Anaplastic Large Cell LymphomaPhase 1CERTAINNCT04526834
Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
A Phase 1 study testing CD30.CAR-T in people with Anaplastic Large Cell Lymphoma and Peripheral T Cell Lymphoma, run by Tessa Therapeutics at 4 sites in United States.
Trial summary
This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anaplastic Large Cell Lymphoma, Peripheral T Cell Lymphoma, Extranodal NK/T-cell Lymphoma
- What is being tested?
- CD30.CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Sep 2021to Mar 2036
- Phase
- Phase 1
- 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
- Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:
- Signed Informed Consent Form
- Male or female patients who are 18-75 years of age
- Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
- Relapsed or refractory CD30-positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT CD30-positive tumor
- At least 1 measurable lesion according to the Lugano Classification
- ECOG PS of 0 to 1 or equivalent Karnofsky PS Anticipated life expectancy >12 weeks
Who cannot join
- CNS involvement by malignancy
- Inadequate laboratory abnormalities at screening:
- Hgb ≤ 8.0 g/dL Total bilirubin > 1.5 x ULN (>2 x ULN for patients with Gilbert's syndrome) AST and ALT ≥ 5 x ULN CrCL ≤ 45 mL/min (as measured by Cockcroft-Gault equation) ANC ≤ 1000/uL Platelets ≤75,000/uL PR or INR >1.5 x ULN aPTT> 1.5 x ULN
- Active uncontrolled bleeding or a known bleeding diathesis
- Inadequate pulmonary function defined as pulse oximetry < 90% on room air
- Ongoing treatment with immunosuppressive drugs including calcineurin inhibitions, TNFalpha, mTOR, etc or chronic systemic corticosteroids (>10 mg/day prednisone or equivalent for >48 hours)
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- Received prior therapy of:
- Anti-CD30 Ab based therapy within the previous 8 weeks Previous CD30.CAR-T investigational product Bi-specific CD30 Ab within the previous 8 weeks Allogenic HSCT in the last 180 days Autologous HSCT within 90 days
- Active GVHD requiring immune suppression regardless of grade
- HIV positive
- Active HBV and/or HCV
Trial locations and contacts
4 sites in 1 country.
United States4 sites
City of Hope
Duarte, California, 91010
Baylor College of Medicine
Houston, Texas, 77030
The University of Texas MD Anderson Cancer Centre
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
About this study
Official title: Phase 1 Study of CD30-Directed Genetically Modified Autologous T-Cells (CD30.CAR-T) in Patients With Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
This is a phase 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma
Read the detailed description
Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells.
CD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine.
Subjects will be closely monitored for DLT and safety.
- Conditions
- Anaplastic Large Cell Lymphoma, Peripheral T Cell Lymphoma, Extranodal NK/T-cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- Being tested
- CD30.CAR-T
- Keywords
- CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult
- Medical subject headings
- Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Peripheral, Lymphoma, Extranodal NK-T-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD30.CAR-TDrug
Also called CD30-directed genetically modified autologous T cells
Bendamustine and Fludarabine (3 days)
Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0)
Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0)
Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)
| Study group | Role | What they receive |
|---|---|---|
| CD30 positive NHL subtypes | Experimental | (ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL)
Dose Level 1
Dose Level 2
Dose Level 3 Receives: Drug: CD30.CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose
Incidence of DLTs and occurrence of study related adverse events
Measured: Day 0 to 28 for DLT
Secondary outcomes (4)
To evaluate pharmacokinetics of autologous CD30.CAR-T
AUC (copies/ug DNA over time)
Measured: Start of infusion of CD30.CAR-T (Day 0) until year 5
Objective Response Rate (ORR)
ORR
Measured: Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year
Duration of Response (DOR)
DOR
Measured: Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year
Progression Free Survival (PFS)
PFS
Measured: Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start8 Sep 2021
- Primary completion22 Nov 2022
- Study completionMar 2036 (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 Anaplastic Large 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tessa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sairah Ahmed, Principal investigator, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526834
- Sponsor's protocol ID
- TESSCAR002
- Acronym
- CERTAIN
- Status last verified
- Apr 2023
- First submitted
- 20 Aug 2020
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
PubMed 34515338
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of CD30-Directed Genetically Modified Autologous T-Cells (CD30.CAR-T) in Patients With Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT04526834
- Acronym / sponsor ID
- CERTAIN / TESSCAR002
- Conditions
- Anaplastic Large Cell Lymphoma, Peripheral T Cell Lymphoma, Extranodal NK/T-cell Lymphoma, Diffuse Large B Cell Lymphoma, Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- Keywords
- CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Tessa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- Mar 2036 (estimated)
- First posted
- 26 Aug 2020 (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 1 study to evaluate safety and dose-limiting toxicity of autologous CD30.CAR-T in subjects with relapsed or refractory CD30+ Non-Hodgkin Lymphoma
Detailed description
Adult patients with relapsed or refractory CD30-positive Non-Hodgkin Lymphoma who have failed standard available therapies and who meet eligibility criteria will have blood drawn to manufacture the CD30.CAR-T cells.
CD30.CAR-T cells will be infused once following the completion of lymphodepleting chemotherapy with Bendamustine and Fludarabine.
Subjects will be closely monitored for DLT and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD30 positive NHL subtypes | Experimental | Drug: CD30.CAR-T(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL) Dose Level 1 Dose Level 2 Dose Level 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligibility is determined priori to leukapheresis. Patients must satisfy the following criteria to be enrolled in this study:
- Signed Informed Consent Form
- Male or female patients who are 18-75 years of age
- Histologically confirmed ALCL, PTCL- NOS, ENKTCL nasal type, DLBCL-NOS and PMBCL
- Relapsed or refractory CD30-positive NHL who have failed all available standards of therapy. Patients may or may not have received an autologous or allogeneic HSCT CD30-positive tumor
Key exclusion criteria (11 listed)
- CNS involvement by malignancy
- Inadequate laboratory abnormalities at screening:
- Hgb ≤ 8.0 g/dL Total bilirubin > 1.5 x ULN (>2 x ULN for patients with Gilbert's syndrome) AST and ALT ≥ 5 x ULN CrCL ≤ 45 mL/min (as measured by Cockcroft-Gault equation) ANC ≤ 1000/uL Platelets ≤75,000/uL PR or INR >1.5 x ULN aPTT> 1.5 x ULN
- Active uncontrolled bleeding or a known bleeding diathesis
- Inadequate pulmonary function defined as pulse oximetry < 90% on room air
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 |
|---|---|---|
| CD30.CAR-TAlso: CD30-directed genetically modified autologous T cellsBendamustine and Fludarabine (3 days) Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0) Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0) Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0) | Drug | CD30 positive NHL subtypes |
Primary outcome
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose
Time frame: Day 0 to 28 for DLT
Incidence of DLTs and occurrence of study related adverse events
4 secondary outcomes
To evaluate pharmacokinetics of autologous CD30.CAR-T
Time frame: Start of infusion of CD30.CAR-T (Day 0) until year 5
Objective Response Rate (ORR)
Time frame: Start of CD30.CAR-T (Day 0) until progressive disease or start of new cancer therapy, whichever comes first, up to one year
Duration of Response (DOR)
Time frame: Start of CD30.CAR-T (day 0) until progressive disease or death, whichever comes first, up to one year
Progression Free Survival (PFS)
Time frame: Start of CD30.CAR-T (Day 0) until progressive disease or death, whichever comes first, up to one year
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 20 Apr 2023.
- Derived from this study: PubMed 34515338Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
- 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.
Sairah Ahmed principal investigator
MD Anderson
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD30.CAR-T in people with Anaplastic Large Cell Lymphoma and Peripheral T Cell Lymphoma, run by Tessa Therapeutics at 4 sites in United States.
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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 20 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 4 sites in United States. 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?
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?
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?
To evaluate safety and dose limiting toxicities (DLT) of autologous CD30.CAR-T and establish the recommended Phase dose (time frame: Day 0 to 28 for DLT). 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 NCT04526834, 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 20 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.