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New treatment option for Follicular Lymphoma
Official title AutologousCD22 Chimeric Antigen Receptor (CAR)T Cells in w/Recurrent/Refractory B Cell Lymphomas
ClinicalTrials.gov ID: NCT06340737
What this study is testing
What is CD22CART Infusion?
CD22CART Infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for follicular lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a non-randomized clinical trial to evaluate the safety and efficacy of CD22CART administered after lymphodepleting chemotherapy in adults with relapsed / refractory B Cell Lymphomas. All evaluable participants will be followed for overall survival (OS), progression free survival (PFS), and duration of response (DOR).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Disease: Must have histologically confirmed disease as defined by WHO 2016[117] of one of the following: Follicular Lymphoma, grade 1-3a
- Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined...
- Relapsed or progressive disease within 24 months of initiation of the initial course of chemotherapy (also known as progression of disease within 24...
- Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \<11 g/dL), thrombocytopenia (platelets\<100 x 10\^9 /L)...
- Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog. Lymphoplasmacytic lymphoma (Waldenstrom...
You likely can't join if
- Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.
- 2\. History or current other malignancies, apart from non-melanoma skin cancer, low-grade untreated prostate cancer under observation, or carcinoma...
- 3\. Presence of active fungal, bacterial, viral or other infection requiring intravenous antimicrobials. Simple UTI or uncomplicated bacterial...
- 4\. Ongoing HIV, HBV, or HCV infection. History of HBV or HCV is permitted if viral load is undetectable by qPCR and/or nucleic acid testing.
- 5\. Active cerebrovascular ischemic/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in investigator's...
- 6\. History of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.
See the full eligibility criteria
Who can join
- Disease: Must have histologically confirmed disease as defined by WHO 2016[117] of one of the following: Follicular Lymphoma, grade 1-3a
- Relapsed or refractory disease after at least 2 lines of systemic therapy. Prior therapy must have included an anti-CD20 monoclonal antibody combined with systemic therapy (single-agent anti- CD20 antibody does not...
- Relapsed or progressive disease within 24 months of initiation of the initial course of chemotherapy (also known as progression of disease within 24 months POD24). Initial treatment must have included an anti-CD20...
- Diagnosis of HCL and require treatment as defined by having HCL-related anemia (hemoglobin \<11 g/dL), thrombocytopenia (platelets\<100 x 10\^9 /L), or neutropenia (absolute neutrophil count below 1.5 x 10\^9/L)...
- Must have progressed or been refractory to 2 lines of therapy including a purine nucleoside analog. Lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia (WM)) - participants must meet all eligibility criteria...
- people with DLBCL, Follicular Lymphoma Grade 3B -or- people with transformed FL and MZL who HAVE NOT received chemotherapy prior to transformation: 1) Must have received an anthracycline regimen and an anti CD20...
- people with transformed FL and MZL who HAVE received anthracycline-containing chemotherapy prior to transformation must have progressed, had SD or recurred with transformed disease after initial treatment for LBCL:
- Must have progressed, had SD, or recurred with transformed disease after initial treatment for LBCL Note: T cell/histiocyte rich large B cell lymphoma is not eligible The following criteria apply to all participants...
- a. Participants with Follicular Lymphoma, Mantle Cell Lymphoma, Burkitt Lymphoma and Marginal Zone Lymphoma must have measurable disease according to the revised IWG Response Criteria for Malignant Lymphoma. Lesions...
- c. Participants with Hairy Cell Lymphoma must have presence of leukemic cells in the bone marrow or blood stream.
- d. Participants with Lymphoplasmacytic lymphoma must have the presence of serum IgM that is at least 2 times the upper limit of normal. 3\. CD22 expression, at any level: Participants must have archival tissue available...
- Platelet count ≥ 50,000/uL
- ALC ≥ 150/uL
- Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine \< 2 mg/dL OR Creatinine clearance (as estimated by Cockcroft Gault Equation) ≥ 45 mL/min, Serum ALT or AST ≤ 10 x ULN (except in...
- No clinically significant pleural effusion or ascites
- Baseline oxygen saturation \> 92% on room air ANC Platelet ALC Cr CreatCl AST/ALT Bilirubin LVEF O2 Sat
- 11\. Participants with CNS involvement or a history of CNS involvement are eligible only in the absence of neurologic symptoms that may mask or interfere with neurological assessment of toxicity 12. Females of...
What rules you out
- Presence rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy.
- 2\. History or current other malignancies, apart from non-melanoma skin cancer, low-grade untreated prostate cancer under observation, or carcinoma in situ, unless disease free for at least 3 years, or in remission 1-2...
- 3\. Presence of active fungal, bacterial, viral or other infection requiring intravenous antimicrobials. Simple UTI or uncomplicated bacterial pharyngitis is permitted if responding to active treatment.
- 4\. Ongoing HIV, HBV, or HCV infection. History of HBV or HCV is permitted if viral load is undetectable by qPCR and/or nucleic acid testing.
- 5\. Active cerebrovascular ischemic/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement that in investigator's judgement impair ability to evaluate neurotoxicity.
- 6\. History of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 12 months of enrollment.
- 7\. Severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study.
- 8\. Is pregnant or breastfeeding.
- 9\. Active primary immunodeficiency or history of autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus) requiring systemic immunosuppression/systemic disease modifying agents within the last 2...
- 10\. May NOT, in investigator's judgment, have any medical condition likely to interfere with assessment of safety or how well it works, or be likely to complete all protocol-required visits and procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.