B-cell Non-Hodgkin's LymphomaPhase 1/2NCT05091541
A Phase 1/2 Study of CT120 in Patient With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
A Phase 1/2 study testing Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection in people with B-cell Non-Hodgkin's Lymphoma, run by Nanjing IASO Biotechnology Co., Ltd..
Trial summary
This study is a single-armed, open-label,multicenter Phase 1/2 study to evaluate the safety and efficacy of CT120 in subjects with relapsed/refractory B-cell non-Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B-cell Non-Hodgkin's Lymphoma
- What is being tested?
- Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2021to 20 Oct 2039
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age between 18 and 70 years old.
- Pathologically confirmed B-cell non-Hodgkin's lymphoma, including:
- Diffuse large B-cell lymphoma (DLBCL); (2) Histopathological Grade 3b follicular lymphoma (FL3b); (3) Follicular lymphoma with diffuse large B cell transformation; (4) Primary mediastinal large B-cell lymphoma (PMBCL). 3. Relapsed/refractory B-cell non-Hodgkin's lymphoma must meet one of the following criteria:
- At least 2 failed prior B-cell non-Hodgkin's lymphoma treatment regimens (including relapse, no response, and progression). Prior therapy must have included anti-CD20 monoclonal antibodies (except for CD20-negative subjects) and standard therapies which including anthracyclines;
- Recurrence after autologous hematopoietic stem cell transplantation;
- Primary resistance: After 2 cycles of initial anti-CD20 monoclonal immunochemotherapy, the best response was stable disease or disease progression.
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- 4. At least 1 measurable lesion as following:
- The long axis of the lymph node lesions should be ≥15mm (and the length of the short axis is measurable), or;
- The lengths of extra-lymph node lesions should be ≥10mm in both the long and short axis.
- 5. Expected survival time≥12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate organ function before enrollment, and meet all the following laboratory test results:
- Blood routine: neutrophils ≥1.0 ×109/L (granulocyte colony stimulating factor (G-CSF) is allowed within 7 days before the examination), lymphocytes ≥0.3 ×109 /L, platelets ≥50 ×109 /L (must have not received blood transfusion [including component transfusion] or treatments that include thrombopoietin [TPO] for the purpose of raising platelets within 7 days before the examination), hemoglobin ≥80g/L (must have not received blood transfusion [including component blood transfusion] within 7 days before the examination);
- Blood coagulation function: fibrinogen≥1.0g/L; activated partial thromboplastin time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;
- Liver function: ALT and AST≤2.5×ULN; serum total bilirubin≤1.5×ULN;
- Renal function: creatinine clearance rate CrCl ≥60 mL/min estimated by Cockcroft-Gault;
- Left ventricular ejection fraction (LVEF)≥50% estimated by echocardiography;
- Baseline oxygen saturation > 91% on room air. 8. Females and males with childbearing potential should take effective contraception from the day of signing the informed consent form to 365 days after the CT120 infusion. Effective contraception is defined as: abstinence or contraceptive methods with an annual failure rate of <1% indicated in section 9.8 of this protocol.
- 9. Subject is willing to participate in this trial and sign an informed consent form.
Who cannot join
- Subjects who have received or require the following treatments:
- Prior CAR-T cell therapy before enrollment; (2) Presence of acute or chronic graft-versus-host disease (GVHD) requires systemic treatment within 4 weeks before enrollment; (3) History of immunodeficiency or other diseases and autoimmune diseases (eg Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) received immunosuppressive therapy within 2 years before enrollment; (4) Autologous hematopoietic stem cell transplantation (autoSCT) within 12 weeks before enrollment and history of allogeneic stem cell transplantation (HSCT); (5) Live vaccines injection within 4 weeks before enrollment; (6) According to investigator's discretion, there is a need to use systemic corticosteroid therapy within 12 weeks after the administration of the study drug (except for hydrocortisone ≤12mg/m2/day or other hormones converting into the same dose range for physiological replacement therapy) or other immunosuppressive drug therapy (except local therapy).
- 2. B-cell non-Hodgkin's lymphoma patients with active central nervous system or intestinal parenchyma invasion.
- 3. Excessive tumor burden and any lesions with a long axis ≥10cm. 4. Other active malignant tumors in the past 5 years, except for curable tumor that has been completely cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.
- 5. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and an abnormal HBV DNA result detected by peripheral blood test (abnormal HBV DNA result is defined as: the quantitative detection of HBV DNA is over the detectable lower limit or beyond the normal reference of the testing center or HBV viral DNA positive); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA test positive; syphilis test positive.
- 6. Uncontrollable active infections (except for genitourinary system infections and upper respiratory tract infections < CTCAE Grade 2).
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- 7. Severe heart disease: including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ Grade III), severe arrhythmia.
- 8. Hypertension that cannot be controlled by medication. 9. Adverse events during prior therapies have not relieved to baseline or ≤1 (according to NCI-CTCAE v5.0, except for alopecia).
- 10. Major surgery within 2 weeks before enrollment, or surgeries that were planed while waiting for infusion or within 12 weeks after receiving investigational product (except planned local anesthesia surgery).
- 11. History of organ transplant. 12. Pregnant or lactating women. 13. Previous central nervous system diseases (such as cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, mental illness, etc.) or mental disorders.
- 14. Unstable systemic diseases judged by other researchers: including but not limited to severe liver, kidney, or metabolic diseases that require medication.
- 15. Other unsuitable situations for enrollment judged by investigators.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter Phase I/II Clinical Study on Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection (CT120) for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
This study is a single-armed, open-label,multicenter Phase 1/2 study to evaluate the safety and efficacy of CT120 in subjects with relapsed/refractory B-cell non-Hodgkin's lymphoma.
Read the detailed description
Leukapheresis procedure will be performed to manufacture CT120. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of CT120. Subjects will be followed in the study for a minimum of 2 years after CT120 infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT120 infusion.
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Being tested
- Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell InjectionDrug
Also called CT120
CT120 is an autologous CD19/22 targeted CAR-T cells injection. The dosage form is a cryopreserved injection solution. The T cells aphesis from subjects then been manufactured to express CAR to binding CD19 and CD22 on B-cell lymphoma.
| Study group | Role | What they receive |
|---|---|---|
| CT120 in relapsed/refractory B-cell non-Hodgkin's lymphoma patients | Experimental | Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection（CT120）will be infused at 1.0 x 10^6 CAR+ T cells/kg、3.0 x 10^6 CAR+ T cells/kg、6.0 x 10^6 CAR+ T cells/kg in relapsed/refractory B-cell non-Hodgkin's lymphoma patients Receives: Drug: Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Types and incidence of Dose-limiting toxicity (DLT)
Dose-limiting toxicity (DLT) will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
Measured: up to 28 days after CT120 infusion
Phase 1:Types and incidence of adverse events (AEs) ，serious adverse events (SAEs) and adverse events of special interest (AESI)
AE will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
Measured: Up to 2 years after CT120 CAR T-cells infusion
Phase 2:Overall response rate (ORR) at Day 90
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better at Day 90
Measured: Up to 90 Days after CT120 infusion
Secondary outcomes (11)
Overall response rate (ORR)
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better.
Measured: Up to Day 28、Day 90、Day180 after CT120 infusion
Time to Response (TTR)
Time from CT120 infusion to first documentation of response.
Measured: Up to 2 years after CT120 infusion
Time to complete Response (TTCR)
Time from CT120 infusion to first documentation of complete response.
Measured: Up to 2 years after CT120 infusion
Duration of Response (DOR)
Time from first response to disease progression or death from any cause
Measured: Up to 2 years after CT120 infusion
Progression-free Survival (PFS)
PFS will be calculated as the time from CT120 infusion to disease progression or death from any cause (whichever occurs first).
Measured: Up to 2 years after CT120 infusion
Overall Survival (OS)
Time from CT120 infusion to time of death due to any cause
Measured: Up to 2 years after CT120 infusion
Quantity of CAR copies in peripheral blood
CAR copies in peripheral blood will be measured by quantitative polymerase chain reaction (qPCR) in 2 years.
Measured: Up to 2 years after CT120 infusion
Quantity of CAR T-cells level in peripheral blood
CAR T-cells in peripheral blood will be measured by flow cytometry (FCM) in 2 years
Measured: Up to 2 years after CT120 infusion
Laboratory tests
Abnormal results of laboratory tests
Measured: Up to 2 years after CT120 infusion
Vital signs
Abnormal results of vital signs
Measured: Up to 2 years after CT120 infusion
Physical examination
Abnormal results of physical examination
Measured: Up to 2 years after CT120 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start20 Oct 2021 (estimated)
- Primary completion20 Oct 2024 (estimated)
- Study completion20 Oct 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Nanjing IASO Biotechnology Co., Ltd.The 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091541
- Sponsor's protocol ID
- CT120C001
- Status last verified
- Oct 2021
- First submitted
- 15 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I/II Clinical Study on Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection (CT120) for the Treatment of Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05091541
- Acronym / sponsor ID
- CT120C001
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Nanjing IASO Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (estimated)
- Primary completion
- 20 Oct 2024 (estimated)
- Study completion
- 20 Oct 2039 (estimated)
- First posted
- 25 Oct 2021 (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.
This study is a single-armed, open-label,multicenter Phase 1/2 study to evaluate the safety and efficacy of CT120 in subjects with relapsed/refractory B-cell non-Hodgkin's lymphoma.
Detailed description
Leukapheresis procedure will be performed to manufacture CT120. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide was performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of CT120. Subjects will be followed in the study for a minimum of 2 years after CT120 infusion. Long-term follow-up for lentiviral vector safety will be followed for up to 15 years after CT120 infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT120 in relapsed/refractory B-cell non-Hodgkin's lymphoma patients | Experimental | Drug: Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell InjectionFully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection（CT120）will be infused at 1.0 x 10^6 CAR+ T cells/kg、3.0 x 10^6 CAR+ T cells/kg、6.0 x 10^6 CAR+ T cells/kg in relapsed/refractory B-cell non-Hodgkin's lymphoma patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age between 18 and 70 years old.
- Pathologically confirmed B-cell non-Hodgkin's lymphoma, including:
- Diffuse large B-cell lymphoma (DLBCL); (2) Histopathological Grade 3b follicular lymphoma (FL3b); (3) Follicular lymphoma with diffuse large B cell transformation; (4) Primary mediastinal large B-cell lymphoma (PMBCL). 3. Relapsed/refractory B-cell non-Hodgkin's lymphoma must meet one of the following criteria:
- At least 2 failed prior B-cell non-Hodgkin's lymphoma treatment regimens (including relapse, no response, and progression). Prior therapy must have included anti-CD20 monoclonal antibodies (except for CD20-negative subjects) and standard therapies which including anthracyclines;
- Recurrence after autologous hematopoietic stem cell transplantation;
Key exclusion criteria (12 listed)
- Subjects who have received or require the following treatments:
- Prior CAR-T cell therapy before enrollment; (2) Presence of acute or chronic graft-versus-host disease (GVHD) requires systemic treatment within 4 weeks before enrollment; (3) History of immunodeficiency or other diseases and autoimmune diseases (eg Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) received immunosuppressive therapy within 2 years before enrollment; (4) Autologous hematopoietic stem cell transplantation (autoSCT) within 12 weeks before enrollment and history of allogeneic stem cell transplantation (HSCT); (5) Live vaccines injection within 4 weeks before enrollment; (6) According to investigator's discretion, there is a need to use systemic corticosteroid therapy within 12 weeks after the administration of the study drug (except for hydrocortisone ≤12mg/m2/day or other hormones converting into the same dose range for physiological replacement therapy) or other immunosuppressive drug therapy (except local therapy).
- 2. B-cell non-Hodgkin's lymphoma patients with active central nervous system or intestinal parenchyma invasion.
- 3. Excessive tumor burden and any lesions with a long axis ≥10cm. 4. Other active malignant tumors in the past 5 years, except for curable tumor that has been completely cured, such as basal or squamous cell carcinoma, cervical or breast carcinoma in situ, etc.
- 5. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and an abnormal HBV DNA result detected by peripheral blood test (abnormal HBV DNA result is defined as: the quantitative detection of HBV DNA is over the detectable lower limit or beyond the normal reference of the testing center or HBV viral DNA positive); Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA test positive; syphilis test positive.
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 |
|---|---|---|
| Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell InjectionAlso: CT120CT120 is an autologous CD19/22 targeted CAR-T cells injection. The dosage form is a cryopreserved injection solution. The T cells aphesis from subjects then been manufactured to express CAR to binding CD19 and CD22 on B-cell lymphoma. | Drug | CT120 in relapsed/refractory B-cell non-Hodgkin's lymphoma patients |
Primary outcome
Phase 1: Types and incidence of Dose-limiting toxicity (DLT)
Time frame: up to 28 days after CT120 infusion
Dose-limiting toxicity (DLT) will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
Phase 1:Types and incidence of adverse events (AEs) ，serious adverse events (SAEs) and adverse events of special interest (AESI)
Time frame: Up to 2 years after CT120 CAR T-cells infusion
AE will be collected and graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus (for CRS/ICANS) and CTCAE v5.0(for AE except CRS/ICANS)
Phase 2:Overall response rate (ORR) at Day 90
Time frame: Up to 90 Days after CT120 infusion
ORR will be calculated as the percentage of patients who achieved partial response (PR) or better at Day 90
11 secondary outcomes
Overall response rate (ORR)
Time frame: Up to Day 28、Day 90、Day180 after CT120 infusion
Time to Response (TTR)
Time frame: Up to 2 years after CT120 infusion
Time to complete Response (TTCR)
Time frame: Up to 2 years after CT120 infusion
Duration of Response (DOR)
Time frame: Up to 2 years after CT120 infusion
Progression-free Survival (PFS)
Time frame: Up to 2 years after CT120 infusion
Overall Survival (OS)
Time frame: Up to 2 years after CT120 infusion
Quantity of CAR copies in peripheral blood
Time frame: Up to 2 years after CT120 infusion
Quantity of CAR T-cells level in peripheral blood
Time frame: Up to 2 years after CT120 infusion
Laboratory tests
Time frame: Up to 2 years after CT120 infusion
Vital signs
Time frame: Up to 2 years after CT120 infusion
Physical examination
Time frame: Up to 2 years after CT120 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fully Human Anti-CD19/CD22 Dual Target Chimeric Antigen Receptor Autologous T Cell Injection in people with B-cell Non-Hodgkin's Lymphoma, run by Nanjing IASO Biotechnology Co., Ltd..
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 17 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: opening soon, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Wu (+86 0531-58287610, ming.wu@iasobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Types and incidence of Dose-limiting toxicity (DLT) (time frame: up to 28 days after CT120 infusion). The study lists 3 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 25 Oct 2021.