Diffuse Large B-cell LymphomaPhase 1NCT04026100
CTA101 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
A Phase 1 study testing CTA101 in people with Diffuse Large B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of CTA101 in relapsed or refractory diffuse large B-cell lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- CTA101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Dec 2022
- Phase
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of DLBCL per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL and PMBCL transformed from follicular lymphoma;
- Relapsed or refractory DLBCL (meeting one of the following conditions):
- Recurrence, progression or stable disease (SD) after treatment with second-line or above second-line chemotherapy regimens;
- Recurrence or progression after autologous hematopoietic stem cell transplantation;
- At least one measurable lesion must be ≥ 1.5cm in the longest diameter;
- Male or female aged 18-70 years;
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- Estimated survival time ≥ 12 weeks;
- Serum albumin ≥ 30g/L, total bilirubin ≤ 25.7umol/L, creatinine ≤ 132.6umol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) <3 times of upper limit of normal;
- Absolute neutrophil count ≥ 1.0*10^9/L, platelet count ≥ 50*10^9/L;
- ECOG performance status 0 to 1;
- Echocardiographic diagnosis shows left ventricular ejection fraction (LVEF) ≥ 50%;
- No active infection in the lungs;
- Latest treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatment) must have been completed at least 2 weeks prior to screening;
- All women of child-bearing potential must have a negative blood or urine pregnancy test at screening, and agree to take medically acceptable contraception measures while on study treatment;
- Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Who cannot join
- History of hypersensitivity to any component of cell product;
- Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
- Recurrence after allogeneic hematopoietic stem cell transplantation;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis), or currently receiving antibiotic therapy by intravenous drip. However, prophylactic antibiotic, antiviral and antifungal treatments are allowed;
- HBV DNA copy number detected by PCR in patients with active hepatitis B is > 1000 at screening (if HBsAg positive, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection;
- Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency (see Appendix 1);
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- Patients with Corrected QT interval(QTc)>450 msecs (Fridericia formula);
- Patients with a history of epilepsy;
- Intracranial extranodal lesions (tumor cells in cerebrospinal fluid, and/or MRI shows intracranial lymphoma invasion);
- Extensive invasions of gastrointestinal lymphoma (lesions involving the muscular layer, serosa and subserosa, excluding lesions confined to the mucosa and submucosa);
- History of other primary cancer, except for the following conditions:
- Cured non-melanoma after resection, such as basal cell carcinoma of the skin
- Cured carcinoma in situ, such as cervical cancer, bladder cancer or breast cancer
- Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;
- Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;
- Women pregnant or lactating, with a pregnancy plan within 6 months, fertile but unable to take medically acceptable contraception measures;
- Patients who have participated in any other clinical studies within 2 weeks prior to screening;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Official title: A Phase I Clinical Trial of CTA101 UCART Cells Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of CTA101 in relapsed or refractory diffuse large B-cell lymphoma patients.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- CTA101
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTA101Biological
Universal CD19-directed CAR-T cells by a single infusion intravenously will be given in escalating doses. Subjects will been distributed into low dose (0.2×10^6), medium dose (2×10^6), and high dose (3×10^6).
| Study group | Role | What they receive |
|---|---|---|
| CTA101 | Experimental | Not described Receives: Biological: CTA101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity（DLT）
Adverse events assessed according to NCI-CTCAE v4.03 criteria
Measured: Baseline up to 35 days after T cell infusion
Secondary outcomes (2)
Overall response rate (ORR)
Assessment of overall response rate for weeks 4, 12, months 6, 12, 18 and 24 in accordance with Lugano 2014 (overall response rate，OR)
Measured: 4 weeks, 12 weeks, 6 months, 12 months, 18 months and 24 months
Disease control rate (DCR)
Assessment of overall response rate for weeks 12, months 6, 12, 18 and 24 in accordance with Lugano 2014（disease control rate，DCR)
Measured: 12 weeks, 6 months, 12 months, 18 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start1 Dec 2019 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026100
- Sponsor's protocol ID
- JSPH-CTA101
- Status last verified
- Oct 2019
- First submitted
- 17 Jul 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of CTA101 UCART Cells Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT04026100
- Acronym / sponsor ID
- JSPH-CTA101
- Conditions
- Diffuse Large B-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Jul 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 single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of CTA101 in relapsed or refractory diffuse large B-cell lymphoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTA101 | Experimental | Biological: CTA101 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed diagnosis of DLBCL per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL and PMBCL transformed from follicular lymphoma;
- Relapsed or refractory DLBCL (meeting one of the following conditions):
- At least one measurable lesion must be ≥ 1.5cm in the longest diameter;
- Male or female aged 18-70 years;
- Estimated survival time ≥ 12 weeks;
Key exclusion criteria (18 listed)
- History of hypersensitivity to any component of cell product;
- Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
- Recurrence after allogeneic hematopoietic stem cell transplantation;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis), or currently receiving antibiotic therapy by intravenous drip. However, prophylactic antibiotic, antiviral and antifungal treatments are allowed;
- HBV DNA copy number detected by PCR in patients with active hepatitis B is > 1000 at screening (if HBsAg positive, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection;
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 |
|---|---|---|
| CTA101Universal CD19-directed CAR-T cells by a single infusion intravenously will be given in escalating doses. Subjects will been distributed into low dose (0.2×10^6), medium dose (2×10^6), and high dose (3×10^6). | Biological | CTA101 |
Primary outcome
Dose-limiting toxicity（DLT）
Time frame: Baseline up to 35 days after T cell infusion
Adverse events assessed according to NCI-CTCAE v4.03 criteria
2 secondary outcomes
Overall response rate (ORR)
Time frame: 4 weeks, 12 weeks, 6 months, 12 months, 18 months and 24 months
Disease control rate (DCR)
Time frame: 12 weeks, 6 months, 12 months, 18 months and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTA101 in people with Diffuse Large B-cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 15 inclusion and 18 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 31 Oct 2019. 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 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.
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 Jianyong Li, Ph.D. (025-83718836, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity（DLT） (time frame: Baseline up to 35 days after T cell infusion). 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 31 Oct 2019.