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A clinical study to evaluate the safety and effectiveness of IM19CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive non-Hodgkin's lymphoma

A clinical study to evaluate the safety and effectiveness of IM19CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive non-Hodgkin's lymphoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045919
Enrollment
Unknown
Registered
2021-04-28
Start date
2021-04-30
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Relapsed or refractory CD19-positive non-Hodgkin's lymphoma

Interventions

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with CD19-positive aggressive non-Hodgkin's lymphoma (NHL) who have relapsed or are refractory after at least two-line standard treatment, including diffuse large B lymphoma, grade 3 follicular lymphoma, and diffuse large B transformation Follicular lymphoma; CD20-positive patients should have received corresponding targeted therapy; 2. The patient must have evaluable disease evidence; 3. Aged >=18 years; 4. The expected survival period is more than 3 months; 5. ECOG score 0-2 points (refer to Annex 2); 6. Women of childbearing age who had a negative blood pregnancy test before the start of the test and agreed to take effective contraceptive measures during the test period until the last follow-up; 7. Blood routine: hemoglobin (Hb) >= 80g/L; absolute neutrophil count (ANC) > 1x 10^9/L; the total number of platelets (PLT) >= 50 x 10^9/L; 8. Volunteer to participate in this trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have graft-versus-host response and need to use immunosuppressive agents; or those who have autoimmune system diseases; 2. Those who used chemotherapy or radiotherapy within 3 days before the blood collection period; 3. Concomitant use of systemic steroids within 5 days before the blood collection period (except those who are using inhaled steroids recently or currently); 4. Those who used drugs that stimulate the production of bone marrow hematopoietic cells (Shengbai needle, etc.) within 5 days before the blood collection period; 5. Those who have used any gene therapy products before; 6. People with a history of epilepsy or other central nervous system diseases; 7. New York Heart Association (NYHA) graded above grade III (refer to Appendix 3); 8. Creatinine > 1.5 times the upper limit of normal or ALT/AST > 3 times the upper limit of normal or bilirubin > 2 times the upper limit of normal; 9. Active hepatitis B or C virus, HIV or other uncured active infection; 10. Pregnant or lactating women; 11. Those who suffer from other uncontrolled diseases that the researcher thinks are not suitable for joining; 12. Any situation that the researcher believes may increase the risk of the subject or interfere with the test results.

Design outcomes

Primary

MeasureTime frame
Curative effect index;Safety index;

Countries

China

Contacts

Public ContactHu Kai

Beijing Boren Hospital

huk@borenhospital.com+86 15010390336

Outcome results

None listed

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