Authorised Phase I and Phase II (Integrated)- First administration to humans Relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) or chronic lymphocytic leukaemia (CLL)

QUADvance: Advancing Allogeneic Quad-CAR01-T Therapy in Hard-to-Treat B-Cell Cancers

EU CTIS ID: 2025-521735-36-00

What this study is testing

Phase Ia: To assess the safety and tolerability of different dose levels of Allo-QuadCAR01-T Phase Ib: To assess the safety and tolerability of Allo-QuadCAR01-T and confirm the recommended Phase 2 dose (RP2D) of Allo-QuadCAR01-T Phase II: To evaluate the clinical efficacy of Allo-QuadCAR01-T

Phase I and Phase II (Integrated)- First administration to humans

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Male or female, ≥ 18 years old.
10. Life expectancy of ≥ 3 months as assessed by the Investigator.
11. Central venous access or willingness to have one.
12. Weight is greater than the minimum weight required for a specific batch to ensure that the dose administered does not exceed 10^5 TCR+ cells/kg of patient weight.
13. A woman of childbearing potential (WOCBP) may be enrolled if she has a negative serum pregnancy test at Screening visit and is willing to use a highly effective method of birth control (Pearl index of ≤ 1 required) resulting in a low failure rate (e.g., hormonal contraception, intrauterine device, total sexual abstinence, or sterilization) for at least 12 months after LD chemotherapy. Male patients must also practice a highly effective method of birth control and should not father a child or donate sperm for at least 6 months after end of LD chemotherapy.
2. Willing and able to give written informed consent.

You likely can't join if

1. Active CNS involvement (including PCNSL) is excluded from dose escalation cohorts. However, these individuals may be enrolled to established safe dose cohorts (i.e., backfill cohorts, dose expansion) with Sponsor approval.
7. History of graft versus host disease (GvHD) or post-transplant lymphoproliferative disorder.
8. Presence of autoantibodies against La/SS-B or presence or history of autoimmune diseases associated with such antibodies.
9. History of other malignancy that could affect compliance with the protocol or interpretation of results, excluding: • History of curatively treated basal or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix at any time prior to Screening. • Low-grade, early-stage prostate cancer (Gleason score ≤ 6, Stage 1 or 2) with no requirement for therapy at any time prior to Screening. • Current adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer for 2 or more years prior to Screening. • Any other malignancy treated with curative intent and in remission without treatment for 2 years prior to Screening.
13. Active or residual HBV, HCV, or syphilis.
14. Active HIV disease. Individuals with positive HIV history may be included with Sponsor approval after Phase Ia dose escalation if: • Ongoing antiretroviral treatment for ≥ 6 months • Adherence to antiretroviral treatment per Investigator judgement and leading to good treatment response • Good treatment response, defined by absence of clinical symptoms (including infectious and constitutional), normal blood CD4+ count (at least 500 cells /μL), and undetected HIV RNA (≤ 50 copies /mL).

See the full eligibility criteria

Who can join

1. Male or female, ≥ 18 years old.
10. Life expectancy of ≥ 3 months as assessed by the Investigator.
11. Central venous access or willingness to have one.
12. Weight is greater than the minimum weight required for a specific batch to ensure that the dose administered does not exceed 10^5 TCR+ cells/kg of patient weight.
13. A woman of childbearing potential (WOCBP) may be enrolled if she has a negative serum pregnancy test at Screening visit and is willing to use a highly effective method of birth control (Pearl index of ≤ 1 required) resulting in a low failure rate (e.g., hormonal contraception, intrauterine device, total sexual abstinence, or sterilization) for at least 12 months after LD chemotherapy. Male patients must also practice a highly effective method of birth control and should not father a child or donate sperm for at least 6 months after end of LD chemotherapy.
2. Willing and able to give written informed consent.
3. Have histologically confirmed R/R B-NHL or CLL, per WHO classification, expected to express CD19 and/or CD20, have received, deemed ineligible for, or have declined standard therapies reimbursed by their health care system, have received a minimum of 2 treatment lines, and have a clinical need for systemic treatment. • Large B-cell lymphoma (LBCL) (including e.g., diffuse large B-cell lymphoma (DLBCL), High-grade BCL (HGBL), transformed LBCL from indolent lymphoma or CLL, Primary mediastinal large B-cell lymphoma (PMBCL) – but not primary CNS lymphoma (PCNSL)) • Follicular lymphoma (FL) • Marginal zone lymphoma (MZL) • Mantle cell lymphoma (MCL) • Chronic lymphocytic leukemia/Small lymphocytic leukemia (CLL/SLL)
4. For lymphomas (including SLL), measurable disease with at least 1 bi-dimensional measurable lesion (CT/MRI), longest diameter > 1.5 cm for nodal, > 1 cm for extra-nodal within a month of the treatment start, and after any anti-lymphoma therapies. Previously radiated lesions are eligible only if there is documented progression on the site after radiation therapy. Only MRD positivity is not considered eligible.
5. For CLL, indication for treatment per iwCLL 2018 guideline and objectively measurable disease (e.g., lymphocytosis or measurable lesion, including lymphadenopathy, splenomegaly, and extra-nodal lesions, but not e.g., autoimmune manifestations only, or MRD positivity).
6. Fresh or archival biopsy sample available (obtained after last systemic treatment line), or willingness to provide one for retrospective CD19/CD20 expression analysis. A patient may be included without biopsy material with Sponsor approval if the biopsy procedure would cause unacceptable safety risk or discomfort.
7. HLA B and C types match 1 or more of the available IMP batches.
8. ECOG 0 to 1.
9. Adequate organ function: • Calculated CrCl ≥ 60 mL/min Note: CrCl must be calculated using the Cockcroft-Gault Method: CrCl = ((140 – age) × weight)/(72 × SCr)) [× 0.85 (if female)] CrCl = mL/minute; Age = years; Weight = kg; SCr = mg/dL • Direct bilirubin ≤ 1.5 × ULN (unless Gilbert’s syndrome) • AST/ALT ≤ 2.5 × ULN (up to 5 × ULN if elevation directly caused by lymphoma infiltration) • LVEF ≥ 45% (per local standard method, e.g., transthoracic echocardiography) • Oxygen saturation ≥ 92% on room air • Blood counts: - ANC ≥ 1.0 × 10^9 L (≥ 0.75 × 10^9 /L may be eligible with Sponsor approval) - Platelets ≥ 50 × 10^9 /L - Hb ≥ 7 g/dL Note: Lower levels may be allowed after Sponsor approval if cytopenia directly caused by lymphoma/CLL infiltration.

What rules you out

1. Active CNS involvement (including PCNSL) is excluded from dose escalation cohorts. However, these individuals may be enrolled to established safe dose cohorts (i.e., backfill cohorts, dose expansion) with Sponsor approval.
7. History of graft versus host disease (GvHD) or post-transplant lymphoproliferative disorder.
8. Presence of autoantibodies against La/SS-B or presence or history of autoimmune diseases associated with such antibodies.
9. History of other malignancy that could affect compliance with the protocol or interpretation of results, excluding: • History of curatively treated basal or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix at any time prior to Screening. • Low-grade, early-stage prostate cancer (Gleason score ≤ 6, Stage 1 or 2) with no requirement for therapy at any time prior to Screening. • Current adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer for 2 or more years prior to Screening. • Any other malignancy treated with curative intent and in remission without treatment for 2 years prior to Screening.
13. Active or residual HBV, HCV, or syphilis.
14. Active HIV disease. Individuals with positive HIV history may be included with Sponsor approval after Phase Ia dose escalation if: • Ongoing antiretroviral treatment for ≥ 6 months • Adherence to antiretroviral treatment per Investigator judgement and leading to good treatment response • Good treatment response, defined by absence of clinical symptoms (including infectious and constitutional), normal blood CD4+ count (at least 500 cells /μL), and undetected HIV RNA (≤ 50 copies /mL).
15. Active or recent (within 6 months of Screening) cerebrovascular ischemia/hemorrhage, dementia, Parkinson’s disease, cerebellar disease, or autoimmune disease with CNS involvement that may impair ability to evaluate neurotoxicity or have an impact on trial safety per Sponsor or Investigator assessment.
16. History of MI, cardiac angioplasty or stenting, unstable angina or other clinically significant cardiac disease within 6 months of Screening with an impact on trial safety per Sponsor or Investigator assessment.
17. Primary immunodeficiency or history of autoimmune disease (e.g., Crohn’s disease, rheumatoid arthritis, systemic lupus) requiring systemic treatment within 1 year of Screening unless stable and not increasing safety risk per Investigator judgement and approved by the Sponsor.
18. Other non-hematological toxicity from prior anti-cancer treatment that has not resolved to Grade ≤1 or baseline, except for peripheral neuropathy which is eligible up to Grade 2.
19. Systemic immunosuppression within 28 days of Screening.
10. Active viral infection within 1 week of Screening or ongoing bacterial or fungal infection requiring hospitalization or intravenous antimicrobials, or any other ongoing infection that would have a significant impact on safety or trial conduct per Investigator or Sponsor judgement.
20. Last systemic lymphoma or CLL treatment, including standard and investigational treatments, within 28 days or within 5 half-lives of Screening, whichever is shorter.
21. Major surgery within 14 days of Screening.
22. Local radiation within 28 days of Screening.
23. Live vaccination within 28 days of Screening.
24. Pregnant or breastfeeding. Note: Any period mentioned before Screening (i.e., within xx days/week “of Screening”) means time before the last day of Screening period (eligibility confirmation date by the Sponsor or delegate).
11. Presence of hemorrhagic cystitis.
12. Active neuro-autoimmune diseases, including MS, Guillain-Barré, ALS.
2. Prior CAR-T treatment within 3 months of Screening, or ≥ Grade 3 ICAHT associated with prior CAR-T treatment. Note: ICAHT per EHA/EBMT recommendation, Grade 3: ANC ≤ 0.1 × 10^9 /L for 7 days, or ANC ≤ 0.5 × 10^9 /L for 14 days, or ANC ≤ 0.5 × 10^9 /L 30 days after the CAR-T administration or later.
3. Hematological autologous hematopoietic stem cell transplantation within 3 months.
4. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplant.
5. Prior therapy with dual CD19/CD20 targeting CAR-T.
6. Known severe hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in trial.

The study team makes the final eligibility decision.

Where it's taking place

United States
United Kingdom

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.