com
Investigator:
Last name:
Fei Li, MD
Email:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Rong Tao, MD
Phone:
8621-64175590
Email:
rtao@shca.org.cn
Contact backup:
Last name:
Wenhao Zhang, MD
Phone:
8621-64175590
Email:
zwhl98@foxmail.com
Investigator:
Last name:
Rong Tao, MD
Email:
Principal Investigator
Start date:
May 31, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
Rong Tao
Agency class:
Other
Collaborator:
Agency:
Novatim Immune Therapeutics (Zhejiang) Co., Ltd.
Agency class:
Industry
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06445803
