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Clinical study of autologous and fully human CS-1-CART in the treatment of relapsed and refractory multiple myeloma

Clinical study of autologous and fully human CS-1-CART in the treatment of relapsed and refractory multiple myeloma

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043250
Enrollment
Unknown
Registered
2021-02-09
Start date
2021-01-26
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

Relapsed and refractory multiple myeloma

Interventions

Sponsors

Beijing Boren Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. RRMM patients with CART treatment targets (CS-1 or CD319/SLAMF7) still have residual lesions after two-line treatment and have negative BCMA expression or progress after BCMA-CART treatment; 2. The patient must have an assessable disease certificate, including minimal residual disease; 3. Aged 18-75 years, including boundary value, self-knowledge, able to sign informed consent; 4. The expected survival period is more than 3 months; 5. ECOG score 0-2 points; 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.

Exclusion criteria

Exclusion criteria: 1. Intracranial hypertension or unconsciousness; 2. Symptomatic heart failure or severe arrhythmia; 3. Respiratory failure; 4. With other types of malignant tumors; 5. Diffuse intravascular coagulation; 6. Serum creatinine and/or urea nitrogen >= 1.5 times the normal value; 7. Sepsis or other infections that are difficult to control; 8. Uncontrollable diabetes; 9. Severe mental disorder; 10. There are obvious intracranial lesions in head MRI examination; 11. Cerebrospinal fluid examination of myeloma cells>20/ul; 12. The proportion of blood tumor cells > 30%; 13. ECOG score >= 2 points; 14. Organ transplant recipients; 15. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Safety index;Effectiveness index;

Countries

China

Contacts

Public ContactKai Hu

Beijing Boren Hospital

huk@gobroadhealthcare.com+86 15010390336

Outcome results

None listed

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