Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05247957
Other study ID # CARNK-001
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 13, 2021
Est. completion date December 20, 2022

Study information

Verified date January 2023
Source Hangzhou Cheetah Cell Therapeutics Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial will explore the maximum tolerated dose of cord blood NKG2D CAR-NK in the treatment of recurrent refractory acute myeloid leukemia in a dose-escalation manner, and observe its clinical safety and efficacy.


Description:

This is a single arm, open-label, Phase 1 study initiated with 3 cohorts: Cohort 1: 2×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 2: 6×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7 Cohort 3: 18×10∧6/kg CAR-NK cells, 2 infusions on Day 0 and Day 7


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date December 20, 2022
Est. primary completion date December 12, 2022
Accepts healthy volunteers No
Gender All
Age group 10 Years to 75 Years
Eligibility Inclusion Criteria: 1. Age: = 10 years old and = 75 years old, male or female; 2. Meet the diagnostic criteria for recurrent AML: detection of leukemia cells after complete remission (CR) or >0.1% of leukemia cells in bone marrow, including recurrence after allogeneic hematopoietic stem cell transplantation, or extramedullary infiltration of leukemia cells; 3. Initial cases with failure of 2 lines of standard treatment; patients who relapsed within 12 months after consolidation intensification after CR; recurrence in 12 months and no respond to conventional chemotherapy; 2 or more recurrences; persistent extramedullarial leukemia; 4. Patients currently have no effective treatment options, such as chemotherapy or allogeneic hematopoietic stem cell transplantation, or patients voluntarily choose to infuse NKG2D CAR-NK cells as the first treatment option; 5. Physical status assessment (ECOG-PS) of the Eastern Oncology Collaborative Group is 0-2 points; 6. Estimated survival > 3 months 7. Flow cytometry check for NKG2D ligand expression on the surface of cancer cells for a reference of selecting patients 8. The main organs of the patient are well functioned: (1) cardiac function: no heart disease or coronary heart disease, the patient's cardiac function grade 1-2; (2) liver function: TBIL?3ULN, AST?2.5ULN, ALT?2.5ULN; (3) Renal function: Cr?1.25ULN; 9. The patient's peripheral superficial vein can meet the needs of intravenous injection; 10. No other serious diseases that conflict with this protocol (e.g., autoimmune diseases, immunodeficiency, organ transplantation); 11. No history of other malignant tumors; 12. Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test; 13. Subjects have negative HIV, HBV, HCV, syphilis serology test results 14. Written informed consent form must be signed before enrollment. Exclusion Criteria: 1. Acute promyelocytic leukemia (type M3); 2. Patients with cardiac insufficiency, patients with hepatic and renal insufficiency; 3. Those who need treatment with other malignant tumors; 4. Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg) or clinically significant cardiovascular and cerebrovascular diseases such as cerebrovascular accident (within 6 months before signing the informed consent form), myocardial infarction (within 6 months before signing the informed consent), unstable angina, congestive heart failure, or severe arrhythmias that cannot be controlled with drugs or have a potential impact on research treatment; 5. Also suffering from other hematologic diseases (such as hemophilia, myelofibrosis, etc., which researchers consider unsuitable for inductees); 6. Diffuse vascular internal coagulation; 7. Concomitant serious infection or other serious underlying medical condition; 8. Have immunodeficiency and autoimmune diseases; 9. Have severe allergic diseases; 10. Clinical symptoms of brain dysfunction or severe mental illness that can not understand or follow the research protocol; 11. Have participated in clinical trials of other drugs within 4 weeks or within 21 days of surgery; 12. Have received cell therapy in the previous 1 month; 13. Have received hormonal drug therapy in the previous 14 days; 14. Known HIV-positive patients or hepatitis B and C patients and syphilis patients; 15. Have received organ transplants (excluding stem cell transplant patients); 16. Drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study; 17. Pregnant or lactating women; 18. Those who cannot be followed up as scheduled; 19. Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.

Study Design


Intervention

Biological:
CAR-NK cells
NKG2DL-specific CAR-NK cells, 2 infusions on Day 0 and Day 7

Locations

Country Name City State
China Hebei Yanda Lu Daopei Hospital Sanhe Hebei

Sponsors (1)

Lead Sponsor Collaborator
Hangzhou Cheetah Cell Therapeutics Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-Limiting Toxicity To evaluate the clinical safety and short-term efficacy of NKG2D ligand-specific umbilical cord blood CAR-NK cells in the treatment of patients with relapsed refractory acute myeloid leukemia by intravenous infusion 28 days
Primary Maximal Tolerable Dose tolerability evaluationtransplantation after intravenous infusion of NKG2D ligand-specific umbilical cord blood CAR-NK cells for patients with relapsed refractory acute myeloid leukemia 28 days
Secondary leukemia-free survival#LFS# leukemia-free survival 52weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04994210 - Sintilimab in Combination With Chidamide in Newly Diagnosed ENKTCL Phase 2
Completed NCT04621123 - Plasma for Early Treatment in Non-hospitalised Mild or Moderate COVID-19 Patients Phase 2
Recruiting NCT05140616 - Study of Chidamide for Steroid-resistant/Steroid-dependent Severe cGVHD Phase 1/Phase 2
Recruiting NCT05349552 - Safety and Efficacy of SBRT in the Treatment of Thoracic Malignant Tumors at Different Sites
Completed NCT03820596 - Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL Phase 1/Phase 2
Completed NCT02018250 - Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS) Phase 1
Recruiting NCT04446806 - Prevention and Treatment of Differentiation Syndrome in Patients With Acute Promyelocytic Leukemia Phase 4
Recruiting NCT05556889 - Safety and Analgesic Efficacy of a Modified Auriculotemporal Nerve Block N/A
Not yet recruiting NCT06244537 - Study on the Safety and Efficacy of MR-Linac Technique in Patients With Unresectable Locally Advanced Colon Cancer N/A
Recruiting NCT03455972 - Study of T Cells Targeting CD19/BCMA (CART-19/BCMA) for High Risk Multiple Myeloma Followed With Auto-HSCT Phase 1/Phase 2
Completed NCT04785170 - Clinical Study to Evaluate Safety and Efficacy of Amino Acid in Healthy Individuals N/A
Recruiting NCT04677452 - Dose Exploration Study OF JWCAR129, BCMA-Targeted CART for RRMM Phase 1
Completed NCT01305044 - The HEALS Project - Health Education and Active Living for Surviving Seniors Phase 2
Active, not recruiting NCT04646590 - A Phase III Clinical Trial to Determine the Safety and Efficacy of ZF2001 for Prevention of COVID-19 Phase 3
Recruiting NCT05021276 - Basiliximab Combined With Ruxolitinib as Second-line Treatment of Grade 3-4 Steroid-resistant aGVHD Phase 4
Not yet recruiting NCT05008666 - Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs for ENKTL-HLH Phase 2
Recruiting NCT06066840 - Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement Phase 4
Active, not recruiting NCT04852068 - A Clinical Trial of Freeze-dried Human Rabies Vaccine (Vero Cells) Phase 3