B Cell LymphomaEarly Phase 1NCT04156243
CD19 CARvac T Cells for Patients With Relapsed / Refractory B Cell Malignancies
A Early Phase 1 study testing CD19 CARvac T cells in people with B Cell Lymphoma and B Cell Leukemia, run by iCell Gene Therapeutics at 2 sites in China.
Trial summary
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- B Cell Lymphoma, B Cell Leukemia
- What is being tested?
- CD19 CARvac T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2018to 28 Feb 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis based on the World Health Organization (WHO) 2008
- Patients have exhausted standard therapeutic options
- Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
- Female must be not pregnant during the study
Who cannot join
- Prior solid organ transplantation
- Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The General Hospital of Western Theater Command
Chengdu
Fang Liu, MD, PhD
lfyh2006@yahoo.com
- Recruiting
Peking University Shenzhen Hospital
Shenzhen
Hongyu Zhang, MD, PhD
HongyuZhang@pkuszh.com
About this study
Official title: Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD19 CARvac in Patients With Relapsed and/or Refractory B Cell Malignancies
This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.
Read the detailed description
CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat
- Conditions
- B Cell Lymphoma, B Cell Leukemia
- Being tested
- CD19 CARvac T cells
- Keywords
- CD19, CD19 CAR T cell
- Medical subject headings
- Lymphoma, B-Cell, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CARvac T cellsBiological
CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| CD19 CARvac T cells | Experimental | CD19 CARvac T cells transduced with a lentiviral vector to express Receives: Biological: CD19 CARvac T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 28 days
Type of dose-limiting toxicity (DLT)
Measured: 28 days
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 2 years
Secondary outcomes (3)
Overall Response Rate (ORR)
Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies
Measured: 1 year
Progression-free survival (PFS)
Measured: 1 year
Overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Feb 2018
- Primary completion28 Feb 2020 (estimated)
- Study completion28 Feb 2020 (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 B Cell 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iCell Gene Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Shenzhen Hospital, Chengdu Military General Hospital, iCAR Bio Therapeutics Ltd.
- Responsible party
- Sponsor
- Investigators
- Hongyu Zhang, MD, PhD, Principal investigator, Peking University Shenzhen HospitalFang Liu, MD, PhD, Principal investigator, The General Hospital of Western Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156243
- Sponsor's protocol ID
- ICG134-001
- Status last verified
- Jan 2019
- First submitted
- 6 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu F, Sha S, Ma G, Su Y, Xiong Y, He G, Li Y, Hanes WM, Tse W. Treatment of CML-transformed B Cell Acute Lymphoblastic Leukemia (B-ALL) in Adults with Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy. Stem Cell Rev Rep. 2020 Dec;16(6):1356-1358. doi: 10.1007/s12015-020-10008-7. No abstract available.
PubMed 32840736
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of CD19 CARvac in Patients With Relapsed and/or Refractory B Cell Malignancies
- ClinicalTrials.gov ID
- NCT04156243
- Acronym / sponsor ID
- ICG134-001
- Conditions
- B Cell Lymphoma, B Cell Leukemia
- Keywords
- CD19, CD19 CAR T cell
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- iCell Gene TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Peking University Shenzhen Hospital, Chengdu Military General Hospital, iCAR Bio Therapeutics Ltd.
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 7 Nov 2019 (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 is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD19 CARvac in patients with relapsed and/or refractory B cell malignancies.
Detailed description
CD19 CARvac is a chimeric antigen receptor immunotherapy treatment designed to treat
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 CARvac T cells | Experimental | Biological: CD19 CARvac T cellsCD19 CARvac T cells transduced with a lentiviral vector to express |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis based on the World Health Organization (WHO) 2008
- Patients have exhausted standard therapeutic options
- Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
- Female must be not pregnant during the study
Key exclusion criteria (3 listed)
- Prior solid organ transplantation
- Potentially curative therapy including chemotherapy or hematopoietic cell transplant
- Prior treatment with BCMAxCD3 or CS1xCD3 bispecific agents
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 |
|---|---|---|
| CD19 CARvac T cellsCD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy. | Biological | CD19 CARvac T cells |
Primary outcome
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 28 days
Type of dose-limiting toxicity (DLT)
Time frame: 28 days
Number of participants with adverse event by severity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: 2 years
3 secondary outcomes
Overall Response Rate (ORR)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 1 year
Overall survival
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Derived from this study: PubMed 32840736Liu F, Sha S, Ma G, Su Y, Xiong Y, He G, Li Y, Hanes WM, Tse W. Treatment of CML-transformed B Cell Acute Lymphoblastic Leukemia (B-ALL) in Adults with Anti-CD19 Chimeric Antigen Receptor T Cell (CAR T) Therapy. Stem Cell Rev Rep. 2020 Dec;16(6):1356-1358. doi: 10.1007/s12015-020-10008-7. No abstract available.
- Individual participant dataSharing planned: No
Related trials for B Cell Lymphoma
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
RecruitingObservational study
An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
RecruitingPhase 1
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
RecruitingPhase 3
A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia
B-cell Acute Lymphoblastic Leukemia
Not yet recruiting
Busulfan-Based Versus TBI-Based Conditioning for Adult ALL-CR2 Allo-HSCT
Acute Lymphoblastic Leukemia, Hematopoietic Stem Cell Transplantation
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.
Hongyu Zhang, MD, PhD principal investigator
Peking University Shenzhen Hospital
Fang Liu, MD, PhD principal investigator
The General Hospital of Western Theater Command
2 sites 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 CD19 CARvac T cells in people with B Cell Lymphoma and B Cell Leukemia, run by iCell Gene Therapeutics at 2 sites 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 4 inclusion and 3 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 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Kevin Pinz (6315386218, kevin.pinz@icellgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicity (DLT) as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: 28 days). 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?
On the ClinicalTrials.gov record for NCT04156243, 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 12 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.