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A clinical study on the therapeutic safety, tolerability, efficacy and pharmacokinetic characteristics of chimeric antigen receptor T cells in patients with hematological malignancies

A clinical study on the therapeutic safety, tolerability, efficacy and pharmacokinetic characteristics of chimeric antigen receptor T cells in patients with hematological malignancies

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043305
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Hematological malignancies

Interventions

Sponsors

Shanghai Zhaxin Integrated Traditional Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with positive target markers confirmed by flow cytometry had primary drug resistance, relapse during chemotherapy, and relapse after drug withdrawal or hematopoietic stem cell transplantation; 2. Subjects aged 14-70 years old, including boundary value; Chinese nationality 3. Patients over 18 years old with self-knowledge ability voluntarily sign the informed consent, and children under 18 years old voluntarily sign the informed consent by their legal representative (Guardian); 4. Subjects with ECoG score of 0-3; 5. Women of childbearing age who had negative pregnancy test before the trial and agreed to take effective contraceptive measures during the trial until the last follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with severe acute organ dysfunction, such as liver dysfunction (alt, AST are more than 10 times higher than the normal range), renal dysfunction (BUN, SCR are more than 2 times higher than the normal baseline value), severe arrhythmia or heart failure, dyspnea or respiratory failure; 2. Patients with coagulation dysfunction and bleeding of important organs; 3. Patients with intracranial hypertension or cerebral disturbance of consciousness, or other central nervous system diseases; 4. Subjects with bloodstream infection or other uncontrollable infection; 5. Subjects with grade 2 aGVHD or moderate cGVHD; 6. Subjects with active hepatitis B or C virus infection, syphilis, HIV, cytomegalovirus and Epstein Barr virus infection; 7. Patients with other types of malignant tumors; 8. Pregnant or lactating women; 9. Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.

Design outcomes

Primary

MeasureTime frame
Safety evaluation index;Pharmacokinetic evaluation index;Curative effect evaluation index;

Countries

China

Contacts

Public ContactChun Wang

Shanghai Zhaxin integrated traditional Chinese and Western Medicine Hospital

wangc@gobroadhealthcare.com+86 13386259777

Outcome results

None listed

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