Clinical trial · Interventional
A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
A Study Evaluating Safety and Efficacy of CBM.CD20 CAR-T(C-CAR066) in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
NCT04316624CI-TRIAL-00103061completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL who received CD19 CAR-T therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-CAR066 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-CAR066
- description
- Autologous C-CAR066 (CD20-directed CAR T-cell) administered by intravenous (IV) infusion
- interventionNames
- Drug: C-CAR066
Primary outcomes (1)
- measure
- The incidence of adverse events
- timeFrame
- Up to 12 weeks after C-CAR066 infusion
- description
- The incidence of treatment-emergent adverse events (TEAEs)
Secondary outcomes (5)
- measure
- Objective response rate (ORR)
- timeFrame
- Up to 24 months after C-CAR066 infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
1. The patient volunteered to participate in the study, and signed the Informed Consent
2. Age 18-75 years old, male or female
3. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm)
4. r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
5. At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
6. Adequate organ and bone marrow fuction
7. No contraindications of apheresis
8. Expected survival time \> 3 months
9. ECOG scores 0 - 1
Exclusion Criteria:
1. Have a history of allergy to cellular products
2. Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
3. A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
4. Patients with active CNS involvement
5. Patients with autoimmune disease, immunodeficiency, or other treatment requiring inhibitors
6. Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
7. Live vaccination within 4 weeks before peripheral blood apheresis
8. HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
9. Have a history of alcoholism, drug addiction and mental illness
10. Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
11. Patients with severe fludarabine or cyclophosphamide hypersensitivity
12. The patient has a history of other primary cancers, except for the following:
1. Non-melanoma such as skin basal cell carcinoma cured by resection
2. Cured carcinoma in situ such as cervical, bladder or breast cancer
13. The investigators believe that there are other circumstances that are not suitable for the trialReferences
Publications (1)
- DERIVEDLi P, Liu W, Zhou L, Ye S, Zhu D, Huang J, Li J, Zheng C, Zhu S, Yao X, Zhu K, Yao Y, Qiu L, Liang A, Zou D. C-CAR066, a novel fully human anti-CD20 CAR-T therapy for relapsed or refractory large B-cell lymphoma after failure of anti-CD19 CAR-T therapy: A phase I clinical study. Am J Hematol. 2024 Dec;99(12):2306-2312. doi: 10.1002/ajh.27488. Epub 2024 Oct 1. PMID 39351902