Relapsed/Refractory Central Nervous System LymphomaPhase 1NCT07555561
Autologous CD19-CD20-NKG2D-nsBicephali CAR-T for Relapsed/Refractory Central Nervous System Lymphoma
A Phase 1 study testing Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection in people with Relapsed/Refractory Central Nervous System Lymphoma and Relapsed/Refractory Primary Central Nervous System Lymphoma, run by Beijing Boren Hospital at 1 site in China.
Trial summary
Central nervous system lymphoma (CNSL) includes primary CNS lymphoma (PCNSL) and secondary CNS lymphoma (SCNSL), with diffuse large B-cell lymphoma as the predominant pathological type. Disease progression is often rapid and the relapse rate is high. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Central Nervous System Lymphoma, Relapsed/Refractory Primary Central Nervous System Lymphoma, Relapsed/Refractory Secondary Central Nervous System Lymphoma
- What is being tested?
- Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, male or female.
- Good performance status: ECOG 0-2 or Karnofsky Performance Status (KPS) ≥70.
- Diagnosis of relapsed/refractory primary CNS lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL).
- PCNSL: prior treatment with at least 2 lines and unsuitable for autologous hematopoietic stem cell transplantation; or prior treatment with at least 3 lines; or disease progression/relapse within 12 months after autologous transplantation. Participants must previously have received at least 1 line of HD-MTX-based CNS-directed therapy (intravenous dose ≥2500 mg/m²) and have documented progression, relapse, or intolerance.
- SCNSL: relapse or refractory disease after at least 1 line of CNSL-directed therapy; if systemic lymphoma is also present, the systemic component must have relapsed after treatment including an anti-CD20 monoclonal antibody and an anthracycline.
- Presence of measurable CNS disease (at least one enhancing lesion ≥1 cm on contrast-enhanced brain MRI, or positive CSF by flow cytometry and/or cytology).
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- Positive expression of CD19 and/or CD20 in tumor biopsy tissue or malignant CSF cells. Participants with prior failure of single-target CD19- or CD20-directed therapy are allowed, provided the washout period since the last treatment is at least 6 months.
- Estimated life expectancy ≥12 weeks.
- Adequate organ function:
- Bone marrow and immune function: peripheral blood absolute CD3 count ≥50/mm³ and absolute lymphocyte count ≥0.2×10^9/L; ANC ≥1000/μL; platelets ≥50,000/μL, without recent red blood cell or platelet transfusion.
- Hepatic and renal function: creatinine clearance (Cockcroft-Gault) ≥45 mL/min; if relaxed to 30-45 mL/min, fludarabine dose must be reduced strictly; AST and ALT ≤3×ULN; total bilirubin and alkaline phosphatase ≤1.5×ULN.
- Cardiopulmonary function: LVEF ≥50% (NYHA class I-II); oxygen saturation on room air >92%.
- Prior-treatment washout: anti-B-cell chemotherapy/immunotherapy stopped for at least 3 weeks; intrathecal CNS therapy stopped for at least 1 week; systemic corticosteroids (except physiologic replacement) stopped for at least 1 week; short-acting cytotoxic drugs stopped for at least 3 days.
- Negative pregnancy test for women of childbearing potential; participants with partners of childbearing potential must agree to use effective contraception during treatment and for 24 months after infusion.
- Voluntary participation and signed informed consent.
Who cannot join
- High-risk CNS status: imaging showing high-risk brain herniation or uncontrollable intracranial pressure elevation risk (large subcortical mass effect with significant cerebral edema), or severe status epilepticus or poorly controlled seizures within 14 days.
- Prior severe CAR-T toxicity: prior CD19/CD20-targeted therapy (including CAR-T or bispecific antibodies) with grade IV CRS or ICANS, or grade III CRS/ICANS without full recovery after treatment.
- Uncontrolled serious active infection requiring systemic intravenous therapy.
- Positive virology: active hepatitis B (HBsAg positive and peripheral blood HBV DNA ≥10^3 copies/mL); hepatitis C (HCV RNA positive); positive syphilis screening with titer ≥1:8; HIV antibody positive.
- Toxicity from prior antitumor therapy not recovered to CTCAE v5.0 grade ≤2, except alopecia or fatigue.
- Severe cardiovascular or respiratory disease, including myocardial infarction, unstable angina, or severe arrhythmia within the past 6 months; moderate-to-severe pulmonary arterial hypertension; or need for ventilatory support or oxygen reservoir mask assistance.
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- Prior history of, or concurrent, other active malignancy, except cured carcinoma in situ or basal cell skin cancer.
- History of major solid organ transplantation.
- Active tuberculosis at screening, or latent tuberculosis without systematic prophylaxis.
- Live vaccine received within 6 weeks before lymphodepleting conditioning.
- Pregnancy or breastfeeding; severe allergy to any lymphodepleting drug or any component of the CAR-T product.
- Severe psychiatric disease, major depression, suicidal tendency, or any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19-CD20-NKG2D-nsBicephali CAR-T for Relapsed/Refractory Central Nervous System Lymphoma
Central nervous system lymphoma (CNSL) includes primary CNS lymphoma (PCNSL) and secondary CNS lymphoma (SCNSL), with diffuse large B-cell lymphoma as the predominant pathological type. Disease progression is often rapid and the relapse rate is high. Current standard treatment is centered on CNS-directed regimens based on high-dose methotrexate (HD-MTX), but salvage options for relapsed or refractory disease remain limited. In addition, the blood-brain barrier restricts effective exposure of many drugs within the central nervous system, making deep remission and durable disease control difficult to achieve. This study evaluates autologous CD19-CD20-NKG2D-nsBicephali CAR-T in patients with relapsed or refractory PCNSL or SCNSL. By engineering the patient's T cells into effector cells capable of recognizing both CD19 and CD20, this approach is intended to address tumor antigen heterogeneity and reduce immune escape associated with downregulation or loss of a single target. CAR-T cells may also migrate into cerebrospinal fluid and brain parenchyma, expand within the CNS compartment, and directly eliminate CD19/CD20-positive lymphoma cells. The study is designed to systematically evaluate the safety and preliminary efficacy of this investigational CAR-T therapy in relapsed or refractory CNSL.
Read the detailed description
This is a single-center, open-label exploratory clinical study to evaluate the safety, tolerability, and efficacy of autologous CD19-CD20-NKG2D-nsBicephali CAR-T in relapsed/refractory central nervous system lymphoma. The study has two stages. The first stage is a dose-escalation stage with two planned dose groups: a low-dose group of 1×10^6 CAR-positive T cells/kg and a high-dose group of 2×10^6 CAR-positive T cells/kg. A 3+3 design will be used for dose escalation. After enrollment and completion of the DLT observation period in each dose group, available safety and pharmacokinetic data will be reviewed to determine subsequent enrollment and treatment decisions, including whether additional dose groups should be added. The second stage is a dose-expansion stage. Once a given dose group is confirmed to be safe, that dose group and any lower confirmed dose groups may be expanded concurrently. Participants will be followed for safety and efficacy for 24 months after cell infusion. After completion of the main study, participants will be re-consented for long-term safety follow-up until 15 years after cell infusion.
- Conditions
- Relapsed/Refractory Central Nervous System Lymphoma, Relapsed/Refractory Primary Central Nervous System Lymphoma, Relapsed/Refractory Secondary Central Nervous System Lymphoma
- Being tested
- Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection
- Keywords
- CNSL, PCNSL, SCNSL, CAR-T, CD19, CD20
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell InjectionBiological
Autologous CD19-CD20-NKG2D-nsBicephali CAR-T is an autologous cell product derived from the participant's own cells. Peripheral blood mononuclear cells are collected by leukapheresis, T cells are isolated, and viral transduction is used ex vivo to generate autologous CAR-T cells for reinfusion. The product name stated in the protocol is Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection. Package specification is approximately 10-40 mL per dose. Transport condition is 2-8°C. Storage condition is sealed, protected from light, and maintained in liquid nitrogen conditions.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Low-dose autologous CD19-CD20-NKG2D-nsBicephali CAR-T | Experimental | a low-dose group of 1×10^6 CAR-positive T cells/kg Receives: Biological: Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection |
| Experimental - High-dose autologous CD19-CD20-NKG2D-nsBicephali CAR-T | Experimental | a high-dose group of 2×10^6 CAR-positive T cells/kg Receives: Biological: Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with dose-limiting toxicity (DLT) within 28 days after infusion; determination of MTD or RP2D.
Measured: Within 28 days after infusion.
Grade and frequency of adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and adverse events of special interest (AESIs, including CRS and ICANS).
Measured: From signing of informed consent through 24 months after infusion or the end-of-study visit, whichever occurs first.
Secondary outcomes (15)
Proportion of participants achieving objective response
Measured: at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24.
Proportion of participants achieving complete response (CR)
Measured: Month 3 (3 months ±14 days)
Response categories (CR/CRu/PR/SD/PD)
Measured: Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24
Best overall response (BOR)
Measured: From Day 0 (CAR-T infusion) until disease progression, initiation of new anti-tumor therapy, death, or Month 24 after infusion, whichever occurs first; response is assessed at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24.
Time to response (TTR)
Measured: From Day 0 to the first documented PR or CR/CRu, assessed through Month 24 after infusion; tumor assessments are performed at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24.
Duration of response (DOR)
Measured: From the date of first documented CR/CRu/PR until first documented PD or death, whichever occurs first, assessed through Month 24 after infusion.
Progression-free survival (PFS)
Measured: From Day 0 until first documented disease progression or death, whichever occurs first, assessed through Month 24 after infusion.
Overall survival (OS)
Measured: From Day 0 until death from any cause, assessed through Month 24 after infusion.
CNS response components
Measured: Assessed at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24 after infusion.
In baseline CSF-positive participants only: CSF conversion to negative, CSF MRD conversion to negative if MRD is performed, and duration of CSF MRD negativity
Measured: Assessed at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24 after infusion; duration of CSF MRD negativity is assessed through Month 24.
Cmax
Measured: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
Tmax
Measured: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
AUC0h-28d
Measured: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
AUC0-last
Measured: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
PD parameters, including changes in peripheral blood CD19-CD20-NKG2D-positive cells and serum cytokines such as TNF-alpha and IFN-gamma before and after infusion
Measured: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Why it stopped: Due to the promulgation of State Council Order No. 818, this category of clinical trials is prohibited from conduct.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Central Nervous System LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Boren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555561
- Sponsor's protocol ID
- BJBR-2026-LBL-001
- Status last verified
- Jun 2026
- First submitted
- 14 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Evaluate the Safety and Efficacy of Autologous CD19-CD20-NKG2D-nsBicephali CAR-T for Relapsed/Refractory Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT07555561
- Acronym / sponsor ID
- BJBR-2026-LBL-001
- Conditions
- Relapsed/Refractory Central Nervous System Lymphoma, Relapsed/Refractory Primary Central Nervous System Lymphoma, Relapsed/Refractory Secondary Central Nervous System Lymphoma
- Keywords
- CNSL, PCNSL, SCNSL, CAR-T, CD19, CD20
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the promulgation of State Council Order No. 818, this category of clinical trials is prohibited from conduct.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Boren HospitalUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Central nervous system lymphoma (CNSL) includes primary CNS lymphoma (PCNSL) and secondary CNS lymphoma (SCNSL), with diffuse large B-cell lymphoma as the predominant pathological type. Disease progression is often rapid and the relapse rate is high. Current standard treatment is centered on CNS-directed regimens based on high-dose methotrexate (HD-MTX), but salvage options for relapsed or refractory disease remain limited. In addition, the blood-brain barrier restricts effective exposure of many drugs within the central nervous system, making deep remission and durable disease control difficult to achieve. This study evaluates autologous CD19-CD20-NKG2D-nsBicephali CAR-T in patients with relapsed or refractory PCNSL or SCNSL. By engineering the patient's T cells into effector cells capable of recognizing both CD19 and CD20, this approach is intended to address tumor antigen heterogeneity and reduce immune escape associated with downregulation or loss of a single target. CAR-T cells may also migrate into cerebrospinal fluid and brain parenchyma, expand within the CNS compartment, and directly eliminate CD19/CD20-positive lymphoma cells. The study is designed to systematically evaluate the safety and preliminary efficacy of this investigational CAR-T therapy in relapsed or refractory CNSL.
Detailed description
This is a single-center, open-label exploratory clinical study to evaluate the safety, tolerability, and efficacy of autologous CD19-CD20-NKG2D-nsBicephali CAR-T in relapsed/refractory central nervous system lymphoma. The study has two stages. The first stage is a dose-escalation stage with two planned dose groups: a low-dose group of 1×10^6 CAR-positive T cells/kg and a high-dose group of 2×10^6 CAR-positive T cells/kg. A 3+3 design will be used for dose escalation. After enrollment and completion of the DLT observation period in each dose group, available safety and pharmacokinetic data will be reviewed to determine subsequent enrollment and treatment decisions, including whether additional dose groups should be added. The second stage is a dose-expansion stage. Once a given dose group is confirmed to be safe, that dose group and any lower confirmed dose groups may be expanded concurrently. Participants will be followed for safety and efficacy for 24 months after cell infusion. After completion of the main study, participants will be re-consented for long-term safety follow-up until 15 years after cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - Low-dose autologous CD19-CD20-NKG2D-nsBicephali CAR-T | Experimental | Biological: Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injectiona low-dose group of 1×10^6 CAR-positive T cells/kg |
| Experimental - High-dose autologous CD19-CD20-NKG2D-nsBicephali CAR-T | Experimental | Biological: Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injectiona high-dose group of 2×10^6 CAR-positive T cells/kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-75 years, male or female.
- Good performance status: ECOG 0-2 or Karnofsky Performance Status (KPS) ≥70.
- Diagnosis of relapsed/refractory primary CNS lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL).
- Presence of measurable CNS disease (at least one enhancing lesion ≥1 cm on contrast-enhanced brain MRI, or positive CSF by flow cytometry and/or cytology).
- Positive expression of CD19 and/or CD20 in tumor biopsy tissue or malignant CSF cells. Participants with prior failure of single-target CD19- or CD20-directed therapy are allowed, provided the washout period since the last treatment is at least 6 months.
Key exclusion criteria (12 listed)
- High-risk CNS status: imaging showing high-risk brain herniation or uncontrollable intracranial pressure elevation risk (large subcortical mass effect with significant cerebral edema), or severe status epilepticus or poorly controlled seizures within 14 days.
- Prior severe CAR-T toxicity: prior CD19/CD20-targeted therapy (including CAR-T or bispecific antibodies) with grade IV CRS or ICANS, or grade III CRS/ICANS without full recovery after treatment.
- Uncontrolled serious active infection requiring systemic intravenous therapy.
- Positive virology: active hepatitis B (HBsAg positive and peripheral blood HBV DNA ≥10^3 copies/mL); hepatitis C (HCV RNA positive); positive syphilis screening with titer ≥1:8; HIV antibody positive.
- Toxicity from prior antitumor therapy not recovered to CTCAE v5.0 grade ≤2, except alopecia or fatigue.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell InjectionAutologous CD19-CD20-NKG2D-nsBicephali CAR-T is an autologous cell product derived from the participant's own cells. Peripheral blood mononuclear cells are collected by leukapheresis, T cells are isolated, and viral transduction is used ex vivo to generate autologous CAR-T cells for reinfusion. The product name stated in the protocol is Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection. Package specification is approximately 10-40 mL per dose. Transport condition is 2-8°C. Storage condition is sealed, protected from light, and maintained in liquid nitrogen conditions. | Biological | Experimental - High-dose autologous CD19-CD20-NKG2D-nsBicephali CAR-T, Experimental - Low-dose autologous CD19-CD20-NKG2D-nsBicephali CAR-T |
Primary outcome
Proportion of participants with dose-limiting toxicity (DLT) within 28 days after infusion; determination of MTD or RP2D.
Time frame: Within 28 days after infusion.
Grade and frequency of adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and adverse events of special interest (AESIs, including CRS and ICANS).
Time frame: From signing of informed consent through 24 months after infusion or the end-of-study visit, whichever occurs first.
15 secondary outcomes
Proportion of participants achieving objective response
Time frame: at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24.
Proportion of participants achieving complete response (CR)
Time frame: Month 3 (3 months ±14 days)
Response categories (CR/CRu/PR/SD/PD)
Time frame: Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24
Best overall response (BOR)
Time frame: From Day 0 (CAR-T infusion) until disease progression, initiation of new anti-tumor therapy, death, or Month 24 after infusion, whichever occurs first; response is assessed at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24.
Time to response (TTR)
Time frame: From Day 0 to the first documented PR or CR/CRu, assessed through Month 24 after infusion; tumor assessments are performed at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24.
Duration of response (DOR)
Time frame: From the date of first documented CR/CRu/PR until first documented PD or death, whichever occurs first, assessed through Month 24 after infusion.
Progression-free survival (PFS)
Time frame: From Day 0 until first documented disease progression or death, whichever occurs first, assessed through Month 24 after infusion.
Overall survival (OS)
Time frame: From Day 0 until death from any cause, assessed through Month 24 after infusion.
CNS response components
Time frame: Assessed at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24 after infusion.
In baseline CSF-positive participants only: CSF conversion to negative, CSF MRD conversion to negative if MRD is performed, and duration of CSF MRD negativity
Time frame: Assessed at Day 28 and Months 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24 after infusion; duration of CSF MRD negativity is assessed through Month 24.
Cmax
Time frame: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
Tmax
Time frame: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
AUC0h-28d
Time frame: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
AUC0-last
Time frame: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
PD parameters, including changes in peripheral blood CD19-CD20-NKG2D-positive cells and serum cytokines such as TNF-alpha and IFN-gamma before and after infusion
Time frame: Assessed from Day 0 through Month 24 after infusion on Days 0, 1, 3, 5, 7, 9, 11, 14, 21, and 28; Months 2, 3, 6, 9, 12, 15, 18, and 24; and through study completion or early withdrawal, up to 24 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous CD19-CD20-NKG2D-nsBicephali CAR-T Cell Injection in people with Relapsed/Refractory Central Nervous System Lymphoma and Relapsed/Refractory Primary Central Nervous System Lymphoma, run by Beijing Boren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with dose-limiting toxicity (DLT) within 28 days after infusion; determination of MTD or RP2D. (time frame: Within 28 days after infusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.