Recurrent or Refractory B Cell MalignancyPhase 1/2NCT02794961
CD22 Targeting CAR-T Therapy Against B Cell Hematological Malignancies
A Phase 1/2 study testing CD22 CAR-T in people with Recurrent or Refractory B Cell Malignancy, run by Kai Lin Xu; Jun Nian Zheng at 1 site in China.
Trial summary
CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue. Read more about this study
- Who is it for?
- Ages 4 to 60 years
- Conditions the study is for
- Recurrent or Refractory B Cell Malignancy
- What is being tested?
- CD22 CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Jun 2019
- Phase
- Phase 1/2
- 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 4 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Greater than four years of age
- Survival time>12 weeks
- B cell hematological malignancies by pathological examination
- Chemotherapy failure or recurrent B cell malignancy
- Creatinine< 2.5mg/dl
- Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
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- Bilirubin<2.0mg/dl
- Karnofsky Performance Status>50% at the time of screening
- Adequate pulmonary, renal, hepatic, and cardiac function
- Fail in autologous or allogenic haemopoietic stem cell transplantation
- Free of leukocytes removal contraindications
- Voluntarily join CAR-T clinical trial
- Understand and sign written informed consent
Who cannot join
- Pregnant or nursing women
- Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
- Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated.
- Abnormal vital signs
- Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
- General infection or local severe infection, or other infection that is not controlled
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- Dysfunction in lung, heart, kidney and brain
- Severe autoimmune diseases
- Other symptoms that are not applicable for CAR-T
Trial locations and contacts
1 site in 1 country.
JunNian Zheng, M.D., Ph.D. contact
China1 site, 1 recruiting
- Recruiting
Affiliated hospital of Xuzhou medical college
Xuzhou, Jiangsu, 221000
Jiang Cao, M.D., Ph.D.
About this study
Official title: Application of Humanized Anti-CD22 Antibody in CAR-T Therapy of B Cell Hematological Malignancies
CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.
Read the detailed description
CD19 is an ideal target with great potential for treating B-cell-derived hematological malignancies. Although the complete remission rate is as high as 93% by using CD19-targeting CAR-T technology, approximately 60% patients will have recurrent disease. Among all the recurrent patients, two thirds is revealed to loss their CD19 expression on B cell surface. For overcoming this issue, we establish a new chimeric antigen receptor containing humanized single chain antibody sequence to target CD22 molecule on B cells.
- Being tested
- CD22 CAR-T
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD22 CAR-TBiological
Autologous CAR-T cells with average 1*10^6 cells/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| CD22 CAR-T | Experimental | Enrolled patients will receive three escalating doses of autologous CAR-T. Receives: Biological: CD22 CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
The B cells in peripheral blood of all enrolled patients will be monitored every week
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent or Refractory B Cell MalignancyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Lin Xu; Jun Nian Zheng
- Sponsor type
- University, hospital or other
- Collaborators
- iCarTAB BioMed Inc.
- Responsible party
- Sponsor-investigator, Kai Lin Xu; Jun Nian Zheng, Xuzhou Medical University
- Investigators
- KaiLin Xu, MD. Ph.D., Principal investigator, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794961
- Sponsor's protocol ID
- AF-08/04.2
- Status last verified
- Jun 2016
- First submitted
- 6 Jun 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Haso W, Lee DW, Shah NN, Stetler-Stevenson M, Yuan CM, Pastan IH, Dimitrov DS, Morgan RA, FitzGerald DJ, Barrett DM, Wayne AS, Mackall CL, Orentas RJ. Anti-CD22-chimeric antigen receptors targeting B-cell precursor acute lymphoblastic leukemia. Blood. 2013 Feb 14;121(7):1165-74. doi: 10.1182/blood-2012-06-438002. Epub 2012 Dec 14.
PubMed 23243285
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Humanized Anti-CD22 Antibody in CAR-T Therapy of B Cell Hematological Malignancies
- ClinicalTrials.gov ID
- NCT02794961
- Acronym / sponsor ID
- AF-08/04.2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kai Lin Xu; Jun Nian ZhengUniversity, hospital or other
- Collaborators
- iCarTAB BioMed Inc.
- Study start
- Jun 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 9 Jun 2016 (estimated)
- 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.
CD19 expression on B cell frequently lost after CD19-targeting CAR-T therapy. In present study, we construct a CD22-targeting chimeric antigen receptor to overcome this issue.
Detailed description
CD19 is an ideal target with great potential for treating B-cell-derived hematological malignancies. Although the complete remission rate is as high as 93% by using CD19-targeting CAR-T technology, approximately 60% patients will have recurrent disease. Among all the recurrent patients, two thirds is revealed to loss their CD19 expression on B cell surface. For overcoming this issue, we establish a new chimeric antigen receptor containing humanized single chain antibody sequence to target CD22 molecule on B cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD22 CAR-T | Experimental | Biological: CD22 CAR-TEnrolled patients will receive three escalating doses of autologous CAR-T. |
Who may qualify
- Ages
- 4 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Greater than four years of age
- Survival time>12 weeks
- B cell hematological malignancies by pathological examination
- Chemotherapy failure or recurrent B cell malignancy
- Creatinine< 2.5mg/dl
Key exclusion criteria (9 listed)
- Pregnant or nursing women
- Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
- Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated.
- Abnormal vital signs
- Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
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 |
|---|---|---|
| CD22 CAR-TAutologous CAR-T cells with average 1*10^6 cells/kg body weight | Biological | CD22 CAR-T |
Primary outcome
Complete remission rate
Time frame: 12 months
The B cells in peripheral blood of all enrolled patients will be monitored every week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
- Results publication: PubMed 23243285Haso W, Lee DW, Shah NN, Stetler-Stevenson M, Yuan CM, Pastan IH, Dimitrov DS, Morgan RA, FitzGerald DJ, Barrett DM, Wayne AS, Mackall CL, Orentas RJ. Anti-CD22-chimeric antigen receptors targeting B-cell precursor acute lymphoblastic leukemia. Blood. 2013 Feb 14;121(7):1165-74. doi: 10.1182/blood-2012-06-438002. Epub 2012 Dec 14.
- Individual participant dataSharing planned: Yes
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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.
JunNian Zheng, M.D., Ph.D. contact
KaiLin Xu, MD. Ph.D. principal investigator
Xuzhou Medical University
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 CD22 CAR-T in people with Recurrent or Refractory B Cell Malignancy, run by Kai Lin Xu; Jun Nian Zheng 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 13 inclusion and 9 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 9 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Cao, M.D., Ph.D. (8651685802291, zimu05067@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02794961, which also lists 1 linked publication.
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 9 Jun 2016.