Clinical trial · Interventional
Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Phase I Trial Of Intravenous Bispecific Antibody (4G7XH22) In Patients With Refractory Or Relapsed Non-Hodgkin's Lymphoma Or Chronic Lymphocytic Leukemia (CLL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Medarex (supplier of BsAb) stopped study due to toxicities experienced at other sites on unrelated trials halting manufacturing of BsAb
Summary
Brief summary (as posted)
RATIONALE: Antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of antibody therapy in treating patients who have refractory or relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bispecific antibody 4G7xH22 | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm
- description
- Antibody
- interventionNames
- Biological: bispecific antibody 4G7xH22
- Biological: sargramostim
Primary outcomes (2)
- measure
- Clinical Toxicity
- timeFrame
- day 1-29
- description
- This study was prematurely ended by the sponsor Medarex (supplier of BsAb) due to toxicities experienced at other sites on unrelated trials leading to the decision that Medarex would not be manufacturing the investigational product (BsAb).
- measure
- Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of BsAb 4G7 x 22
- timeFrame
- Day 1-29
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of CD19+ non-Hodgkin's lymphoma or chronic lymphocytic leukemia * Primary refractory or multiply relapsed (after at least 2 prior chemotherapy regimens) disease * Ineligible for bone marrow or peripheral blood stem cell transplantation PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Absolute neutrophil count greater than 1,500/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * Alkaline phosphatase less than 2 times normal * SGPT less than 2 times normal Renal: * Creatinine clearance greater than 50 mL/min Other: * No human-anti-murine-antibody response to prior murine monoclonal antibodies * No immunological or inflammatory disease (e.g., lupus erythematosus) * No active serious infection * No other serious medical condition that would limit survival to less than 2 years * No other active malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix * No psychiatric or addictive disorder that would preclude study * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior immunotherapy allowed Chemotherapy: * See Disease Characteristics * No concurrent chemotherapy Endocrine therapy: * Concurrent steroids for adrenal failure or adverse reactions to study drug allowed * Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed Radiotherapy: * Not specified Surgery: * Not specified
References
Publications (0)
Data not yet available