Clinical study for anti-BCMA CAR-T in the treatment of refractory or recurrent plasmablastic lymphoma

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900025892

Enrollment

Unknown

Registered

2019-09-12

Start date

2019-09-01

Completion date

Unknown

Last updated

2019-09-16

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

Conditions

plasmablastic lymphoma

Interventions

Case series:CAR-T

Eligibility

Sex/Gender

All

Age

10 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients aged 5-70 years; 2. The ECOG score of the patients was for 12 weeks. 3. Diagnosis of refractory or recurrent plasmablastic lymphoma, no effective treatment, not suitable for hematopoietic stem cell transplantation or abandon transplantation due to conditions or recurrence after transplantation; 4. With measurable or evaluable lesions; 5. The main tissues and organs of the patients have good functions: (1) Liver function: ALT/AST =95%; (4) Cardiac function: left ventricular ejection fraction (LVEF) >=40%; 6. Voluntary car-t treatment for patients with plasmablastic lymphoma; 7. Blood can be extracted intravenously and there are no other contraindications for leucocyte removal; 8. Patients or their legal guardians voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients in pregnancy or breast-feeding period; Planning pregnancy within 6 months; 2. HIV or active TB infected or active hepatitis B or hepatitis C infection; 3. Feasibility assessment during screening demonstrates <10% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 4. Patients with abnormal vital signs or could not cooperate with inspectors; 5. History of mental disorders; 6. Highly allergic constitution or severe allergies, especially allergic to IL-2; 7. Systemic infection or serious infections should be local anti-infection treatment; 8. With heart, lung, brain, liver, kidney and other important organ dysfunction; 9. Other situations we think improper for the research.

Design outcomes

Primary

Measure	Time frame
Complete remission rate;Progression Free Survival;Overall Survival;Safety;	—

Countries

China

Contacts

Public ContactJiang Cao

The Affiliated Hospital of Xuzhou Medical University

zimu05067@163.com+86 13852432263

Outcome results

None listed

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