Diffuse Large B Cell LymphomaEarly Phase 1NCT05673447
The Study of Anti-CD19 CAR NK Cells in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma
A Early Phase 1 study testing anti-CD19 CAR NK cells in people with Diffuse Large B Cell Lymphoma, run by Changhai Hospital at 1 site in China.
Trial summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells in patients with B-cell Non Hodgkin Lymphoma. 9-12 patients are planned to be enrolled in the dose-escalation trial (6×10^8 cells, 1×10^9 cells, 1.5×10^9 cells). The primary endpoints are DLT, MTD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- anti-CD19 CAR NK cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Dec 2024
- Phase
- Early 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
- Clinical diagnosis of CD19 positive diffuse large B cell lymphoma as defined by the 2017 World Health Organization (WHO) classification of tumors of haematopoietic and lymphoid tissue.
- Relapsed/Refractory diffuse large B cell lymphoma refers to: not complete response (CR) of 2 lines of standard treatment; PD after treatment or duration of SD less than 6 months after treatment; progress or relapse within 12 months after autologous stem cell transplant.
- Subjects with a measurable or evaluable lesion (more than one lesion≥15mm) according to IWG criteria.
- Age≥ 18 years old and ≤ 75 years old, male or female.
- Subjects with estimated survival > 12 weeks.
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- Serum albumin (ALB) ≥30g/L, Total Bilirubin (TBIL) ≤ 25.7μmol/L, serum creatinine (SCr) ≤ 132.6μmol/L, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN).
- Absolute neutrophil count (ANC) ≥ 1.0×109/L, platelet count ≥ 50×109/L.
- ECOG performance ≤ 1.
- Left ventricular ejection fraction (LVEF) ≥50% and no clinically significant pericardial effusion.
- ≥ 4 weeks after subjects received last dose treatment (Radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments).
Who cannot join
- Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions.
- Relapsed after allogenic haemopoietic stem cell transplantation (HSCT).
- Subjects with active infection receiving intravenous (IV) antibiotic treatment, or received intravenous (IV) antibiotic treatment within one week prior to anti-CD19 CAR NK Cell infusion.
- Subjects with acquired and congenital immunodeficiency diseases.
- Subjects with grade III or IV heart failure (NYHA classification).
- History of epilepsy or other central nervous system (CNS) diseases.
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- Subjects with extranodal lymphoma in Intracranial, lung, or gastrointestinal tract.
- History of other primary malignant tumors except:
- Cured non-melanoma skin cancer by surgical excision, for example basal cell carcinoma (BCC);
- Cured primary malignant tumors, such as cervical cancer, superficial bladder cancer, breast cancer.
- Systemic corticosteroids are used concomitantly within 2 weeks prior to treatment.
- Females who are pregnant, lactating, or planning a pregnancy within six months.
- Subjects who have received other clinical trial treatment within 3 months.
- Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai
Jianmin Yang, Doctor, 86-18317172636, yangjianmin@csco.org.cn
About this study
Official title: An Exploratory Clinical Study of Safety and Efficacy of Anti-CD19 CAR NK Cells in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells in patients with B-cell Non Hodgkin Lymphoma. 9-12 patients are planned to be enrolled in the dose-escalation trial (6×10^8 cells, 1×10^9 cells, 1.5×10^9 cells). The primary endpoints are DLT, MTD. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR).
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- anti-CD19 CAR NK cells
- Keywords
- B-Cell Lymphoma, CD19, CAR-NK, diffuse diffuse large B cell lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19 CAR NK cellsBiological
Patients will receive Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3. Doses of 6×10^8, 1×10^9, 1.5×10^9 Anti-CD19 CAR NK cells will infused in each group using the "3 + 3" dose-escalation strategy.
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19 CAR NK cells | Experimental | CD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy. Receives: Biological: anti-CD19 CAR NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLTs)
To characterize the safety, tolerability, and determine the Maximum tolerated dose (MTD) of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma.
Measured: within 4 weeks after infusion
Incidence of Treatment Emergent Adverse Events (TEAEs)
To characterize the safety of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma
Measured: up to 48 weeks after infusion
Secondary outcomes (2)
The overall response rate (ORR)
To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for Relapsed/Refractory diffuse large B cell lymphoma
Measured: 1, 3, 6 and 12 months after infusion
Disease control rate (DCR)
To characterize the efficacy of Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin Lymphoma.
Measured: 1, 3, 6, 12 and 12 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Mar 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Enricnk Biotech Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673447
- Sponsor's protocol ID
- CHEC2022-251
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Safety and Efficacy of Anti-CD19 CAR NK Cells in the Treatment of Relapsed/Refractory Diffuse Large B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05673447
- Acronym / sponsor ID
- CHEC2022-251
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- B-Cell Lymphoma, CD19, CAR-NK, diffuse diffuse large B cell lymphoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Nanjing Enricnk Biotech Co., Ltd
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 6 Jan 2023 (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.
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19 CAR NK cells in patients with B-cell Non Hodgkin Lymphoma. 9-12 patients are planned to be enrolled in the dose-escalation trial (6×10^8 cells, 1×10^9 cells, 1.5×10^9 cells). The primary endpoints are DLT, MTD. The secondary endpoints are the overall response rates (ORR) and disease control rate (DCR).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19 CAR NK cells | Experimental | Biological: anti-CD19 CAR NK cellsCD19-CAR-NK is an allogenic CD19-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF).
- Clinical diagnosis of CD19 positive diffuse large B cell lymphoma as defined by the 2017 World Health Organization (WHO) classification of tumors of haematopoietic and lymphoid tissue.
- Relapsed/Refractory diffuse large B cell lymphoma refers to: not complete response (CR) of 2 lines of standard treatment; PD after treatment or duration of SD less than 6 months after treatment; progress or relapse within 12 months after autologous stem cell transplant.
- Subjects with a measurable or evaluable lesion (more than one lesion≥15mm) according to IWG criteria.
- Age≥ 18 years old and ≤ 75 years old, male or female.
Key exclusion criteria (14 listed)
- Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions.
- Relapsed after allogenic haemopoietic stem cell transplantation (HSCT).
- Subjects with active infection receiving intravenous (IV) antibiotic treatment, or received intravenous (IV) antibiotic treatment within one week prior to anti-CD19 CAR NK Cell infusion.
- Subjects with acquired and congenital immunodeficiency diseases.
- Subjects with grade III or IV heart failure (NYHA classification).
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 |
|---|---|---|
| anti-CD19 CAR NK cellsPatients will receive Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3. Doses of 6×10^8, 1×10^9, 1.5×10^9 Anti-CD19 CAR NK cells will infused in each group using the "3 + 3" dose-escalation strategy. | Biological | anti-CD19 CAR NK cells |
Primary outcome
Incidence of dose limiting toxicity (DLTs)
Time frame: within 4 weeks after infusion
To characterize the safety, tolerability, and determine the Maximum tolerated dose (MTD) of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: up to 48 weeks after infusion
To characterize the safety of Anti-CD19 CAR NK Cells for Relapsed/Refractory diffuse large B cell lymphoma
2 secondary outcomes
The overall response rate (ORR)
Time frame: 1, 3, 6 and 12 months after infusion
Disease control rate (DCR)
Time frame: 1, 3, 6, 12 and 12 months after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing anti-CD19 CAR NK cells in people with Diffuse Large B Cell Lymphoma, run by Changhai 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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 28 Aug 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianmin Yang, Ph. D. (13918735105, chyangjianmin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLTs) (time frame: within 4 weeks 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 28 Aug 2023.