Adaptive dual-target CAR-T therapy for relapsed or refractory blood cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/2 master protocol uses central immunophenotyping to match adults with relapsed or refractory hematologic malignancies to a biomarker-selected dual-target CAR-T module (for example CD19/CD22, CD19/CD20, BCMA/CD38, CD33/CD123, or CD5/CD7). Participants undergo leukapheresis, optional bridging therapy, fludarabine/cyclophosphamide lymphodepletion, and infusion of the selected autologous dual-target CAR-T product delivered as a tandem, bicistronic, compound, or sequential infusion depending on the antigen pair. Phase 1 identifies safety, dose-limiting toxicities, and the recommended phase 2 dose for each module, while phase 2 estimates preliminary antitumor activity including overall response rate and MRD-negative responses. Intensive monitoring through the first 28 days and scheduled longer-term follow-up will capture adverse events, response durability, and signs of antigen escape.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 75 years at the time of consent.
* Pathologically or cytologically confirmed eligible disease: B-ALL; B-cell NHL/CLL/SLL; multiple myeloma/plasma cell leukemia; AML/high-risk MDS/BPDCN; or T-ALL/T-LBL/peripheral T-cell lymphoma.
* Relapsed or refractory disease after at least 2 prior lines of therapy, or no curative/approved standard option judged appropriate by the investigator.
* Central laboratory confirmation that at least one active dual-target module is suitable based on malignant-cell antigen co-expression and safety review.
* Measurable or otherwise evaluable disease by disease-specific response criteria.
* ECOG performance status 0 to 2.
* Adequate organ function: LVEF \>= 45%; creatinine clearance \>= 40 mL/min; AST/ALT \<= 3 x ULN; total bilirubin \<= 1.5 x ULN unless due to Gilbert syndrome; oxygen saturation \>= 92% on room air.
* Adequate hematologic reserve unless cytopenia is clearly disease-related.
* Ability to undergo leukapheresis and willingness to comply with study procedures and follow-up.
* If prior allogeneic HSCT: at least 100 days from transplant, no uncontrolled GVHD, and no systemic immunosuppression above physiologic steroid replacement.
* Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception during protocol-defined risk periods.
* Written informed consent obtained before any study-specific procedure.

Exclusion Criteria:

* \- Active uncontrolled infection, including uncontrolled bacterial, fungal, or viral infection, or clinical sepsis.
* Active symptomatic CNS involvement requiring escalating therapy; previously treated/stable CNS disease may be allowed if defined prospectively in the final protocol.
* Prior gene-modified cellular therapy within 12 weeks before leukapheresis, or unresolved \>= Grade 3 toxicity from prior anticancer therapy
* Need for urgent cytoreduction such that manufacturing delay would create unacceptable clinical risk.
* Active autoimmune disease requiring systemic immunosuppression, except limited replacement-dose steroids or protocol-permitted topical/inhaled therapy.
* Prior solid organ transplant.
* Clinically significant cardiovascular disease, uncontrolled arrhythmia, decompensated heart failure, myocardial infarction within 6 months, or recent stroke within 6 months.
* Uncontrolled HIV, HBV, or HCV viremia.
* Pregnancy or breastfeeding.
* Another active malignancy requiring systemic therapy, unless low-risk and definitively treated per protocol-defined exceptions.
* Known hypersensitivity to fludarabine, cyclophosphamide, or critical product excipients.
* Inability to manufacture a releaseable CAR-T product or failure to meet module-specific product-release criteria.
* Any medical, psychiatric, or social condition that, in the investigator's judgment, would increase risk, impair compliance, or confound interpretation of study results.

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: shan S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL

  This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07927816

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

  This study is testing a new CAR T-cell therapy for people with T-cell lymphomas that haven't responded to regular treatments to see if it is safe and effective.

  Recruiting at 4 sites Phase 1/2 Beijing GoBroad Hospital · Beijing, Beijing Municipality and 3 other locations · NCT06925464

• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

  This study is testing if a combination of golcadomide and rituximab can help patients with aggressive B-cell lymphoma get ready for CAR T-cell therapy.

  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.