Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma (CERTAIN)
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ClinicalTrials.gov Identifier: NCT04526834 |
Recruitment Status :
Recruiting
First Posted : August 26, 2020
Last Update Posted : February 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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) | Drug: CD30.CAR-T | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 21 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | November 20, 2020 |
Estimated Primary Completion Date : | February 2022 |
Estimated Study Completion Date : | February 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: CD30 positive NHL subtypes
(ALCL, PTCL-NOS, ENKTCL, DLBCL-NOS, PMBCL) Dose Level 1 Dose Level 2 Dose Level 3 |
Drug: CD30.CAR-T
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) Other Name: CD30-directed genetically modified autologous T cells |
- 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
- To evaluate pharmacokinetics of autologous CD30.CAR-T [ Time Frame: Start of infusion of CD30.CAR-T (Day 0) until year 5 ]AUC (copies/ug DNA over time)
- 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 ]ORR
- 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 ]DOR
- 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 ]PFS

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
- 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)
-
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526834
Contact: Tessa Therapeutics | +65 62352129 | clinicaltrials@tessacell.com |
United States, California | |
City of Hope | Recruiting |
Duarte, California, United States, 91010 | |
Contact: Matthew Mei, MD | |
United States, Tennessee | |
Sarah Cannon Research Institute | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Ian Flinn, MD, PhD | |
United States, Texas | |
Baylor College of Medicine | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: Carlos Ramos, MD | |
The University of Texas MD Anderson Cancer Centre | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: Sairah Ahmed, MD 713-794-4374 sahmed3@mdanderson.org |
Principal Investigator: | Sairah Ahmed | MD Anderson |
Responsible Party: | Tessa Therapeutics |
ClinicalTrials.gov Identifier: | NCT04526834 |
Other Study ID Numbers: |
TESSCAR002 |
First Posted: | August 26, 2020 Key Record Dates |
Last Update Posted: | February 12, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CD30, r/r NHL, DLBCL, ALCL, ENKTCL, PMBCL, PTCL, adult |
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, T-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Anaplastic Lymphoma, T-Cell, Peripheral |
Lymphoma, Extranodal NK-T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |