LymphomaPhase 1/2NCT05948033
CD70 Targeted CAR-T Cells in CD70 Positive Relapsed/Refractory Lymphoma
A Phase 1/2 study testing CD70-targeting CAR-T cells in people with Lymphoma, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive Relapsed/Refractory Lymphoma . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- CD70-targeting CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2023to 31 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients eligible for inclusion in this study had to meet all of the following criteria:
- Age 18-75 (inclusive);
- ECOG performance status ≤2 and Estimated life expectancy of more than 3 months;
- Patients with histologically confirmed lymphoma including the following types defined by the World Health Organization(WHO) 2016:HL,Aggressive B-cell non-Hodgkin's lymphoma(Diffuse large B-cell lymphoma,High grade B-cell lymphoma,burkitt's lymphoma,Mantle cell lymph,Anaplastic large cell lymphoma, etc.) and Indolent lymphoma（Including but not limited to follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, etc.）
- Relapse after treatment with ≥2 lines systemic therapy for all the above disease types. Relapse disease is defined as disease progression after last regimen. Refractory disease is defined as no CR tofirst-line therapy:
- PD as best response to first-line therapy, or
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- SD as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R- CHOP), or
- PR as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 6 months of therapy, or
- Refractory post-autologous stem cell transplant (ASCT) i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy prove recurrence in relapsed individuals) ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy.
- Individuals must have received adequate prior therapy.
- CD70 antigen expression percentage ≥ 10%.
- Successful leukapheresis assessment and preculture of T cells;
- According to Lugano response criteria 2014, there should be at least one evaluable tumor focus. Evaluable tumor focus was defined as that with the longest diameter of intranodal focus > 1.5cm, the longest diameter of extranodal focus > 1.0cm assessed by computed tomography (CT) ormagnetic resonance imaging (MRI).
- Functions of important organs meet the following requirements:ANC≥≥1×10^9/L; Platelet count ≥50×10^9/L; Hemoglobin ≥80 g/L;Serum AST and serum ALT, ≤3.0 x ULN (≤5 x ULN for patients with liver metastases); Total serum bilirubin ≤3.0 x ULN); Serum creatinine ≤1.5xULN ; Echocardiography showed left ventricular ejection fraction ≥50%.Pulmonary function: oxygen saturation of blood (SaO2) ≥92% in indoor air environment.
- Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion/exclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).
- Pregnancy tests for women of childbearing age shall be negative;Both men and women agreed to use effective contraception during treatment and during the subsequent 1 year.
- Ability to understand and sign a written informed consent documen.
Who cannot join
- Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- Received cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives before enrollment;
- Pregnant, lactating, or breastfeeding females;
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS);Active infection of hepatitis B virus (HBV), or hepatitis C virus (HCV);
- History of allergy or intolerance to study drug components;
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- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
- Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered.
- Known brain metastases or active central nervous system(CNS) has been involved
- Previous or concurrent cancer within 5 years prior to treatment start except for curatively treated cervical cancer in situ, non-melanoma skin cancer, local prostate cancer after radical surgery ;
- Any serious underlying medical (eg, pulmonary, renal,hepatic,gastrointestinal, or neurological) or psychiatric condition or any issue that would limit compliance with study requirements;
- Vaccination within 30 days of study enrollment;
- Previously received targeting CD70 therapy;
- Being participating any other trials or withdraw within 4 weeks;
- Researchers believe that other reasons are not suitable for clinicaltrials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China
Beijing, Biotherapeutic Department of Chinsese PLA Gereral Hospital
Weidong Han, Ph.D, 010-66937231, hanwdrsw@sina.com
Yang Liu, M.D, 010-66939460, liuyang301blood@163.com
About this study
Official title: Phase I/II Study of CD70 Targeted CAR-T Cell Treatment in CD70 Positive Relapsed/Refractory Lymphoma
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive Relapsed/Refractory Lymphoma . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Read the detailed description
CAR-T cell therapy has been identified as a breakthrough therapy in hematologic malignancies,especially anti-CD19 CAR-T cell therapy in the treatment of r/r B-NHL has achieved remarkable efficacy.However, relapse with CD19-negative tumor after treatment with anti-CD19 CAR-T cells has been reported in different types of B-cell lymphoid malignancies, with a percentage up to 38% in patients with non-Hodgkin lymphoma (NHL).At present, the CAR-T cell treatment for HL is mainly confined to CD30 antigen,with an objective response rate (ORR) only 38%~62%. Therefore, a more effective treatment strategy is needed for these patients.
CD70, the membrane-binding ligand of the CD27 (a tumor necrosis factor receptor superfamily), has been reported to mediate tumour cell proliferation and be expressed on the malignant cells of diffuse large B-cell lymphoma (DLBCL)，mantle cell lymphoma (MCL) and follicular lymphomas (FL), as well as Hodgkin lymphoma, etc,but rarely on normal B cells or T cells,indicating CD70 targeted treament has emerged as potentialnovel immunotherapeutic strategy.Preclinical study demonstrated CD70-CAR-T cells represent a new therapeutic option for the treatment of patients with CD19-negative recurrence of lymphoma.Based on the preclinical data, we conduct this clinical trial in order to test the the safety profiles and anti-tumor activities of CD70-CAR-T cells in vivo. In dose escalation period, at least 12 eligible patients will be enrolled and receive 3 doses of CD70-CAR-T cell therapy (1 × 10^6 cells/kg, 3 × 10^6 cells/kg, 1 × 10^7 cells/kg) according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell infusion at dose of RP2D, which is determined by data from dose escalation period, including occurrence of dose limiting toxicities(DLT), pharmacokinetics/pharmacodynamics, efficacy and other parameters, to furtherly evaluate the safety and efficacy profiles of CD70-CAR-T cell therapy.
- Conditions
- Lymphoma
- Being tested
- CD70-targeting CAR-T cells
- Keywords
- CD70, Relapsed/Refractory
- Medical subject headings
- Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD70-targeting CAR-T cellsBiological
Dose escalation:
Dose1 (1×10^6 cells/kg) ,Dose 2(3×10^6 cells/kg) ,Dose 3 (1×10^7 cells/kg)
Doseexpansion: RP2D
Drug: Fludarabine
Intravenous fludarabine 25-30 mg/m^2/day on days 5, -4, and -3.
Drug: Cyclophosphamide
Intravenous cyclophosphamide 300-500 mg/m^2/day on days -5, -4, and -3.
| Study group | Role | What they receive |
|---|---|---|
| CD70-targeting CAR-T cells | Experimental | Enrolled participants will be given a preconditioning regimen consisted of fludarabine and cyclophosphamide before the infusion of CD70-CAR T cells.
Enrolled patients in this arm will be administered CD70-CAR T cells in 3+3 based escalation manner. Receives: Biological: CD70-targeting CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related adverse events（AEs）
AE is defined as any adverse medical event from the date of randomization to 12 months after CD70-CAR-T cells infusion. Among them, CRS and ICANS were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0.
Measured: Up to 12 months since the initiation of CD70-CAR-T cell therapy.
Incidence of dose limiting toxicities (DLTs)
DLT was defined as CD70-CAR-T cells-related events with onset within first 28 days following infusion:
Thedevelopment of Grade (G) 3 or higher grade CRS lasting > 2 weeks; All G4 non-hematologic toxicities.
Measured: Up to 28 days since the initiation of CD70-CAR-T cell therapy
Maximum tolerated dose (MTD)
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
Measured: Up to 28 days since the initiation of CD70-CAR-T cell therapy
Secondary outcomes (7)
Number and copy number of CD70-CAR-T cells
Number and copy number of CD70-CAR-T cells are evaluated by number in peripheral blood and tumor tissue.
Measured: Up to 3 years
Objective response rate (ORR)
The incidence of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or unevaluable (UE) as the best response to treatment assessed by investigators and based on the Lugano 2014.
assessment criterion
Measured: Up to 3 years
Progression Free Survival (PFS)
Progression Free Survival is defined as the time from the initiation of CD70-CAR-T cell therapy to documented disease progression or death.
Measured: Up to 3 years
Time to response (TTR)
TTR is defined as the time from CD70-CAR-T cell infusion to first assessed CR or PR by investigators and based on the Lugano 2014 assessment criterion.
Measured: Up to 3 years
Duration of response (DOR)
Duration of response is defined as the time from objective response until documented tumor progression among responders.
Measured: Up to 3 years
Overall Survival (OS)
Overall Survival is defined as the time from the initiation of CD70-CAR-T cell therapy to documented disease progression or death.
Measured: Up to 3 years
Pharmacodynamics: Peak level of cytokines in serum (phase 1 and phase 2)
The cytokines mainly include interleukin-2 (IL-2 ), IL-6, IL-8, IL-10, tumor necrosis factor-α (TNF-α), C reactive protein (CRP), ferritin. Peak was defined as the maximum post-baseline level of the cytokine.
Measured: Up to 28 days since the initiation of CD70-CAR-T cell therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start15 Jul 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UTC Therapeutics Inc.
- Responsible party
- Principal investigator, Han weidong, Chinese PLA General Hospital
- Investigators
- Yangbin Zhao, Ph.D, Study director, UTC Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948033
- Sponsor's protocol ID
- CHN-PLAGH-BT-081
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2023
- Last updated
- 17 Jul 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 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of CD70 Targeted CAR-T Cell Treatment in CD70 Positive Relapsed/Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT05948033
- Acronym / sponsor ID
- CHN-PLAGH-BT-081
- Conditions
- Lymphoma
- Keywords
- CD70, Relapsed/Refractory
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- UTC Therapeutics Inc.
- Study start
- 15 Jul 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jul 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.
In this single-center, single-arm,prospective, open-label, phase 1/2 study, the safety and efficacy of autologous CD70 targeted chimeric antigen receptor modified T (CAR-T) cell therapy will be evaluated in patients with CD70 antigen positive Relapsed/Refractory Lymphoma . In this clinical trial, at least 12 eligible patients in dose escalation period will be enrolled to receive 3 doses of CD70-CAR cell therapy according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell therapy at dose of recommended phase 2 dose(RP2D).
Detailed description
CAR-T cell therapy has been identified as a breakthrough therapy in hematologic malignancies,especially anti-CD19 CAR-T cell therapy in the treatment of r/r B-NHL has achieved remarkable efficacy.However, relapse with CD19-negative tumor after treatment with anti-CD19 CAR-T cells has been reported in different types of B-cell lymphoid malignancies, with a percentage up to 38% in patients with non-Hodgkin lymphoma (NHL).At present, the CAR-T cell treatment for HL is mainly confined to CD30 antigen,with an objective response rate (ORR) only 38%~62%. Therefore, a more effective treatment strategy is needed for these patients.
CD70, the membrane-binding ligand of the CD27 (a tumor necrosis factor receptor superfamily), has been reported to mediate tumour cell proliferation and be expressed on the malignant cells of diffuse large B-cell lymphoma (DLBCL)，mantle cell lymphoma (MCL) and follicular lymphomas (FL), as well as Hodgkin lymphoma, etc,but rarely on normal B cells or T cells,indicating CD70 targeted treament has emerged as potentialnovel immunotherapeutic strategy.Preclinical study demonstrated CD70-CAR-T cells represent a new therapeutic option for the treatment of patients with CD19-negative recurrence of lymphoma.Based on the preclinical data, we conduct this clinical trial in order to test the the safety profiles and anti-tumor activities of CD70-CAR-T cells in vivo. In dose escalation period, at least 12 eligible patients will be enrolled and receive 3 doses of CD70-CAR-T cell therapy (1 × 10^6 cells/kg, 3 × 10^6 cells/kg, 1 × 10^7 cells/kg) according to the "3+3" principle. In dose expansion period, additional at most 21 eligible patients will be enrolled to receive CD70-CAR-T cell infusion at dose of RP2D, which is determined by data from dose escalation period, including occurrence of dose limiting toxicities(DLT), pharmacokinetics/pharmacodynamics, efficacy and other parameters, to furtherly evaluate the safety and efficacy profiles of CD70-CAR-T cell therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD70-targeting CAR-T cells | Experimental | Biological: CD70-targeting CAR-T cellsEnrolled participants will be given a preconditioning regimen consisted of fludarabine and cyclophosphamide before the infusion of CD70-CAR T cells. Enrolled patients in this arm will be administered CD70-CAR T cells in 3+3 based escalation manner. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18-75 (inclusive);
- ECOG performance status ≤2 and Estimated life expectancy of more than 3 months;
- Patients with histologically confirmed lymphoma including the following types defined by the World Health Organization(WHO) 2016:HL,Aggressive B-cell non-Hodgkin's lymphoma(Diffuse large B-cell lymphoma,High grade B-cell lymphoma,burkitt's lymphoma,Mantle cell lymph,Anaplastic large cell lymphoma, etc.) and Indolent lymphoma（Including but not limited to follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia, etc.）
- Relapse after treatment with ≥2 lines systemic therapy for all the above disease types. Relapse disease is defined as disease progression after last regimen. Refractory disease is defined as no CR tofirst-line therapy:
- CD70 antigen expression percentage ≥ 10%.
Key exclusion criteria (15 listed)
- Subjects are being treated with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment.
- Received cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives before enrollment;
- Pregnant, lactating, or breastfeeding females;
- Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
- Known positive test result for human immunodeficiency virus (HIV) oracquired immune deficiency syndrome (AIDS);Active infection of hepatitis B virus (HBV), or hepatitis C virus (HCV);
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 |
|---|---|---|
| CD70-targeting CAR-T cellsDose escalation: Dose1 (1×10^6 cells/kg) ,Dose 2(3×10^6 cells/kg) ,Dose 3 (1×10^7 cells/kg) Doseexpansion: RP2D Drug: Fludarabine Intravenous fludarabine 25-30 mg/m^2/day on days 5, -4, and -3. Drug: Cyclophosphamide Intravenous cyclophosphamide 300-500 mg/m^2/day on days -5, -4, and -3. | Biological | CD70-targeting CAR-T cells |
Primary outcome
Incidence of treatment related adverse events（AEs）
Time frame: Up to 12 months since the initiation of CD70-CAR-T cell therapy.
AE is defined as any adverse medical event from the date of randomization to 12 months after CD70-CAR-T cells infusion. Among them, CRS and ICANS were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0.
Incidence of dose limiting toxicities (DLTs)
Time frame: Up to 28 days since the initiation of CD70-CAR-T cell therapy
DLT was defined as CD70-CAR-T cells-related events with onset within first 28 days following infusion: Thedevelopment of Grade (G) 3 or higher grade CRS lasting > 2 weeks; All G4 non-hematologic toxicities.
Maximum tolerated dose (MTD)
Time frame: Up to 28 days since the initiation of CD70-CAR-T cell therapy
MTD is defined as the highest dose level of less than or equal to 2 DLT among the 6 subjects finally determined.
7 secondary outcomes
Number and copy number of CD70-CAR-T cells
Time frame: Up to 3 years
Objective response rate (ORR)
Time frame: Up to 3 years
Progression Free Survival (PFS)
Time frame: Up to 3 years
Time to response (TTR)
Time frame: Up to 3 years
Duration of response (DOR)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Pharmacodynamics: Peak level of cytokines in serum (phase 1 and phase 2)
Time frame: Up to 28 days since the initiation of CD70-CAR-T cell therapy
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 17 Jul 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.
Yangbin Zhao, Ph.D study director
UTC Therapeutics Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD70-targeting CAR-T cells in people with Lymphoma, run by Chinese PLA General 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 17 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 Jul 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 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 Weidong Han, Ph.D (010-66937231 ext. +86, hanwdrsw@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment related adverse events（AEs） (time frame: Up to 12 months since the initiation of CD70-CAR-T cell therapy.). 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 17 Jul 2023.