DuoCAR20.19.22-D95 for Relapsed/Refractory B-cell Malignancies
This study is testing a new cell therapy called DuoCAR20.19.22-D95 for adults with B-cell Non-Hodgkin Lymphoma (NHL) or B-cell Acute Lymphoblastic Leukemia (ALL) that has come back or not responded to previous treatments. DuoCAR20.19.22-D95 uses your own immune cells (T cells) that are specially modified to find and fight cancer cells. Before receiving DuoCAR20.19.22-D95, you will receive chemotherapy (Fludarabine and Cyclophosphamide) to prepare your body. The main goals are to find the safest dose of DuoCAR20.19.22-D95 and to see how safe it is overall. This study is currently recruiting 54 participants, but the exact recruitment status is unclear.
- Study design
- This is a Phase 1 study with a "3 + 3" dose escalation design, meaning different groups of participants will receive increasing doses of the treatment. It plans to enroll 54 participants.
- What's involved
- Participants will have assessments for side effects for about 30 days after receiving the DuoCAR20.19.22-D95 cells. Routine safety and effectiveness monitoring will continue for up to 2 years, or until a new treatment is started.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 15 years after receiving the DuoCAR20.19.22-D95 cell infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06879340
Evaluating the Safety and Efficacy of DuoCAR20.19.22-D95 in Adult Patients With Relapsed or Refractory B-cell Malignancies
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Kansas Medical CenterInvestigator-initiated
~54 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:DuoCAR20.19.22-D95Fludarabine (Conditional therapy)Cyclophosphamide (Conditional therapy)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose (MTD)
Measured over Approximately 30 days
+4 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesKansas1
Study leadership
- Joseph McGuirk, D.O. · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients with relapsed or refractory disease after allogeneic stem cell transplantation must be \>100 days from HSCT to be eligible for study participation. Furthermore, post-HSCT immunosuppressive medications must be discontinued for at least 4 weeks prior to study entry
Prior CAR-T therapy is permissible if ≥ 3 months from therapy completion
Morphological disease in the bone marrow Note: Morphologic disease is defined as blasts being at least 5% in the bone marrow.
Refractory disease is defined as progressive or stable disease as the best response to the most recent prior therapy or relapse within 12 months of autologous stem cell transplantation. Two prior lines of therapy are required for LBCL eligibility. The second line therapy may be chemotherapy based, autologous stem cell transplantation, or CAR-T.
Relapsed or refractory disease after allogeneic transplant provided patient is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment
Patients must have received 2 or more lines of adequate prior therapy including at a minimum:
anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20- negative and
an anthracycline containing chemotherapy regimen
for patients with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL vi. Prior CAR T therapy permissible if ≥ 3 months from the therapy vii. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy C. Relapsed or refractory indolent non-Hodgkin lymphoma i. Histologically confirmed indolent non-Hodgkin lymphoma, including grade 1-3b follicular lymphoma or nodal or extranodal marginal zone lymphoma (both per WHO 2016 classification criteria) ii. Relapsed or refractory disease (per Lugano criteria) after two or more previous lines of therapy, iii. Previous lines of therapy to include an anti-CD20 monoclonal antibody combined with an alkylating agent iv. Prior CAR T therapy permissible if ≥ 3 months from the therapy v. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy vi. Relapsed or refractory disease after allogeneic transplant provided patient is at least 100 days from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment D. Relapsed or Refractory Mantle-Cell Lymphoma i. Histologically confirmed mantle-cell lymphoma with either cyclin D1 overexpression or presence of the translocation (T11:14) ii. Disease that is either relapsed or refractory to at least 2 prior lines of previous regimens for mantle-cell lymphoma iii. Previous therapy must have included anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 monoclonal antibody, and BTK inhibitor therapy 4. Prior CAR T therapy permissible if ≥ 3 months from the therapy 5. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Cheson 2007). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy 6. Relapsed or refractory disease after allogeneic transplant provided patient is ≥ 3 months from stem cell transplant at the time of enrollment and off of immunosuppressive medications for at least 4 weeks prior to enrollment 7. Meet institutional criteria for leukapheresis procedure or have availability of previously- collected and stored leukapheresis product that satisfies minimum requirements 8. Eastern cooperative oncology group (ECOG) performance status of 0 to 2. 9. Adequate hematologic and organ function NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient. 10. Adults ≥ 18 years of age, with no upper limit of age 11. Life expectancy \>2 months 12. ≥ 3 months from prior CAR 13. Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section from the time of signing informed consent to at least 12 months following DuoCAR20.19.22-D95 infusion and until CAR positive viable T cells are no longer present by quantitative polymerase chain reaction (qPCR) on two consecutive tests. Men must agree not to donate sperm for the same time period.
What this trial measures
- Maximum Tolerated Dose (MTD)Approximately 30 days
The MTD is defined as the dose level immediately below that in which ≥ 2/6 participants experience a dose limiting toxicity (DLT).
- Recommended Phase 2 Dose (RP2D)Approximately 30 days
Determine using MTD and DLTs.
- Safety: Incidence of Serious Adverse Events/Adverse EventsApproximately 30 days
Toxicities of DuoCAR20.19.22-D95 in combination with preceding lymphodepleting chemotherapy regimen As measured with CTCAE v 5.0,
- Treatment-related Mortality (TRM)Approximately 1 year
defined by the absence of progressive disease at the time of death.
- Presence of replication competent lentivirus (RCL) in peripheral blood samplesApproximately 15 years
Measured with qPCR