Refractory B-Cell Non-Hodgkin LymphomaPhase 1/2NCT03994913
Clinical Trial to Evaluate CD19 CAR T (CT032) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma
A Phase 1/2 study testing CAR-CD19 T Cells in people with Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed B-cell Non-Hodgkin Lymphoma, run by CARsgen Therapeutics Co., Ltd. at 2 sites in China.
Trial summary
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT032 CAR-CD19 T in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (R/R B-NHL). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed B-cell Non-Hodgkin Lymphoma
- What is being tested?
- CAR-CD19 T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 14 Aug 2019to 27 May 2021
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject should participate in the clinical trial voluntarily, be fully aware of and informed of this study and sign informed consent (ICF), and be willing to follow and be able to complete all trial procedures;
- Age 18-70 years old, male or female;
- CD 19 positive, Relapsed and/or Refractory Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma after the transformation of Relapsed and/or Refractory DLBCL subjects by histopathological and/or cytology diagnosis; At least received second-line systemic anticancer treatments containing rituximab (or other anti-CD20 drugs) and anthracene (including autologous hematopoietic stem cell transplantation) , and had progressive disease (PD) or relapse after the latest treatment.
- The Eastern Cooperative Oncology Group (ECOG) score is 0 or 1 point;
- The expected survival period is more than 12 weeks;
- Having sufficient venous pathways (for leukapheresis or intravenous blood collection) and no leukapheresis contraindications;
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- At least one measurable lesion: the long axis >1.5 cm of the lymph node lesion, or the long axis >1.0 cm of the non-lymph node lesion;
- subject has adequate organ function at screening;
- Women of childbearing age must undergo a serum pregnancy test with negative results before screening and lymphodepletion preconditioning with fludarabine and cyclophosphamide, and are willing to use effective and reliable method of contraception for at least 1 year after T cell infusion;
- Male subjects who have an active sex life with a woman with reproductive potential must be willing to use very effective and reliable methods of contraception for at least 1 year after T cell infusion.
Who cannot join
- If the subject meets any of the following criteria, he or she cannot participate in this trial:
- A history of severe allergies, or a history of allergies or intolerance to fludarabine, cyclophosphamide or tocilizumab, or a history of allergies or intolerance to CAR T cell cytosolic component, or a history of allergic to beta-caprolactam antibiotics;
- Received chemotherapy, targeted therapy, radiotherapy and other anti-tumor treatment within 14 days before peripheral blood mononuclear cells (PBMCs) collection;
- Previously received any target of CAR T treatment, or previously received CD19 targeted drug treatment;
- Has undergone allogeneic hematopoietic stem cell transplantation; autologous stem cell transplantation was received within 12 weeks before PBMCs collection;
- Other malignant neoplasms existed in the previous 5 years or at the same time, with the exception of breast/cervical in situ cancer, cured basal cell carcinoma and superficial bladder tumor (Ta, Tis, T1);
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- Any uncontrollable active infection, including but not limited to active TB patients
- subjects who had received a therapeutic dose of systemic steroid drugs (prednisone >20mg/days or equivalent doses of other hormones) or other immunosuppressants within 7 days before PBMCs collection, with the exception of those who had recently or currently used inhaled steroids;
- Known to have active autoimmune diseases, including but not limited to psoriasis, rheumatoid arthritis, etc., that need long-term immunosuppressive therapy;
- Patients with refractory hyponatremia and/or hypokalemia;
- Known or existing primary or metastatic central nervous system lymphoma, or any other central neurological disease or clinically significant neurological examination with abnormal results (such as seizures, cerebrovascular ischemia/hemorrhage, dementia, etc.);
- Within 6 months prior to signing the ICF, there were any of the uncontrolled cardiovascular, cerebral vascular disease, diabetes and pulmonary embolism, or other disease at discretion of investigators that participating in this clinical trial may harm the health of the subjects;
- Oxygen absorption before PBMCs collection to maintain blood oxygen saturation >95% (finger vein oxygen);
- According to the investigator, any serious or uncontrollable systemic disease, systematic comorbidities, other serious concurrent diseases (such as hemophagocytic syndrome, etc.), special circumstances of the tumor may make the subjects inappropriate to enter the study or non-compliant to the protocol, or produce significant interference to correct evaluation of study drug safety, toxicity, and validity;
- The investigators assessed that the subjects were unable or unwilling to comply with the requirements of the research protocol;
- Major surgical operations were performed within 4 weeks of the group (the definition of major surgery is based on the 3 and 4 levels of surgery specified in the measures for the administration of clinical application of medical technology); or has not yet been fully recovered from any previous invasive operation;
- The toxic response of previous anti-tumor therapy has not been restored to level 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), except for hair loss and;
- Having participated in any other interventional clinical trial before administration, where the last time of drug administration is within 4 weeks or less than 5 half-lives of the test drug (the longer);
- Women who have been pregnant, prepared for pregnancy during the trial, or are breastfeeding; or women of childbearing age and fertile men who are unwilling or unable to adopt medically recognized and effective contraceptive methods throughout the study period;
- The investigator or a relative of his staff, a subject who may have an interest in it with the investigator or his staff.
Trial locations and contacts
2 sites in 1 country.
China2 sites
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: An Open, Multi-center Phase Ⅰ/II Clinical Study to Evaluate the Safety and Efficacy of CT032 Humanized CD19 Autologous Car T Cell Injection in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT032 CAR-CD19 T in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (R/R B-NHL).
Read the detailed description
This study is a single-arm, open label, phase I/II clinical trial to evaluate the safety, efficacy and cellular kinetics of CT032 CAR-CD19 T cells in patients with R/R B-NHL. The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to verify the efficacy and safety of the dose proposed.
- Being tested
- CAR-CD19 T Cells
- Keywords
- Relapsed and/or Refractory B-cell Non-Hodgkin Lymphoma, CAR T
- 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.
CAR-CD19 T CellsBiological
The CAR- CD19 T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting CD19.
Fludarabine and Cyclophosphamide are used for lymphodepletion.
| Study group | Role | What they receive |
|---|---|---|
| CAR-CD19-T Cells | Experimental | The subjects are enrolled into 3 dose levels cohorts in sequence. Receives: Biological: CAR-CD19 T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ⅰ, Safety/Tolerability: Dose-limiting toxicity (DLT)
Dose-limiting toxicity (DLT)
Measured: 28 days post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD)
Measured: 28 days post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Incidence and severity of Treatment emergent adverse events (TEAE)
Measured: 28 days post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE
Incidence and severity of AE related to study treatment
Measured: through 2 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES])
Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES])
Measured: through 2 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment
Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment
Measured: 28 days after infusion
Phase Ⅰ, Safety/Tolerability: Recommended Phase II Dose (RP2D)
Recommended Phase II Dose (RP2D)
Measured: through 2 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: Overall Remission Rate (ORR)
Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)
Measured: through 6 months post administration of CAR-T cells
Secondary outcomes (15)
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Incidence and severity of Treatment emergent adverse events (TEAE)
Measured: through 24 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE
Incidence and severity of AE related to study treatment
Measured: through 24 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Measured: through 24 months post administration of CAR-T-cells
Phase Ⅰ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
Measured: through 24 months post administration of CAR-T cells
Phase Ⅰ, Efficacy: Overall Remission Rate (ORR)
Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: complete response (CR) rate
complete response (CR) rate
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: duration of response (DOR)
duration of response (DOR)
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: time to response (TTR)
time to response (TTR)
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: progression-free survival (PFS)
progression-free survival (PFS) time
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: overall survival (OS)
overall survival (OS) time
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Incidence and severity of Treatment emergent adverse events (TEAE)
Measured: through 24 months post administration of CAR-T cells
Incidence and severity of o study treatment related AE
Incidence and severity of AE related to study treatment
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Incidence and severity of AEs of special interest (CRS, CRES)
Incidence and severity of AEs of special interest (CRS, CRES)
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Measured: through 24 months post administration of CAR-T cells
Phase Ⅱ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
Measured: through 24 months post administration of CAR-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start14 Aug 2019
- Primary completion20 Jan 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory B-Cell Non-Hodgkin 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Jin, Dr., Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994913
- Sponsor's protocol ID
- CT032-NHL-01
- Status last verified
- Apr 2023
- First submitted
- 12 Jun 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-center Phase Ⅰ/II Clinical Study to Evaluate the Safety and Efficacy of CT032 Humanized CD19 Autologous Car T Cell Injection in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03994913
- Acronym / sponsor ID
- CT032-NHL-01
- Keywords
- Relapsed and/or Refractory B-cell Non-Hodgkin Lymphoma, CAR T
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CARsgen Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- First Affiliated Hospital of Zhejiang University, RenJi Hospital
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 21 Jun 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 an open-label, single arm study to evaluate the safety and tolerability of treatment with CT032 CAR-CD19 T in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (R/R B-NHL).
Detailed description
This study is a single-arm, open label, phase I/II clinical trial to evaluate the safety, efficacy and cellular kinetics of CT032 CAR-CD19 T cells in patients with R/R B-NHL. The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to verify the efficacy and safety of the dose proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-CD19-T Cells | Experimental | Biological: CAR-CD19 T CellsThe subjects are enrolled into 3 dose levels cohorts in sequence. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject should participate in the clinical trial voluntarily, be fully aware of and informed of this study and sign informed consent (ICF), and be willing to follow and be able to complete all trial procedures;
- Age 18-70 years old, male or female;
- CD 19 positive, Relapsed and/or Refractory Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma after the transformation of Relapsed and/or Refractory DLBCL subjects by histopathological and/or cytology diagnosis; At least received second-line systemic anticancer treatments containing rituximab (or other anti-CD20 drugs) and anthracene (including autologous hematopoietic stem cell transplantation) , and had progressive disease (PD) or relapse after the latest treatment.
- The Eastern Cooperative Oncology Group (ECOG) score is 0 or 1 point;
- The expected survival period is more than 12 weeks;
Key exclusion criteria (20 listed)
- If the subject meets any of the following criteria, he or she cannot participate in this trial:
- A history of severe allergies, or a history of allergies or intolerance to fludarabine, cyclophosphamide or tocilizumab, or a history of allergies or intolerance to CAR T cell cytosolic component, or a history of allergic to beta-caprolactam antibiotics;
- Received chemotherapy, targeted therapy, radiotherapy and other anti-tumor treatment within 14 days before peripheral blood mononuclear cells (PBMCs) collection;
- Previously received any target of CAR T treatment, or previously received CD19 targeted drug treatment;
- Has undergone allogeneic hematopoietic stem cell transplantation; autologous stem cell transplantation was received within 12 weeks before PBMCs collection;
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 |
|---|---|---|
| CAR-CD19 T CellsThe CAR- CD19 T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting CD19. Fludarabine and Cyclophosphamide are used for lymphodepletion. | Biological | CAR-CD19-T Cells |
Primary outcome
Phase Ⅰ, Safety/Tolerability: Dose-limiting toxicity (DLT)
Time frame: 28 days post administration of CAR-T cells
Dose-limiting toxicity (DLT)
Phase Ⅰ, Safety/Tolerability: Maximum tolerated dose (MTD)
Time frame: 28 days post administration of CAR-T cells
Maximum tolerated dose (MTD)
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Time frame: 28 days post administration of CAR-T cells
Incidence and severity of Treatment emergent adverse events (TEAE)
Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE
Time frame: through 2 months post administration of CAR-T cells
Incidence and severity of AE related to study treatment
Phase Ⅰ, Safety/Tolerability: Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES])
Time frame: through 2 months post administration of CAR-T cells
Incidence and severity of AEs of special interest (cytokine release syndrome [CRS], CART-cell-related encephalopathy syndrome [CRES])
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment
Time frame: 28 days after infusion
Incidence and severity of Dose-limiting toxicity (DLT) of dose escalation experiment
Phase Ⅰ, Safety/Tolerability: Recommended Phase II Dose (RP2D)
Time frame: through 2 months post administration of CAR-T cells
Recommended Phase II Dose (RP2D)
Phase Ⅱ, Efficacy: Overall Remission Rate (ORR)
Time frame: through 6 months post administration of CAR-T cells
Overall Remission Rate (ORR) (Partial remission and complete remission rate after infusion of CT032 CAR-CD19 T cells)
15 secondary outcomes
Phase Ⅰ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Incidence and severity of study treatment related AE
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅰ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Time frame: through 24 months post administration of CAR-T-cells
Phase Ⅰ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅰ, Efficacy: Overall Remission Rate (ORR)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: complete response (CR) rate
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: duration of response (DOR)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: time to response (TTR)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: progression-free survival (PFS)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Efficacy: overall survival (OS)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Incidence and severity of Treatment emergent adverse events (TEAE)
Time frame: through 24 months post administration of CAR-T cells
Incidence and severity of o study treatment related AE
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Incidence and severity of AEs of special interest (CRS, CRES)
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ, Safety/Tolerability: Cytokine (IL-2, IL-6,IL-8,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by MSD and CBA method
Time frame: through 24 months post administration of CAR-T cells
Phase Ⅱ: the number of copies of CAR-CD19 T cells in peripheral blood genomes by qPCR method and CAR-CD19 T cells by flow cytometry method
Time frame: through 24 months post administration of CAR-T cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Jie Jin, Dr. principal investigator
First Affiliated Hospital of Zhejiang University
2 sites 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 CAR-CD19 T Cells in people with Refractory B-Cell Non-Hodgkin Lymphoma and Relapsed B-cell Non-Hodgkin Lymphoma, run by CARsgen Therapeutics Co., Ltd. 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 10 inclusion and 20 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: finished, as of the sponsor's last update on 14 Apr 2023. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ⅰ, Safety/Tolerability: Dose-limiting toxicity (DLT) (time frame: 28 days post administration of CAR-T cells). The study lists 8 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 14 Apr 2023.