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A clinical trial on the efficacy and safety of autologous DC-CTL cell infusion in the treatment of malignant tumors

A clinical trial on the efficacy and safety of autologous DC-CTL cell infusion in the treatment of malignant tumors

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046306
Enrollment
Unknown
Registered
2021-05-12
Start date
2020-03-20
Completion date
Unknown
Last updated
2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Various Tumours

Interventions

single arm:autologous DC-CTL cell

Sponsors

University of Chinese academy of sciences Shenzhen hospital(guang ming)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 to 70 years, No gender limitation; 2.Patients diagnosed with cancer by histopathology or cytology; 3.(ECOG) Performance Status 0-2; 4.The survival of patients should longer than 3 months, and accept follow-up visit. 5.Patients with solid tumor still have residual lesions after treatment and are not suitable for or unwilling to accept other anti-tumor therapies such as radiotherapy and chemotherapy 6.Blood tumors are in remission after treatment and are not suitable for or are unwilling to receive radiotherapy or chemotherapy or other anti-tumor therapies; 7.Patients did not receive any anticancer therapy such as chemotherapy, radiotherapy and immunotherapy (such as immunosuppressive drugs) within 2-4 weeks before enrollment, and their previous treatment-related toxicity had recovered to <1 level at enrollment (except for low toxicity such as alopecia and peripheral neuritis). 8.The patient's venous passage is unobtrusive, which can meet the needs of intravenous infusion. 9.All the patients volunteer should rule out pregnancy until the follow-up completed. 10. The patients volunteer to join in the trial and sign the informed consents.

Exclusion criteria

Exclusion criteria: 1.Patients received high dose of corticosteroids (except for patients who received inhaled corticosteroids) within 1 week before enrollment; 2.Patient suffering from serious autoimmune diseases, immunodeficiency diseases or severe allergies; 3.Patients had uncontrolled infections within 4 weeks prior to enrollment; 4.Hepatitis C virus (anti-HCV positive, HCV RNA positive), HIV positive, syphilis positive; 5.Patients had participated in other clinical studies within 6 weeks prior to enrollment; 6.Patients suffering from mental illness; 7.Patients with substance abuse/addiction and medical, psychological or social conditions that may interfere with the study or have an impact on the evaluation of the study results; 8.The patient was alcohol dependent; 9.Women who are pregnant (positive for urine/blood pregnancy studies) or lactating; Men or women who have planned to give birth within the past 1 year; Patients were not guaranteed effective contraception during the study period; 10.Patients with a definite diagnosis of T-cell leukemia or T-cell lymphoma; 11.According to the researchers' judgment, the patients had other unsuitable conditions for enrollment.

Design outcomes

Primary

MeasureTime frame
objective remission rate, ORR;disease control rate, DCR;progression-free survival, PFS;overall survival, OS;

Countries

China

Contacts

Public ContactShu Xu

University of Chinese Academy of Sciences Shenzhen Hospital (Guangming)

68612844@qq.com+86 18126081801

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026