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New treatment option for Lymphoid
Official title Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies
ClinicalTrials.gov ID: NCT07444632
What this study is testing
What is Fludarabine?
Fludarabine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoid.
Also referred to as Fludara.
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 phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 18-75 years of age.
- Diagnosis of relapsed B-NHL, HL, T-NHL, or B-ALL in refractory relapse, defined as:
- B-NHL: Failure of \>/= 1 salvage line and failure of or ineligibility for CAR-T.
- HL and T-NHL: Failure of \>/= 1 salvage line or prior SCT.
- ALL: Active disease (\>5% of blasts or positive MRD at a level of \>0.1% measured by multiparameter flow cytometry) after ≥ 2 two lines of therapy...
You likely can't join if
- Lymphoma or ALL in CR with no measurable sites of disease.
- Major surgery \<4 weeks prior to first dose of study drug.
- Any other severe or uncontrolled disease or condition which mightincrease the risk associated with study participation.
- Any other malignancy known to be active, with the exception of treated cervical intraepithelial neoplasia and non-melanoma skincancer.
- Grade \>/= 3 non-hematologic toxicity from prior therapy that has notimproved to grade \</= 2.
- Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \>/=10,000 copies/mL, or \>/=2,000 IU/mL), or hepatitis C (detectable viral...
See the full eligibility criteria
Who can join
- 18-75 years of age.
- Diagnosis of relapsed B-NHL, HL, T-NHL, or B-ALL in refractory relapse, defined as:
- B-NHL: Failure of \>/= 1 salvage line and failure of or ineligibility for CAR-T.
- HL and T-NHL: Failure of \>/= 1 salvage line or prior SCT.
- ALL: Active disease (\>5% of blasts or positive MRD at a level of \>0.1% measured by multiparameter flow cytometry) after ≥ 2 two lines of therapy. Patients with B-ALL must have either failed of or be ineligible for...
- Expression of CD70 in the pre-enrollment sample \>/= 20% measured by immunohistochemistry or flow cytometry.
- Measurable disease, defined by \>/= 1 histologically confirmed hypermetabolic lesion on PET/CT scan.
- ECOG PS ≤ 2 (Karnofsky ≥60%).
- Adequate blood counts (WBC \>/= 2K, HGB \>/= 8 g/dL, platelets \>/= 50K).
- Creatinine clearance ≥ 30 ml/min.
- ALT and/or AST ≤ 3 x ULN, and bilirubin and ALP ≤ 2 x ULN.
- FEV1, FVC and DLCOc ≥ 50%.
- LVEF ≥ 40%, without active arrythmias.
- If female of child-bearing potential, she must not be pregnant or breastfeeding and required to have a negative urine or serum pregnancy test prior to enrollment.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection still on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or how well it works assessment of the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- The effects of CAR-NK cells on the developing human fetus are unknown. For this reason and because fludarabine and cyclophosphamide, as well as other therapeutic agents, used in this trial are known to be teratogenic...
- This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received whole pelvic radiation therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control (see Appendix 1) are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal ligation or...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of CAR NK cell administration.
- Ability to understand and willingness to sign a written informed document.
- Agree to sign consent to the long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.
What rules you out
- Lymphoma or ALL in CR with no measurable sites of disease.
- Major surgery \<4 weeks prior to first dose of study drug.
- Any other severe or uncontrolled disease or condition which mightincrease the risk associated with study participation.
- Any other malignancy known to be active, with the exception of treated cervical intraepithelial neoplasia and non-melanoma skincancer.
- Grade \>/= 3 non-hematologic toxicity from prior therapy that has notimproved to grade \</= 2.
- Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \>/=10,000 copies/mL, or \>/=2,000 IU/mL), or hepatitis C (detectable viral load by HCV RNA PCR).
- Active infection requiring parenteral antibiotics.
- HIV infection.
- Treatment within prior 2 weeks with any anti-cancer agent,investigational or approved.
- Active CNS involvement (untreatedparenchymal brain metastasis or positive cytology of cerebrospinal fluid).
- Life expectancy \</= 6 months.
- Active and uncontrolled neurological disorder.
- Patients receiving systemic steroid therapy at time of enrollment (physiological replacement doses are allowed) or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or...
- Patients receiving immunosuppressive therapy.
- Patients who are receiving any other investigational agents.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.